- Email: [email protected]
Balloon Tamponade in the Radiological Diagnosis of Esophageal Varices
Vol. 50, "10. I
G ASTROENTEROLOGY
Copy right © 1966 by The Williams & Wilkins Co.
Printed -ill U.S.A.
BALLOON TAMPONADE IN THE RADIOLOGICAL DIAGNOSIS OF ESOPHAGEAL VARICES HAROLD
O.
CO NN , M.D., RICHARD H. GRE E N SPAN, M.D., ARTHUR R. C LE :\I E TT,
M.D., J OHN R . MITCHELL, M.D., AND M URRAY B R ODOFF, M.D.
Departments o f I n ternal Medicine and Radiology , Yale University S chool of ill edicine , New Haven, and the V eterans Administration Hospital, West Haven, ConnectIcut
inations. This study is one of a series designed to evaluate and improve the diagnosis of esophageal varices. 6 , 7 , 15
The diagnosis of esophageal varices by the usual techniques of barium examination of the esophagus and esophagoscopy is frequently unsatisfactory. Although the accuracy of each of these diagnostic methods has been confidently proclaimed by its advocates,l-5 these techniques frequently provide discordant diagnoses in the same patients. 4 , 6 , 7 E sophageal varices have also been demonstrated by splenoportographY,8-10 but the accuracy of this more formidable procedure has not been establishedY-13 In 1959, Nathan described ba~loon t amponade of the esophagus as an adJunct to the radiological diagnosis of esophageal varices. H In this technique, a balloon is inflated in the esophagus to impede blood flow and distend the varices. Although its accuracy and reliability have not yet been evaluated, this technique has been used here and elsewhere with apparent success. The present investigation was undert aken to determine whether intraluminal balloon tamponade of the esophagus improved the diagnostic accuracy and reliability of the conventional barium esophagogram. Implicit in this study, in which multiple observers participated, was the estimation of the degree of observer variation and its effect on the comparison of conventional and balloon t amponade exam-
Methods and Materials
One hundred fifty-two male patients, who had been admitted to the West H aven Veterans Administration Hospital between October 1960 and June 1963, were included in this investigation. This series included the great majority of cirrhotic patients admitted during this interval, none of w hom had active upper gastrointestinal bleeding. Each patient was first examined for esophageal varices by conventional barium contrast examination. Immediately afterward a double-lumen, single-balloon tube (fig. 1) was passed into the esophagus and the balloon inflated below the level of the carina trachae (fig. 2) and the examination repeated. All radiological examinations were carried out by, or under the close supervision of, the three participating radiologists (A. C., R. G., J. R. M.). After completion of the examination the films were interpreted for the presence or absence of esophageal v arices by the fluoroscopi sts (flu oroscopic-radiological interpretation) . Esophagoscopic examinations, all of which were carried out by the same endoscopist (M. B.) , were performed 2 to 3 hr after the radiological studies. The EderHufford esophagoscope with 4-power magnification was used in all examination s. No morbidity w as encountered in this series of patients. The examiners were unaware of the patients' histories or clinical findings, and their interpretations were recorded promptly without knowledge of each other 's diagnoses. Alt hough the examiners realized
ReceiVed August 3 , 1965. Accepted September 24, 1965. . Address requests for reprints t o: Dr. Harold O. Conn, Veterans Administration Hospital, West H aven, Connecticut 06516. The authors are indebted to th e residents and fellows in gastroenterology and radiology who participated in this investigation, and to the many t echnicians and clerical p ersonnel who assist ed in various aspects of the study.
29
30
Vol. 50, No.1
CONN ET AL.
FIG. l. The double-lumen, single-balloon esophageal tube wbich is similar to the tube used by Nathan," was designed by R. H. Greenspan and manufactured by Davol Rubber Co. The tube is 26 cm long. The balloon, which is 2.7 em in diamet er inflated, is located 1.5 em from the distal end of the tube.
th at most of the patients would have cirrhosis, they knew that some noncirrhotic patients would be included. Conventional and balloon tamponade examinations were randomized and assigned code numbers. .Each of the radiologists then interpreted all the conventional esophagograms and, separately, all of the balloon tamponade examinations for the presence or absence of esophageal varices (radiological interpretation 1). At least two of the three radiologists considered 30 of the 152 examinations technically unsatisfactory. Reasons for rejection included inadequate coating of the esophagus, unsatisfactory position of the balloon , or poor radiographic technique. These 30 examinations were excluded from the final interpretation. The final group of 122 examinations included 111 cirrhotic and 11 noncirrhotic patients. One hundred four patients had Laennec's cirrhosis, four postnecrotic cirrhosis, and three hemochromatosis. The diagnosis was confirmed histologically in all except one of the cirrhotic patients.
Twenty-seven of the cirrhotic patients had had portacaval anastomoses. The noncirrhotic group included four with fatty infiltration, two with congestive hepatomegaly, and five with miscellaneous disorders. This group of 122 examinations was rerandomized, assigned new code numbers, and examined independently several months later by the same radiologists (radiological interpretation II). Each radiologist first interpreted the conventional esophagogram and immediately recorded his diagnosis. The balloon tamponade examination was then evaluated in conjunction with the esophagogram and the final impression recorded (combined examination). None of the investigators discussed his findings with his colleagues during the whole period of the investigation. Unless otherwise indicated, all computations were based on radiological inte?pretation II. Results
The diagnoses of the different examiners in the whole series of patients are shown in table l. Esophagoscopy. Esophageal varices were reported by esophagoscopy in 42 of the 122 patients (34%) and in 36 of the 84 cirrhotic patients without portacaval anastomoses (43 %) (table 2, Fig. 3). Fluoroscopic-radiological examination . Esophageal varices were reported by fluoroscopic-radiological examination in 52 of the 122 patients (43%) and in 40 of the 84 nonshunted cirrhotic patients (48%) (table 2, fig. 3). Radiological interpretation II. The frequency of esophageal varices reported by the three radiologists in the combined examination ranged from 40 (33%) to 72 (59 %) of the 122 patients, and from 33 (39%) to 49 (58%) of the 84 cirrhotic patients without portacaval anastomoses (table 2). The radiologists disagreed more frequently in their interpretations in noncirrhotic and shunted-cirrhotic patients than in cirrhotic patients without portacaval anastomoses (fig. 3). Note also that radiologist A reported the lowest and radiologist B the highest incidence of esophageal varices in each of the subgroups (fig. 3). It is inter-
January 1966
ESOPHAGEAL V.4RICES BALLOON TAMPO NA DE
31
FIG. 2. On the left, a spot film of the distal esophagus taken during conventional barium contrast examination, shows no varices. On the right, during balloon tamponade, the spot film shows a pattern suggestive of esophageal varices in the te rminal esophagus.
esting that radiologist C in radiological interpretation I also made the diagnosis of esophageal varices (combined examination) more frequently than his colleagues (fig. 4). In that preliminary series of interpretations, which was carried out 4 months earlier, radiologist B, not A, reported the lowest incidence of varices in each of the three subgroups of patients. This difference was caused by a large fluctuation in the number of diagnoses of esophageal varices made by radiologist A in the two interpretations, rather than any significant change in the number of varices reported by radiologist B, whose diagnoses were quite consistent in the two series of readings (table 2). Comparison oj conventional esophagograms with balloon tamponade examinations. Esophageal varices were reported by the three radiologists by conventional examination in 31 (25%), 48 (39%), and 37 (30%), respectively, and by combined ex-
amination in 40 (33 %), 57 (47%), and 72 (59%), respectively, (fig. 4). Each radiologist reported a higher incidence of esophageal varices by balloon tamponade examination than by conventional esophagogram. The diagnoses made on conventional examination agreed with those on balloon tamponade in 310 of the 366 interpretations (85%) by the three radiologists. The diagnosis of "no esophageal varices" on conventional examination was changed to "esophageal varices" on the basis of the balloon t amponade examination on 53 occasions in 43 patients. Radiologist A made this change in diagnosis on nine occasions (7%), radiologist B on nine occasions (7%), and radiologist C on 35 occasions (29 %) (table 3). All three radiologists agreed that in two of these patients (nos. 15, 32) esophageal varices, which were not evident on the conventional esophagogram, were present after balloon tamponade of the esophagus. In six additional patients
No.
12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
10 11
9
2 3 4 5 6 7 8
I
---
Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis L aennec's cirrhosis, PCS L aen nec's cirrhosis Hemochromatosis Laennec 's cirrhosis, carcinoma of pancreas Laennec's cirrhosis, PCS L aennec's cirrhosis, SRS Laen nec's cirrhosis, PCS Laennec's cirrhosis Hemochromatosis Laennec 's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis Hypogammaglobulinemia Laennec's cirrhosis L aennec's cirrhosis , PCS Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis, PCS Laennec's cirrhosis, P CS Congestive heart fa ilure Laennec's cirrhosis Congestive heart failure Laennec's cirrhosis
-
0 + + 0 + 0 0 0 0 + 0 + 0 + 0 + + 0 0 0 0 0 0 0 0
+ 0 + 0 0 0
+b
E -
-
+ + + 0 + 0 0 + 0 + 0 0 0 + 0 + + + + 0 + 0 + 0 +
Dc 0 + 0 0 + 0
-
X
0/ 0 0/ 0 + /0 0 /0 0/0 0/0 +/+ 0/ + 0/ 0 +/+ 0/0 0/0 0/0 0/ + 0 /0 + /+ +/+ +/+ 0/0 0/ 0 0/ + 0/ 0 +/+ 0/0 0/+
O/()d 0/0 0/0 0/0 0/ 0 +/+ 0/0 +/+ +/+ +/+ 0/ 0 0/0 0/0 +/+ 0/ + 0/ 0 0/ + 0/ 0 0/0 0/0 + /+ 0/ 0 +/+ 0/ 0 +/+ 0/0 0/ 0 + /+ 0 /0 +/+ 0/0 0/+
0/0 0/0 0/0 +/+ 0/0 +/+ 0/ 0
All BII - -- - - -
+/+ +/+ +/+ 0 /0 0/0 0/0 +/+ 0/+ 0/ + 0/ + 0/0 0/0 0/+ +/+ +/+ +/+ +/+ +/+ +/+ 0/ + +/+ 0/ + +/+ 0/0 0/+
0/+ 0/+ +/+ + /+ 0 /0 +/+ 0/0
CIl
74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94
73
72
71
66 67 68 69 70
64 65
62 63
No.
-
- -
Laennec 's cirrhosis Postnecrot ic cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis, PCS Laennec's cirrhosis Laennec's cirrhosis, PCS Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis, PCS Laennec 's cirrhosis Hemochromatosis Laennec 's cirrhosis Laennec 's cirrhosis Postnecrotic cirrhosis Laennec's cirrhosis, PCS Laennec's cirrhosis Laennec's cirrhosis, PCS Laennec's cirrhosis Laennec 's cirrhosis, PCS Laennec 's cirrhosis Laennec 's cirrhosis, PCS Laennec 's cirrhosis , PCS Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Gastric ulcer Laennec's cirrhosis
Diagnosis
0 0 0 0 + 0 0 + 0 0 0 + + + 0 0 0 + 0 0 0 + 0 + 0 + 0 0 + 0 0 0 +
E
0 + 0 0 + 0 0 + 0 0 0 0 0 + 0 0 0 0 0 0 0 + + + 0 + + 0 0 0 0 0 0
X
0/0 +/+ 0/ 0 0/ 0 + /+ 0/0 0/0 +/+ 0/ 0 0/ 0 0/ 0 0/ 0 0/+ 0/0 0/ 0 0/ 0 0/ 0 +/+ 0/0 0/0 0 /0 0/ 0 0/ 0 0/ 0 0/0 +/+ 0/ + 0/ 0 0/ 0 0/ + 0/0 0/0 0/ 0
All
- - - - - --
1. Comparison of esophagoscopic (E), fluoroscopic-radiological (X), and radiological (All, BIl, CIl) di agnoses of esophageal varices
DiagnosisG
TABLE
-
0/0 0/0 0/0 0/ 0 0/ + 0/ 0 0/0 +/+ 0/0 0/ 0 0/ 0 0/ 0 +/+ 0/0 0/0 0/ 0 +/+ +/+ 0/0 0/0 +/+ +/+ +/+ +/+ +/+ +/+ 0/0 0/ 0 +/+ 0/0 0/ 0 0/0 0/0
BIl --
ClI
- - 0/0 0/ 0 0/ 0 0/ 0 0/ + 0/+ +/+ +/+ 0/ + 0/ 0 0/0 0/0 +/+ +/+ 0/ + 0/ 0 0/ 0 +/+ 0/0 0/0 0/0 0/ 0 0/ 0 +/+ 0/0 +/+ 0/ + 0/ 0 0/0 0/ + 0/0 0/0 0/ 0
t:tJ
......
~
~
~
~
;...
'-3
8 ~
W t-:l
=
+
pes
b
=
---
a
--
Laennec 's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis Portal vein t hrombosis Laennec's cirrhosis Laennec's cirrhosis L aennec's cirrhosis Laennec 's cirrhosis, pes Duodenal ulcer Laennec's cirrhosis, pes Laennec's ci rrhosis Laennec's cirrhosis Fatty liver Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis, pes Laen nec's cirrhosis Laennec's cirrhosis F atty liver Laennec's cirrhos is Achlorhydria Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec 's cirrhosis Fatty liver Laennec's cirrhosis F atty liver
+ + + + + 0 + + 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 + 0 0 0 0 + + + + 0 + 0 0 0 + 0 0 + 0 + 0 0 0 0 0 0 + 0 0 + 0 + 0 0 0
+/+ +/+ +/+ 0/ 0 +/+ 0/0 0/0 + /0 0/0 0/0 0/0 +/+ 0/ 0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/+ 0/0 0/0 +/+ 0/0 +/+ 0/0 0/0 0/0 +/+ +/+ + /+ 0/0 + /+ 0/ 0 0/ 0 +/+ 0/0 0/0 0/0 0/0 0/ + + /+ 0/0 +/+ + /+ 0/0 0/ 0 +/+ 0/+ 0/0 0/0 + /+ 0/+ +/+ 0/0 0/0 0/0
+/+ +/+ +/+ 0/ 0 +/+ 0/0 0/0 +/+ 0/ + 0/ + 0/0 0/ + 0/ 0 0/0 0/ 0 0/ + +/+ 0/+ 0/0 0/+ 0/ 0 0/ 0 0/ + +/+ 0/ 0 0/ + 0/0 0/ 0 I 0/ 0
95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 Laennec's cirrhosis Laennec's cirrhosis Postnecrotic c irrhosis, pes Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis, pes Laennec's cirrhosis Laennec's cirrhosis , pes Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis, pes Laennec's cirrhosis Laennec 's cirrhosis Postnecrotic cirrhosis, pes Laennec's cirr hosis Laennec's cirrhosis, pes Laennec's cirrhosis, pes Laennec's cirrhosis Postnecrotic cirrhosis Laennec's cirrhosis , pes Laennec's cirrhosis Laennec's ci rrhosis Laennec's cirrhosis, pes Laennec 's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis
0 0 0 + 0 0 0 + 0 + 0 0 + 0 0 0 0 0 0 + + + + 0 0 + + + + + 0 + + 0 0 + + 0 0 0 + 0 + + 0 + + 0 + + + 0 0 + + + +/+ +/+
+1+
0/ 0 + /+ 0/ 0 0/ 0 0/ 0 0/0 0/0 +/+ + /+ +/+ 0/ 0 0/0 +/+ 0/ 0 0/ 0 0/ 0 0/ 0 +/+ 0/0 0/ 0 +/+ 0/ 0 0/+ 0/0 0/0
0 /0 + /+ 0 /0 0 /0 0/0 +/+ +/+ +/+ 0/ 0 +/+ 0 /0 +/+ +/+ +/+ 0/+ 0 /0 0 /0 +/+ 0/0 +/+ + /+ 0 /0 0/ 0 +/+ 0/ + +/+ +/+ + /+ 0/ + +/+ 0/+ +/+ 0/0 0/ + 0/+ +/+ 0/+ +/+ 0/0 + /0 0/+ 0/0 0/0 0/+ 0/0 +/+ 0/0 0/ + 0/ + 0/0 0/ + 0/ + 0/ 0 +/+ 0/+ +/+
Portacaval shunt ; SRS = splenorenal shunt. Esophageal varices. c O = No esophageal varices . d The symbol above the diagonal line represents the diagnosis by conventional esophagogram an d t he symbol below represents t he final diagnosis based on conventional plus balloon tamponade examination.
-
57 58 59 60 61
56
33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55
CA:l CA:l
~ ~
6
~
~
~
o
8
t.-<
~
"-l
~
~
~
~t.-<
~
~'"i:I
~
<0
~ ......
I
"-<
34
CONN ET AL. T.\BLE
Vol. 50, No.1
2. Summary of diagnoses by individual observers Cirrhotic patients
Examination
Esophagoscopic Fluoroscopic-Radiological Radiological I Radiologist A Radiologist B Radiologist C Radiological II Radiologist A Radiologist B Radiologist C
Without portacaval anastomoses (84)
With portacaval anastomoses (27)
Esophageal varices
Esophageal varices
N oncirrhotic patients (11)
Total group (122)
Esophageal varices
Esophageal varices
no.
%
no.
%
no.
%
no.
%
36 40
43 48
3
11
27 18
42 52
34 43
46 40 62 33 41 49
10
37
3 2
55 48 74
12 19
44 37 70
6 4 5
55 36 45
64 54 86
52 44 70
39 49 58
6 13 18
22 48 67
1 3 5
9 27 45
40 57 72
33 47 59
10
I
125
100
NUMBER
OF PATIENTS
ESOPHAGOSCOPIC
ESOPHAGEAL VARICES NO ESOPHAGEAL VARICES
n
n
FLUOROSCOPIC RADIOLOGIC RADIOLOGIC RADIOLOGIC RADIOLOGIC A B C
l~ WHOLE
SERIES
I CIR~HOSIS I
n
CIRRHOSIS C PORTOCAVAL ANASTOMOSIS
FIG. 3. Frequency of diagnosis of esophageal varices by various diagnostic techniques. Each set of four bars shows from left to right the total series of patients, cirrhotic patients without portacaval anastomoses, cirrhotic patients with portacaval anastomoses, and the noncirrhotic patients. The height of the bars shows the number of patients. The upper portion of each bar, unshaded, or cross-hatched, shows the number without esophageal varices. The lower, black portion of each bar indicates the number with esophageal varices.
(nos. 17, 53, 66, 88, 91, 117), two of the three radiologists made similar observations. In the other 35 patients only one of the three radiologists believed that the balloon examination alone demonstrated esophageal varices, and almost all of these
were so interpreted by radiologist C. In three patients one of the radiologists thought that balloon tamponade obscured esophageal varices which were apparently present on conventional examination. Diagnostic validity of radiological inter-
ESOPHAGEAL VARICES BALLOON TAMPONADE
January 1966
125 100
NUMBER
75
OF PATIENTS 50
I
25
O~·IU.nL-~I~~nL---I~n~----~I~n~~~I~n~~~I~nLRADIOLOGIST
B
A
CAB
CONVENTIONAL ESOPHAGOGRAM
C
COMBINED EXAMINATION
FIG. 4. Comparison of diagnoses of esophageal varices by conventional and balloon tamponade examinations. On radiological interpretations I and II the height of the bars represents the number of patients examined. The lower, black portion of each bar shows the patients with esophageal varices; the upper, unshaded portion those without esophageal varices.
pretation. The radiologists agreed with each other in 258 of the 366 paired interpretations of the 122 complete radiological examinations (70%) (table 4). The interobserver error, which was based on 108 diagnostic disagreements in 366 pairs of interpretations (30%), ranged from 25 to 34% for the three pairs of radiologists. Interobserver error was lower (20 to 24%; mean, 21 %) when the radiological examinations were based on conventional esophagograms alone; i.e. excluding balloon tamponade examinations (table 4). Furthermore, the three radiologists unaninously agreed on the radiological diagnosis based on conventional esophagograms in 83 of the 122 patients (69%), but in only 68 of the 122 patients (56%) based on combined examinations. 3. Influence of esophageal tamponade on the radiological diagnosis of esophageal varices
TABLE
No varices No varices Varices by byesophag- byesophag- esophagogramU ograma ogramU
Varices by esophagograma
No varices by balloon tamponade
Varices by baJloon tamponade
No varices by baJloon tamponade
Varices by baJloon tamponade
82 65 50
9 9 35
2 0 1
29 48 36
Radiologist
A B C a
Conventional esophagogram.
TABLE
4. Observer variation in the radiological diagnosis of esophageal varices
I Complete radiological examination a
Conventional esophagogram Radiologis ts
Diagnostic Diagnostic Diagnostic Diagnostic agreement disagree- agreement disagreement ment
no.
I nterobserver variation A vs. B 93 A vs. C 98 Bvs.'C 97 Total 288 Intraobserver variation Avs. A B vs. B C vs. C Total
%
no.
%
%
no.
I
%
I
I
76 80 80 79
29 24 25 78
24 91 75 31 I 20 86 70 36 20 81 66 41 21 258 70 108
25 30 34 30
I
I
100 113 100 313
82 93 82 86
22 9 22 53
18 92 7 108 18 93 i4 293
75 89 76 80
Conventional esophagogram plus tamponade examination. a
no.
30 14 29 73
25 11
I
24 20
balloon
Decreased diagnostic reliability for the balloon tamponade examinations was also found in comparing the radiological interpretations of the three radiologists with their own prior diagnoses (intraobserver error). Based on the combined radiological
36
Vol. 50, No.1
CONN ET AL. 5. Comparison of esophagoscopic and radiological diagnosis of esophageal varices
TABLE
Agreement between esophagoscopic and radiological diagnoses Radiological examina tion
Fluoroscopicradiological Radiological interpretation I Radiologist A Radiologist B Radiologist C Total Radiological interpretation II Radiologist A Radiologist B Radiologist C Total
Conventional barium contrast examina tion
Combined conventional plus balloon tamponade examina tions
no.
%
68 73 70 70
78 82 62 222
64 67 51 61
75 69
88 79
72 65
73 72
239
no.
%
82
67
83 89 86 258
92 84 89 265
72
59 65
examination, they disagreed with their earlier diagnoses in 25,11, and 24%, respectively (mean, 20%) (table 4). Intraobserver variation, based on conventional radiological examination, was 18, 7, and 18%, respectively (mean, 14%) for the three radiologists (table 4). Comparison of esophagoscopic and radiological interpretation II. Radiological interpretation of the conventional examinations by the three radiologists agreed with the esophagoscopic diagnosis in 75, 69, and 73%, respectively (table 5). Diagnostic agreement between the conventional radiological and the endoscopic interpretations was higher than between the balloon tamponade and the endoscopic findings for each of the three radiologists (72, 65, and 59%, respectively, table 5). A similar pattern was observed in the mdiological interpretation I in which the diagnosis of esophageal varices by routine esophagogram agreed with the endoscopic diagnosis more frequently than did the balloon esophagogram (table 5). Esophageal varices were reported by the esophagoscopist in only 11 of the 43 patients (26%), in whom esophageal varices were diagnosed by balloon tamponade but not by the conventional esophagogram.
Neither of the two patients (nos. 15, 32) in whom balloon tamponade unanimously resulted in a diagnosis of esophageal varices had varices by esophagoscopy. Thus, the endoscopic-radiological agreement was much lower than anticipated in those instances in which the diagnosis of varices was based solely on balloon tamponade. Although it is not known which of these techniques was correct in individual patients, the failure of the radiologists to confirm each other in the large majority of those instances in which the diagnosis of esophageal varices was based on the balloon tamponade examination, however, casts doubt on the accuracy of the balloon technique. Furthermore, the endoscopic diagnosis concurred with the unanimous conventional radiological diagnosis in 69 of the 83 patients (83 %) in whom the three radiologists agreed, but agreed in only 66 of the 117 nonunanimous interpretations (56%). This difference was highly significant stastistically (P < 0.001). Similarly, esophagoscopic agreement with radiological diagnoses based on combined examination occurred in 51 of the 68 unanimous diagnoses (75%), but in only 89 of the 162 nonunanimous radiological interpretations (55%). This difference, too was highly significant (P < 0.001). Discussion
Clinical diagnosis of esophageal varices. Investigation of the accuracy of the diagnosis of esophageal varices is limited by the difficulty of determining with certainty whether or not esophageal varices are present in a given patient. The present study, which was undertaken to evaluate the role of balloon tamponade in the radiological diagnosis of varices, is thus hindered by the very inadequacies it seeks to correct. Each of the techniques currently used for the diagnosis of esophageal varices is limited by intrinsic deficiencies of the method, by observer variation, or both. The validity of barium contrast examination of the esophagus, which is the standard method of demonstrating esophageal varices, has recently been questioned. 4 - 6 Esophagoscopy, which is a more difficult and potentially more dangerous procedure than the barium
January 1966
ESOPHAGEAL VARICES BALLOON TAMPONADE
esophagogram, is also hindered by observer variability.7. 15 In addition, it has been reported that esophageal varices seen on one esophagoscopic examination may sometimes disappear and reappear without great change in the patient's clinical state. 16. 17 Whether such observations represent observer variation or fluctuation in portal hemodynamics is unknown , however. Splenoportography, which is a more difficult and hazardous diagnostic procedure, can also be used to demonstrate esophageal varices.8-10 Disagreements between the splenoportographic findings and the results of other diagnostic techniques occur, however.11-13.18-20 It is also uncertain whether collateral vessels seen to flow toward the esophagus during splenoportography represent true submucosal varices of the esophagus which may bleed massively, or periesophageal veins which are not a serious threat to the patient. B• 2o Although no controlled investigation of splenoportography in the diagnosis of esophageal varices has yet been reported, it is probable that observer variability of similar magnitude exists in the interpretation of splenoportograms. Although the diagnosis of esophageal varices has been made with certainty at esophagotomy,21 such surgery cannot be justified solely for diagnostic purposes, and can only serve as an occasional means of diagnostic confirmation. Even postmortem findings cannot be used as proof of the presence or absence of esophageal varices at some earlier time. 22 . 23 Since the presence or absence of esophageal varices cannot be established unequivocally, the data in the present study were necessarily based on clinical observations. The esophagoscopic diagnosis was employed, not as an absolute index of the presence or absence of esophageal varices but as a relative point of reference. Obse1'ver variation. Since both the radiological and the endoscopic diagnosis of esophageal varices are subjective interpretations, the degree of observer variability must be considered in assessing the diagnostic accuracy of balloon tamponade. Observer variation in medicine may be defined as disparities in the diagnosis of the
37
presence, absence, or degree of an abnormality based on serial interpretations of clinical history, physical examination, roentgenograms, histological slides, or other clinical or laboratory data. Differences between observers are known as interobserver variation and between serial interpretations by the same observer as intraobserver variation. Interobserver error has ranged from 20 to 35% in a variety of investigations and intraobserver error from 15 to 25%.24. 25 Factors responsible for observer variation include the skill and experience of the observers, the nature of the judgment required, the technical quality of the examination, and the conditions of interpretation, as well as the personality and motivation of the observers. In this study the observers were highly skilled, experienced radiologists. They were required to decide simply whether or not esophageal varices were present, but not to grade the magnitude of the varices. Technically inadequate films had been excluded by the participants during a preliminary interpretation of the films. Roentgenograms were read in groups of lO examinations or less under conditions selected by the individual radiologists, all of whom had volunteered to participate. Despite these measures, observer variation of considerable magnitude was encountered. The three radiologists disagreed with each other in approximately 20% of conventional esophagograms and with their own prior interpretations in about 15%. This degree of observer error is in accord with previous estimates in the diagnosis of esophageal varices,6 chest roentgenograms,26. 27 abdominal films,28 and other diagnostic techniques,24.25 A higher incidence of both inter- and intraobserver error was noted in the interpretation of balloon tamponade examinations (28 and 20%, respectively), The higher incidence of observer variation (P < 0.05) with balloon tamponade than with conventional examinations was observed in each of the three radiologists, These observations indicate that the criteria for the diagnosis of esophageal varices not only differ among radiologists, but may change greatly in individual radiologists over relatively short periods of
38
CONN ET AL.
Vol. 50, No.1
time. In addition, they suggest that the of balloon tamponade were not erroneous. criteria for the interpretation of esophag- Perhaps inflation of the esophageal balloon {)al varices by balloon tamponade exami- made visible small esophageal varices nation are less precisely defined than for the which were not evident on conventional more familiar conventional esophagogram. radiological examination. The lack of Comparison of endoscopic and radiolog- agreement among the three radiologists in ical diagnoses. The endoscopic diagnosis of these instances argues strongly against this esophageal varices agreed with conven- hypothesis. It is more likely that the prestional radiological diagnosis in approxi- ence of the balloon in the esophagus caused mately three-fourths of the examinations. artifacts compatible with esophageal varThese findings confirm previous observa- ices. We observed, for example, that the intions of esophagoscopic-radiological agree- flated balloon induced active propulsive ment in the diagnosis of esophageal var- peristalsis and, frequently, tertiary contracices. 6. 7 Inclusion of balloon tamponade tions which sometimes simulated esophagexaminations, however, resulted in a lower eal varices. It is also probable that subincidence of radiological-endoscopic agree- conscious bias in favor of the diagnostic ment, i.e. less than two-thirds of the ex- value of balloon tamponade may have aminations. The incidence of discordant caused overenthusiastic interpretation of endoscopic-radiological diagnoses (25 to esophageal varices. Although all three 31 %) was only slightly higher than the radiologists reported esophageal varices frequency of disagreement among radiolo- more frequently by balloon tamponade gists who read the same films (19 to 24%),6 than by conventional examination, one of and not appreciably different from the in- the radiologists (C) made such diagnoses cidence of disagreement between esophagos- on 35 occasions, four times more comcopists who examined cirrhotic patients monly than his colleagues. These 35 interfor esophageal varices during the same pretations alone account for most of the endoscopic examination (33%).7.15 These discrepancies observed between the conobservations suggest that the effect of ventional and balloon tamponade examinaobserver variation alone would result in tions. discordant diagnoses between endoscopic Incidence of esophageal varices in cirand radiological techniques in more than rhosis. Esophageal varices were observed one-fourth of patients examined. Conse- in cirrhotic patients (excluding cirrhotic quently, one must expect disagreements be- patients with portacaval anastomoses) in tween two diagnostic techniques at least this study by esophagoscopy in 43%, by as frequently as the incidence of observer fluoroscopic-radiological examination in variation inherent in the techniques em- 48%, and by conventional esophagograms ployed. in 35% (30 to 42%) (fig. 5). Although these Effect of balloon tamponade examination findings confirm the radiological and enon the radiological diagnosis of esophageal doscopic incidence of varices found in cirvarices. Balloon tamponade appeared to rhosis in this laboratory,6. 7. 15 and elsediminish both the diagnostic accuracy and where,2. 30. 31 they are at variance with other validity of conventional barium contrast reports. Brick,5 Sullivan and Myers,29 and examination of the esophagus. This was Greene et al.,13 have reported higher intrue for diagnostic agreement of each of the cidences of esophageal varices in cirrhosis three radiologists with the endoscopic diag- by esophagoscopy (73 to 90%) and Friednoses, with the fluoroscopic-radiological berg et aU a lower incidence (30%). They diagnoses, with each other's radiological also found a lower incidence (24 to 28%) of diagnoses and with their own previous esophageal varices radiologically,4. 5. 29 than was found by us or other authors.2. 30. 31 radiological diagnoses. What is the explanation for the apparent These observations suggest that differences deleterious effect of balloon tamponade on in criteria for both the endoscopic and rathe radiological diagnosis of esophageal diological diagnosis of esophageal varices, varices? It is conceivable that the findings as well as differences in the selection of pa-
January,1966
ESOPHAGEAL VARICES BALLOON TAMPONADE
39
ESOPHAGEAL VARICES
in percent
o ESOPHAGOSCOPY
FLUOROSCOPIC RAOIOLOGIC
ABC CONVENTIONAL RADIOLOGIC EXAMINATION
FIG. 5. Incidence of esophageal varices in cirrhosis. The lower, black portion of each bar represents the percentage of patients reported to ha ve esophageal varices, and the upper, unshaded portion the percentage without varices.
tients, probably account for the various results of different investigators. . Comments. Balloon tamponade in our hands decreased both the diagnostic accuracy and reliability of the conventional radiological diagnosis of esophageal varices. Furthermore, this investigation did not establish the diagnostic superiority of either esophagoscopy or conventional barium contrast examinations. These findings demonstrate the potential dangers of observer variability in clinical investigations and emphasize the necessity of designing such investigations to minimize the effects of observer error. Although each of these methods is susceptible to the errors of subjective interpretation, diagnostic agreement by both techniques minimizes the incidence of observer error and provides dependable evidence of the presence or absence of esophageal varices. In patients in whom the radiological and endoscopic methods fail to agree, however, further diagnostic efforts are mandatory. These include careful re-examination by the conventional radiological technique,30. 31 with interpretation by several radiologists, and by esophagoscopy with evaluation by several endoscopists if possible. In addition, other m ethods such as splenoportography, measurement of splenic pulp pressure, or evaluation of ammonia tolerance 32 may be helpful in arriving at the correct diagnosis. The necessity of employing multiple methods emphasizes the need for an accurate and reliable technique for the diagnosis of esophageal varices.
SUInmary This investigation was undertaken to evaluate the accuracy and reliability of balloon tamponade of the esophagus as an adjunct to the radiological diagnosis of esophageal varices. One hundred twentytwo patients, including 111 with cirrhosis, were studied successively by conventional barium contrast examination, by balloon tamponade examination, and by esophagoscopy. Three radiologists independently interpreted the conventional esophagograms alone and in conjunction with the balloon tamponade examination. Esophageal varices were found in 25 to 39% of the patients by conventional esophagogram, in 33 to 59% by the combined radiological interpretation, and in 34% by esophagoscopy. The incidences of both inter- and intraobserver error were lower with conventional than with balloon tamponade radiological examination. Similarly, diagnostic agreement of endoscopic findings was higher with conventional than with balloon tamponade examination. Balloon tamponade examination not only failed to improve the radiological diagnosis of esophageal varices but it appeared to decrease the accuracy and reliability of the radiological diagnosis of esophageal varices. The importance of designing such investigations to minimize observer variation was emphasized. REFERENCES 1. Ritvo, M., and 1. A. Shauffer. 1952. Gastrointestinal x-ray diagnosis, p. 838. Lea & Febiger, Philadelphia.
40
CONN ET AL.
2. Evans, K. T. 1959. Accuracy of examination of
the esophagus with barium in the diagnosis of esophageal and gastric varices. Brit. J. Radiol. 32: 233-240. 3. Evans, J. A., and M. A. Payne. 1958. Studies of esophageal varices before and after portacaval shunts. ArneI'. J. Roentgen. 79: 760767. 4. Friedberg, S. A., H. D. Bennett, H. Singh, and J. Lindberg. 1955. Esophageal varices in hepatic cirrhosis. An endoscopic study. Ann. Otol. 64: 599-608. 5. Brick, 1. B. 1961. Esophagoscopy by and for the internist: A review of results in a thousand patients. Amer. J. Med. Sci. 241: 289-294. 6. Conn, H. 0., J. R. Mitchell, and M. G. Brodoff. 1961. A comparison of radiologic and esophagoscopic diagnosis of esophageal varices. New Eng. J. Med. 265: 160-164. 7. Conn, H. 0., H . Smith , and M. Brodoff. 1965. Observer variation in the diagnosis of esophageal varices by esophagoscopy. New Eng. J. Med. 272: 830-834. 8. Atkinson, M., E. Barnett, S. Sherlock, and R. E. Steiner. 1955. The clinical investigation of the portal circulation, with special reference to portal venography. Quart. J. Med. 24 : 77-91. 9. DeWeese, M. S., M. M. Figley, W. J. Fry, R. Rapp, and H. L. Smith. 1957. Clinical appraisal of percutaneous splenoportography. Arch. Surg. (Chicago) 75: 423--435. 10. Panke, W. F., E. G. Bradley, A. H. Moreno, F . F. Ruzicka, and L. M. Rousselot. 1959. Techniques, hazards and usefulness of percutaneous splenic portography. J. A. M. A. 169: 1032-1037. 11. Fuld, H., and D. T. Irwin. 1954. Clinical application of portal venography. Brit. Med. J. 1: 312-313. 12. Doppman, J. L., and R. L. Shapiro. 1961. Bleeding esophageal varices in the presence of a normal splenoportogram. Amer. J. Roentgen. 86: 1103-1107. 13. Greene, L ., H . Weisberg, W. S. Rosenthal, P. A. Douvres, and D. Katz. 1965. Evaluation of esophageal varices in liver disease by splenic-pulp manometry, splenoportography and esophagoscopy. Diagnostic discrepancies. Amer. J. Dig. Dis. 10: 284- 292. 14. Nathan, M. H. 1959. Diagnosis of esophageal varices by a new radiologic method. Radiology 73: 725-732. 15. Conn, H . 0., H . W. Smith, and M. Brodoff.
Vol. 50, No.1
1965. Correspondence. New Eng. J. Med. 273 : 1052. 16. Bennett, H. D., C. Lorentzen, and L. A. Baker. 1953. Transient esophageal varices in
hepatic cirrh05is. Arch. Intern. Med. 92: 507-522. 17. Palmer, E. P. 1957. On the natural history of
esophageal varices. Ann. Intern. Med. 47: 18-26. 18. Steiner, R. E., S. Sherlock, and M. D. Turner. 1957. Percutaneous splenic portal venography. J . Fac. Radiol. 8: 158-177. 19. Figley, M. M., W. J. Fry, J. E. Orebaugh, and H. M. Pollard. 1955. P ercutaneous splenoportography. Gastroenterology 28: 153162. 20. Bergstrand, 1., and C. A. Ekman. 1955. Per-
21.
22.
23.
24.
25. 26.
27.
28.
29.
30. 31.
32.
cutaneous Lieno-portal venography. Acta Radiol. (Stockholm) 43: 377-392. Orloff, M. J ., and H. S. Thomas. 1963. Pathogenesis of esophageal varix rupture. Arch. Surg. (Chicago) 87: 301-306. Templeton, F. E. 1964. X-ray examination of the stomach, Rev. Ed., p. 598. University of Chicago Press, Chicago. Hare, H. F., E. Silveus, and F. A. Ruoff. 1948. Esophageal and gastric varices, with report of a case. Surg. Clin. N. Amer. 28: 729-732. Garland, L. H. 1959. Studies on the accuracy of diagnostic procedures. Amer. J. Roentgen. 82: 25-38. Lusted, L. B. 1960. Logical analysis in roentgen diagnosis. Radiology 74: 178-193. Garland, L. H. 1950. On the reliability of roentgen survey procedures. Amer. J. Roentgen. 64: 32--41. Yerushalmy, J. 1955. Reliability of chest radiography in the diagnosis of pulmonary lesions. ArneI'. J. Surg. 89: 231-240. Sloan, R. D. 1959. Roentgenologic evaluation of mesenteric small intestinal obstruction. ArneI'. J. Roentgen. 82: 978-984. Sullivan, B. H., Jr., and J. E. Myers. 1959. Gastroscopy and esophagoscopy: An analysis and discussion of 1752 procedures. Med. Ann. D. C. 28 : 442--446. Schatzki, R. 1940. Roentgen demonstration of esophageal varices; its clinical importance. Arch. Surg. (Chicago) 41: 1084-1100. Nelson, S. W. 1957. Roentgenologic diagnosis of esophageal varices. Amer. J. Roentgen. 77: 599-611. Conn, H. O. 1961. Ammonia tolerance as an index of portal-systemic collateral circulation in cirrhosis. Gastroenterology 41: 97106.
G ASTROENTEROLOGY
Copy right © 1966 by The Williams & Wilkins Co.
Printed -ill U.S.A.
BALLOON TAMPONADE IN THE RADIOLOGICAL DIAGNOSIS OF ESOPHAGEAL VARICES HAROLD
O.
CO NN , M.D., RICHARD H. GRE E N SPAN, M.D., ARTHUR R. C LE :\I E TT,
M.D., J OHN R . MITCHELL, M.D., AND M URRAY B R ODOFF, M.D.
Departments o f I n ternal Medicine and Radiology , Yale University S chool of ill edicine , New Haven, and the V eterans Administration Hospital, West Haven, ConnectIcut
inations. This study is one of a series designed to evaluate and improve the diagnosis of esophageal varices. 6 , 7 , 15
The diagnosis of esophageal varices by the usual techniques of barium examination of the esophagus and esophagoscopy is frequently unsatisfactory. Although the accuracy of each of these diagnostic methods has been confidently proclaimed by its advocates,l-5 these techniques frequently provide discordant diagnoses in the same patients. 4 , 6 , 7 E sophageal varices have also been demonstrated by splenoportographY,8-10 but the accuracy of this more formidable procedure has not been establishedY-13 In 1959, Nathan described ba~loon t amponade of the esophagus as an adJunct to the radiological diagnosis of esophageal varices. H In this technique, a balloon is inflated in the esophagus to impede blood flow and distend the varices. Although its accuracy and reliability have not yet been evaluated, this technique has been used here and elsewhere with apparent success. The present investigation was undert aken to determine whether intraluminal balloon tamponade of the esophagus improved the diagnostic accuracy and reliability of the conventional barium esophagogram. Implicit in this study, in which multiple observers participated, was the estimation of the degree of observer variation and its effect on the comparison of conventional and balloon t amponade exam-
Methods and Materials
One hundred fifty-two male patients, who had been admitted to the West H aven Veterans Administration Hospital between October 1960 and June 1963, were included in this investigation. This series included the great majority of cirrhotic patients admitted during this interval, none of w hom had active upper gastrointestinal bleeding. Each patient was first examined for esophageal varices by conventional barium contrast examination. Immediately afterward a double-lumen, single-balloon tube (fig. 1) was passed into the esophagus and the balloon inflated below the level of the carina trachae (fig. 2) and the examination repeated. All radiological examinations were carried out by, or under the close supervision of, the three participating radiologists (A. C., R. G., J. R. M.). After completion of the examination the films were interpreted for the presence or absence of esophageal v arices by the fluoroscopi sts (flu oroscopic-radiological interpretation) . Esophagoscopic examinations, all of which were carried out by the same endoscopist (M. B.) , were performed 2 to 3 hr after the radiological studies. The EderHufford esophagoscope with 4-power magnification was used in all examination s. No morbidity w as encountered in this series of patients. The examiners were unaware of the patients' histories or clinical findings, and their interpretations were recorded promptly without knowledge of each other 's diagnoses. Alt hough the examiners realized
ReceiVed August 3 , 1965. Accepted September 24, 1965. . Address requests for reprints t o: Dr. Harold O. Conn, Veterans Administration Hospital, West H aven, Connecticut 06516. The authors are indebted to th e residents and fellows in gastroenterology and radiology who participated in this investigation, and to the many t echnicians and clerical p ersonnel who assist ed in various aspects of the study.
29
30
Vol. 50, No.1
CONN ET AL.
FIG. l. The double-lumen, single-balloon esophageal tube wbich is similar to the tube used by Nathan," was designed by R. H. Greenspan and manufactured by Davol Rubber Co. The tube is 26 cm long. The balloon, which is 2.7 em in diamet er inflated, is located 1.5 em from the distal end of the tube.
th at most of the patients would have cirrhosis, they knew that some noncirrhotic patients would be included. Conventional and balloon tamponade examinations were randomized and assigned code numbers. .Each of the radiologists then interpreted all the conventional esophagograms and, separately, all of the balloon tamponade examinations for the presence or absence of esophageal varices (radiological interpretation 1). At least two of the three radiologists considered 30 of the 152 examinations technically unsatisfactory. Reasons for rejection included inadequate coating of the esophagus, unsatisfactory position of the balloon , or poor radiographic technique. These 30 examinations were excluded from the final interpretation. The final group of 122 examinations included 111 cirrhotic and 11 noncirrhotic patients. One hundred four patients had Laennec's cirrhosis, four postnecrotic cirrhosis, and three hemochromatosis. The diagnosis was confirmed histologically in all except one of the cirrhotic patients.
Twenty-seven of the cirrhotic patients had had portacaval anastomoses. The noncirrhotic group included four with fatty infiltration, two with congestive hepatomegaly, and five with miscellaneous disorders. This group of 122 examinations was rerandomized, assigned new code numbers, and examined independently several months later by the same radiologists (radiological interpretation II). Each radiologist first interpreted the conventional esophagogram and immediately recorded his diagnosis. The balloon tamponade examination was then evaluated in conjunction with the esophagogram and the final impression recorded (combined examination). None of the investigators discussed his findings with his colleagues during the whole period of the investigation. Unless otherwise indicated, all computations were based on radiological inte?pretation II. Results
The diagnoses of the different examiners in the whole series of patients are shown in table l. Esophagoscopy. Esophageal varices were reported by esophagoscopy in 42 of the 122 patients (34%) and in 36 of the 84 cirrhotic patients without portacaval anastomoses (43 %) (table 2, Fig. 3). Fluoroscopic-radiological examination . Esophageal varices were reported by fluoroscopic-radiological examination in 52 of the 122 patients (43%) and in 40 of the 84 nonshunted cirrhotic patients (48%) (table 2, fig. 3). Radiological interpretation II. The frequency of esophageal varices reported by the three radiologists in the combined examination ranged from 40 (33%) to 72 (59 %) of the 122 patients, and from 33 (39%) to 49 (58%) of the 84 cirrhotic patients without portacaval anastomoses (table 2). The radiologists disagreed more frequently in their interpretations in noncirrhotic and shunted-cirrhotic patients than in cirrhotic patients without portacaval anastomoses (fig. 3). Note also that radiologist A reported the lowest and radiologist B the highest incidence of esophageal varices in each of the subgroups (fig. 3). It is inter-
January 1966
ESOPHAGEAL V.4RICES BALLOON TAMPO NA DE
31
FIG. 2. On the left, a spot film of the distal esophagus taken during conventional barium contrast examination, shows no varices. On the right, during balloon tamponade, the spot film shows a pattern suggestive of esophageal varices in the te rminal esophagus.
esting that radiologist C in radiological interpretation I also made the diagnosis of esophageal varices (combined examination) more frequently than his colleagues (fig. 4). In that preliminary series of interpretations, which was carried out 4 months earlier, radiologist B, not A, reported the lowest incidence of varices in each of the three subgroups of patients. This difference was caused by a large fluctuation in the number of diagnoses of esophageal varices made by radiologist A in the two interpretations, rather than any significant change in the number of varices reported by radiologist B, whose diagnoses were quite consistent in the two series of readings (table 2). Comparison oj conventional esophagograms with balloon tamponade examinations. Esophageal varices were reported by the three radiologists by conventional examination in 31 (25%), 48 (39%), and 37 (30%), respectively, and by combined ex-
amination in 40 (33 %), 57 (47%), and 72 (59%), respectively, (fig. 4). Each radiologist reported a higher incidence of esophageal varices by balloon tamponade examination than by conventional esophagogram. The diagnoses made on conventional examination agreed with those on balloon tamponade in 310 of the 366 interpretations (85%) by the three radiologists. The diagnosis of "no esophageal varices" on conventional examination was changed to "esophageal varices" on the basis of the balloon t amponade examination on 53 occasions in 43 patients. Radiologist A made this change in diagnosis on nine occasions (7%), radiologist B on nine occasions (7%), and radiologist C on 35 occasions (29 %) (table 3). All three radiologists agreed that in two of these patients (nos. 15, 32) esophageal varices, which were not evident on the conventional esophagogram, were present after balloon tamponade of the esophagus. In six additional patients
No.
12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
10 11
9
2 3 4 5 6 7 8
I
---
Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis L aennec's cirrhosis, PCS L aen nec's cirrhosis Hemochromatosis Laennec 's cirrhosis, carcinoma of pancreas Laennec's cirrhosis, PCS L aennec's cirrhosis, SRS Laen nec's cirrhosis, PCS Laennec's cirrhosis Hemochromatosis Laennec 's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis Hypogammaglobulinemia Laennec's cirrhosis L aennec's cirrhosis , PCS Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis, PCS Laennec's cirrhosis, P CS Congestive heart fa ilure Laennec's cirrhosis Congestive heart failure Laennec's cirrhosis
-
0 + + 0 + 0 0 0 0 + 0 + 0 + 0 + + 0 0 0 0 0 0 0 0
+ 0 + 0 0 0
+b
E -
-
+ + + 0 + 0 0 + 0 + 0 0 0 + 0 + + + + 0 + 0 + 0 +
Dc 0 + 0 0 + 0
-
X
0/ 0 0/ 0 + /0 0 /0 0/0 0/0 +/+ 0/ + 0/ 0 +/+ 0/0 0/0 0/0 0/ + 0 /0 + /+ +/+ +/+ 0/0 0/ 0 0/ + 0/ 0 +/+ 0/0 0/+
O/()d 0/0 0/0 0/0 0/ 0 +/+ 0/0 +/+ +/+ +/+ 0/ 0 0/0 0/0 +/+ 0/ + 0/ 0 0/ + 0/ 0 0/0 0/0 + /+ 0/ 0 +/+ 0/ 0 +/+ 0/0 0/ 0 + /+ 0 /0 +/+ 0/0 0/+
0/0 0/0 0/0 +/+ 0/0 +/+ 0/ 0
All BII - -- - - -
+/+ +/+ +/+ 0 /0 0/0 0/0 +/+ 0/+ 0/ + 0/ + 0/0 0/0 0/+ +/+ +/+ +/+ +/+ +/+ +/+ 0/ + +/+ 0/ + +/+ 0/0 0/+
0/+ 0/+ +/+ + /+ 0 /0 +/+ 0/0
CIl
74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94
73
72
71
66 67 68 69 70
64 65
62 63
No.
-
- -
Laennec 's cirrhosis Postnecrot ic cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis, PCS Laennec's cirrhosis Laennec's cirrhosis, PCS Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis, PCS Laennec 's cirrhosis Hemochromatosis Laennec 's cirrhosis Laennec 's cirrhosis Postnecrotic cirrhosis Laennec's cirrhosis, PCS Laennec's cirrhosis Laennec's cirrhosis, PCS Laennec's cirrhosis Laennec 's cirrhosis, PCS Laennec 's cirrhosis Laennec 's cirrhosis, PCS Laennec 's cirrhosis , PCS Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Gastric ulcer Laennec's cirrhosis
Diagnosis
0 0 0 0 + 0 0 + 0 0 0 + + + 0 0 0 + 0 0 0 + 0 + 0 + 0 0 + 0 0 0 +
E
0 + 0 0 + 0 0 + 0 0 0 0 0 + 0 0 0 0 0 0 0 + + + 0 + + 0 0 0 0 0 0
X
0/0 +/+ 0/ 0 0/ 0 + /+ 0/0 0/0 +/+ 0/ 0 0/ 0 0/ 0 0/ 0 0/+ 0/0 0/ 0 0/ 0 0/ 0 +/+ 0/0 0/0 0 /0 0/ 0 0/ 0 0/ 0 0/0 +/+ 0/ + 0/ 0 0/ 0 0/ + 0/0 0/0 0/ 0
All
- - - - - --
1. Comparison of esophagoscopic (E), fluoroscopic-radiological (X), and radiological (All, BIl, CIl) di agnoses of esophageal varices
DiagnosisG
TABLE
-
0/0 0/0 0/0 0/ 0 0/ + 0/ 0 0/0 +/+ 0/0 0/ 0 0/ 0 0/ 0 +/+ 0/0 0/0 0/ 0 +/+ +/+ 0/0 0/0 +/+ +/+ +/+ +/+ +/+ +/+ 0/0 0/ 0 +/+ 0/0 0/ 0 0/0 0/0
BIl --
ClI
- - 0/0 0/ 0 0/ 0 0/ 0 0/ + 0/+ +/+ +/+ 0/ + 0/ 0 0/0 0/0 +/+ +/+ 0/ + 0/ 0 0/ 0 +/+ 0/0 0/0 0/0 0/ 0 0/ 0 +/+ 0/0 +/+ 0/ + 0/ 0 0/0 0/ + 0/0 0/0 0/ 0
t:tJ
......
~
~
~
~
;...
'-3
8 ~
W t-:l
=
+
pes
b
=
---
a
--
Laennec 's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec's cirrhosis Portal vein t hrombosis Laennec's cirrhosis Laennec's cirrhosis L aennec's cirrhosis Laennec 's cirrhosis, pes Duodenal ulcer Laennec's cirrhosis, pes Laennec's ci rrhosis Laennec's cirrhosis Fatty liver Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis, pes Laen nec's cirrhosis Laennec's cirrhosis F atty liver Laennec's cirrhos is Achlorhydria Laennec's cirrhosis Laennec's cirrhosis Laennec 's cirrhosis Laennec 's cirrhosis Fatty liver Laennec's cirrhosis F atty liver
+ + + + + 0 + + 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 + 0 0 0 0 + + + + 0 + 0 0 0 + 0 0 + 0 + 0 0 0 0 0 0 + 0 0 + 0 + 0 0 0
+/+ +/+ +/+ 0/ 0 +/+ 0/0 0/0 + /0 0/0 0/0 0/0 +/+ 0/ 0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/+ 0/0 0/0 +/+ 0/0 +/+ 0/0 0/0 0/0 +/+ +/+ + /+ 0/0 + /+ 0/ 0 0/ 0 +/+ 0/0 0/0 0/0 0/0 0/ + + /+ 0/0 +/+ + /+ 0/0 0/ 0 +/+ 0/+ 0/0 0/0 + /+ 0/+ +/+ 0/0 0/0 0/0
+/+ +/+ +/+ 0/ 0 +/+ 0/0 0/0 +/+ 0/ + 0/ + 0/0 0/ + 0/ 0 0/0 0/ 0 0/ + +/+ 0/+ 0/0 0/+ 0/ 0 0/ 0 0/ + +/+ 0/ 0 0/ + 0/0 0/ 0 I 0/ 0
95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 Laennec's cirrhosis Laennec's cirrhosis Postnecrotic c irrhosis, pes Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis, pes Laennec's cirrhosis Laennec's cirrhosis , pes Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis, pes Laennec's cirrhosis Laennec 's cirrhosis Postnecrotic cirrhosis, pes Laennec's cirr hosis Laennec's cirrhosis, pes Laennec's cirrhosis, pes Laennec's cirrhosis Postnecrotic cirrhosis Laennec's cirrhosis , pes Laennec's cirrhosis Laennec's ci rrhosis Laennec's cirrhosis, pes Laennec 's cirrhosis Laennec's cirrhosis Laennec's cirrhosis Laennec's cirrhosis
0 0 0 + 0 0 0 + 0 + 0 0 + 0 0 0 0 0 0 + + + + 0 0 + + + + + 0 + + 0 0 + + 0 0 0 + 0 + + 0 + + 0 + + + 0 0 + + + +/+ +/+
+1+
0/ 0 + /+ 0/ 0 0/ 0 0/ 0 0/0 0/0 +/+ + /+ +/+ 0/ 0 0/0 +/+ 0/ 0 0/ 0 0/ 0 0/ 0 +/+ 0/0 0/ 0 +/+ 0/ 0 0/+ 0/0 0/0
0 /0 + /+ 0 /0 0 /0 0/0 +/+ +/+ +/+ 0/ 0 +/+ 0 /0 +/+ +/+ +/+ 0/+ 0 /0 0 /0 +/+ 0/0 +/+ + /+ 0 /0 0/ 0 +/+ 0/ + +/+ +/+ + /+ 0/ + +/+ 0/+ +/+ 0/0 0/ + 0/+ +/+ 0/+ +/+ 0/0 + /0 0/+ 0/0 0/0 0/+ 0/0 +/+ 0/0 0/ + 0/ + 0/0 0/ + 0/ + 0/ 0 +/+ 0/+ +/+
Portacaval shunt ; SRS = splenorenal shunt. Esophageal varices. c O = No esophageal varices . d The symbol above the diagonal line represents the diagnosis by conventional esophagogram an d t he symbol below represents t he final diagnosis based on conventional plus balloon tamponade examination.
-
57 58 59 60 61
56
33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55
CA:l CA:l
~ ~
6
~
~
~
o
8
t.-<
~
"-l
~
~
~
~t.-<
~
~'"i:I
~
<0
~ ......
I
"-<
34
CONN ET AL. T.\BLE
Vol. 50, No.1
2. Summary of diagnoses by individual observers Cirrhotic patients
Examination
Esophagoscopic Fluoroscopic-Radiological Radiological I Radiologist A Radiologist B Radiologist C Radiological II Radiologist A Radiologist B Radiologist C
Without portacaval anastomoses (84)
With portacaval anastomoses (27)
Esophageal varices
Esophageal varices
N oncirrhotic patients (11)
Total group (122)
Esophageal varices
Esophageal varices
no.
%
no.
%
no.
%
no.
%
36 40
43 48
3
11
27 18
42 52
34 43
46 40 62 33 41 49
10
37
3 2
55 48 74
12 19
44 37 70
6 4 5
55 36 45
64 54 86
52 44 70
39 49 58
6 13 18
22 48 67
1 3 5
9 27 45
40 57 72
33 47 59
10
I
125
100
NUMBER
OF PATIENTS
ESOPHAGOSCOPIC
ESOPHAGEAL VARICES NO ESOPHAGEAL VARICES
n
n
FLUOROSCOPIC RADIOLOGIC RADIOLOGIC RADIOLOGIC RADIOLOGIC A B C
l~ WHOLE
SERIES
I CIR~HOSIS I
n
CIRRHOSIS C PORTOCAVAL ANASTOMOSIS
FIG. 3. Frequency of diagnosis of esophageal varices by various diagnostic techniques. Each set of four bars shows from left to right the total series of patients, cirrhotic patients without portacaval anastomoses, cirrhotic patients with portacaval anastomoses, and the noncirrhotic patients. The height of the bars shows the number of patients. The upper portion of each bar, unshaded, or cross-hatched, shows the number without esophageal varices. The lower, black portion of each bar indicates the number with esophageal varices.
(nos. 17, 53, 66, 88, 91, 117), two of the three radiologists made similar observations. In the other 35 patients only one of the three radiologists believed that the balloon examination alone demonstrated esophageal varices, and almost all of these
were so interpreted by radiologist C. In three patients one of the radiologists thought that balloon tamponade obscured esophageal varices which were apparently present on conventional examination. Diagnostic validity of radiological inter-
ESOPHAGEAL VARICES BALLOON TAMPONADE
January 1966
125 100
NUMBER
75
OF PATIENTS 50
I
25
O~·IU.nL-~I~~nL---I~n~----~I~n~~~I~n~~~I~nLRADIOLOGIST
B
A
CAB
CONVENTIONAL ESOPHAGOGRAM
C
COMBINED EXAMINATION
FIG. 4. Comparison of diagnoses of esophageal varices by conventional and balloon tamponade examinations. On radiological interpretations I and II the height of the bars represents the number of patients examined. The lower, black portion of each bar shows the patients with esophageal varices; the upper, unshaded portion those without esophageal varices.
pretation. The radiologists agreed with each other in 258 of the 366 paired interpretations of the 122 complete radiological examinations (70%) (table 4). The interobserver error, which was based on 108 diagnostic disagreements in 366 pairs of interpretations (30%), ranged from 25 to 34% for the three pairs of radiologists. Interobserver error was lower (20 to 24%; mean, 21 %) when the radiological examinations were based on conventional esophagograms alone; i.e. excluding balloon tamponade examinations (table 4). Furthermore, the three radiologists unaninously agreed on the radiological diagnosis based on conventional esophagograms in 83 of the 122 patients (69%), but in only 68 of the 122 patients (56%) based on combined examinations. 3. Influence of esophageal tamponade on the radiological diagnosis of esophageal varices
TABLE
No varices No varices Varices by byesophag- byesophag- esophagogramU ograma ogramU
Varices by esophagograma
No varices by balloon tamponade
Varices by baJloon tamponade
No varices by baJloon tamponade
Varices by baJloon tamponade
82 65 50
9 9 35
2 0 1
29 48 36
Radiologist
A B C a
Conventional esophagogram.
TABLE
4. Observer variation in the radiological diagnosis of esophageal varices
I Complete radiological examination a
Conventional esophagogram Radiologis ts
Diagnostic Diagnostic Diagnostic Diagnostic agreement disagree- agreement disagreement ment
no.
I nterobserver variation A vs. B 93 A vs. C 98 Bvs.'C 97 Total 288 Intraobserver variation Avs. A B vs. B C vs. C Total
%
no.
%
%
no.
I
%
I
I
76 80 80 79
29 24 25 78
24 91 75 31 I 20 86 70 36 20 81 66 41 21 258 70 108
25 30 34 30
I
I
100 113 100 313
82 93 82 86
22 9 22 53
18 92 7 108 18 93 i4 293
75 89 76 80
Conventional esophagogram plus tamponade examination. a
no.
30 14 29 73
25 11
I
24 20
balloon
Decreased diagnostic reliability for the balloon tamponade examinations was also found in comparing the radiological interpretations of the three radiologists with their own prior diagnoses (intraobserver error). Based on the combined radiological
36
Vol. 50, No.1
CONN ET AL. 5. Comparison of esophagoscopic and radiological diagnosis of esophageal varices
TABLE
Agreement between esophagoscopic and radiological diagnoses Radiological examina tion
Fluoroscopicradiological Radiological interpretation I Radiologist A Radiologist B Radiologist C Total Radiological interpretation II Radiologist A Radiologist B Radiologist C Total
Conventional barium contrast examina tion
Combined conventional plus balloon tamponade examina tions
no.
%
68 73 70 70
78 82 62 222
64 67 51 61
75 69
88 79
72 65
73 72
239
no.
%
82
67
83 89 86 258
92 84 89 265
72
59 65
examination, they disagreed with their earlier diagnoses in 25,11, and 24%, respectively (mean, 20%) (table 4). Intraobserver variation, based on conventional radiological examination, was 18, 7, and 18%, respectively (mean, 14%) for the three radiologists (table 4). Comparison of esophagoscopic and radiological interpretation II. Radiological interpretation of the conventional examinations by the three radiologists agreed with the esophagoscopic diagnosis in 75, 69, and 73%, respectively (table 5). Diagnostic agreement between the conventional radiological and the endoscopic interpretations was higher than between the balloon tamponade and the endoscopic findings for each of the three radiologists (72, 65, and 59%, respectively, table 5). A similar pattern was observed in the mdiological interpretation I in which the diagnosis of esophageal varices by routine esophagogram agreed with the endoscopic diagnosis more frequently than did the balloon esophagogram (table 5). Esophageal varices were reported by the esophagoscopist in only 11 of the 43 patients (26%), in whom esophageal varices were diagnosed by balloon tamponade but not by the conventional esophagogram.
Neither of the two patients (nos. 15, 32) in whom balloon tamponade unanimously resulted in a diagnosis of esophageal varices had varices by esophagoscopy. Thus, the endoscopic-radiological agreement was much lower than anticipated in those instances in which the diagnosis of varices was based solely on balloon tamponade. Although it is not known which of these techniques was correct in individual patients, the failure of the radiologists to confirm each other in the large majority of those instances in which the diagnosis of esophageal varices was based on the balloon tamponade examination, however, casts doubt on the accuracy of the balloon technique. Furthermore, the endoscopic diagnosis concurred with the unanimous conventional radiological diagnosis in 69 of the 83 patients (83 %) in whom the three radiologists agreed, but agreed in only 66 of the 117 nonunanimous interpretations (56%). This difference was highly significant stastistically (P < 0.001). Similarly, esophagoscopic agreement with radiological diagnoses based on combined examination occurred in 51 of the 68 unanimous diagnoses (75%), but in only 89 of the 162 nonunanimous radiological interpretations (55%). This difference, too was highly significant (P < 0.001). Discussion
Clinical diagnosis of esophageal varices. Investigation of the accuracy of the diagnosis of esophageal varices is limited by the difficulty of determining with certainty whether or not esophageal varices are present in a given patient. The present study, which was undertaken to evaluate the role of balloon tamponade in the radiological diagnosis of varices, is thus hindered by the very inadequacies it seeks to correct. Each of the techniques currently used for the diagnosis of esophageal varices is limited by intrinsic deficiencies of the method, by observer variation, or both. The validity of barium contrast examination of the esophagus, which is the standard method of demonstrating esophageal varices, has recently been questioned. 4 - 6 Esophagoscopy, which is a more difficult and potentially more dangerous procedure than the barium
January 1966
ESOPHAGEAL VARICES BALLOON TAMPONADE
esophagogram, is also hindered by observer variability.7. 15 In addition, it has been reported that esophageal varices seen on one esophagoscopic examination may sometimes disappear and reappear without great change in the patient's clinical state. 16. 17 Whether such observations represent observer variation or fluctuation in portal hemodynamics is unknown , however. Splenoportography, which is a more difficult and hazardous diagnostic procedure, can also be used to demonstrate esophageal varices.8-10 Disagreements between the splenoportographic findings and the results of other diagnostic techniques occur, however.11-13.18-20 It is also uncertain whether collateral vessels seen to flow toward the esophagus during splenoportography represent true submucosal varices of the esophagus which may bleed massively, or periesophageal veins which are not a serious threat to the patient. B• 2o Although no controlled investigation of splenoportography in the diagnosis of esophageal varices has yet been reported, it is probable that observer variability of similar magnitude exists in the interpretation of splenoportograms. Although the diagnosis of esophageal varices has been made with certainty at esophagotomy,21 such surgery cannot be justified solely for diagnostic purposes, and can only serve as an occasional means of diagnostic confirmation. Even postmortem findings cannot be used as proof of the presence or absence of esophageal varices at some earlier time. 22 . 23 Since the presence or absence of esophageal varices cannot be established unequivocally, the data in the present study were necessarily based on clinical observations. The esophagoscopic diagnosis was employed, not as an absolute index of the presence or absence of esophageal varices but as a relative point of reference. Obse1'ver variation. Since both the radiological and the endoscopic diagnosis of esophageal varices are subjective interpretations, the degree of observer variability must be considered in assessing the diagnostic accuracy of balloon tamponade. Observer variation in medicine may be defined as disparities in the diagnosis of the
37
presence, absence, or degree of an abnormality based on serial interpretations of clinical history, physical examination, roentgenograms, histological slides, or other clinical or laboratory data. Differences between observers are known as interobserver variation and between serial interpretations by the same observer as intraobserver variation. Interobserver error has ranged from 20 to 35% in a variety of investigations and intraobserver error from 15 to 25%.24. 25 Factors responsible for observer variation include the skill and experience of the observers, the nature of the judgment required, the technical quality of the examination, and the conditions of interpretation, as well as the personality and motivation of the observers. In this study the observers were highly skilled, experienced radiologists. They were required to decide simply whether or not esophageal varices were present, but not to grade the magnitude of the varices. Technically inadequate films had been excluded by the participants during a preliminary interpretation of the films. Roentgenograms were read in groups of lO examinations or less under conditions selected by the individual radiologists, all of whom had volunteered to participate. Despite these measures, observer variation of considerable magnitude was encountered. The three radiologists disagreed with each other in approximately 20% of conventional esophagograms and with their own prior interpretations in about 15%. This degree of observer error is in accord with previous estimates in the diagnosis of esophageal varices,6 chest roentgenograms,26. 27 abdominal films,28 and other diagnostic techniques,24.25 A higher incidence of both inter- and intraobserver error was noted in the interpretation of balloon tamponade examinations (28 and 20%, respectively), The higher incidence of observer variation (P < 0.05) with balloon tamponade than with conventional examinations was observed in each of the three radiologists, These observations indicate that the criteria for the diagnosis of esophageal varices not only differ among radiologists, but may change greatly in individual radiologists over relatively short periods of
38
CONN ET AL.
Vol. 50, No.1
time. In addition, they suggest that the of balloon tamponade were not erroneous. criteria for the interpretation of esophag- Perhaps inflation of the esophageal balloon {)al varices by balloon tamponade exami- made visible small esophageal varices nation are less precisely defined than for the which were not evident on conventional more familiar conventional esophagogram. radiological examination. The lack of Comparison of endoscopic and radiolog- agreement among the three radiologists in ical diagnoses. The endoscopic diagnosis of these instances argues strongly against this esophageal varices agreed with conven- hypothesis. It is more likely that the prestional radiological diagnosis in approxi- ence of the balloon in the esophagus caused mately three-fourths of the examinations. artifacts compatible with esophageal varThese findings confirm previous observa- ices. We observed, for example, that the intions of esophagoscopic-radiological agree- flated balloon induced active propulsive ment in the diagnosis of esophageal var- peristalsis and, frequently, tertiary contracices. 6. 7 Inclusion of balloon tamponade tions which sometimes simulated esophagexaminations, however, resulted in a lower eal varices. It is also probable that subincidence of radiological-endoscopic agree- conscious bias in favor of the diagnostic ment, i.e. less than two-thirds of the ex- value of balloon tamponade may have aminations. The incidence of discordant caused overenthusiastic interpretation of endoscopic-radiological diagnoses (25 to esophageal varices. Although all three 31 %) was only slightly higher than the radiologists reported esophageal varices frequency of disagreement among radiolo- more frequently by balloon tamponade gists who read the same films (19 to 24%),6 than by conventional examination, one of and not appreciably different from the in- the radiologists (C) made such diagnoses cidence of disagreement between esophagos- on 35 occasions, four times more comcopists who examined cirrhotic patients monly than his colleagues. These 35 interfor esophageal varices during the same pretations alone account for most of the endoscopic examination (33%).7.15 These discrepancies observed between the conobservations suggest that the effect of ventional and balloon tamponade examinaobserver variation alone would result in tions. discordant diagnoses between endoscopic Incidence of esophageal varices in cirand radiological techniques in more than rhosis. Esophageal varices were observed one-fourth of patients examined. Conse- in cirrhotic patients (excluding cirrhotic quently, one must expect disagreements be- patients with portacaval anastomoses) in tween two diagnostic techniques at least this study by esophagoscopy in 43%, by as frequently as the incidence of observer fluoroscopic-radiological examination in variation inherent in the techniques em- 48%, and by conventional esophagograms ployed. in 35% (30 to 42%) (fig. 5). Although these Effect of balloon tamponade examination findings confirm the radiological and enon the radiological diagnosis of esophageal doscopic incidence of varices found in cirvarices. Balloon tamponade appeared to rhosis in this laboratory,6. 7. 15 and elsediminish both the diagnostic accuracy and where,2. 30. 31 they are at variance with other validity of conventional barium contrast reports. Brick,5 Sullivan and Myers,29 and examination of the esophagus. This was Greene et al.,13 have reported higher intrue for diagnostic agreement of each of the cidences of esophageal varices in cirrhosis three radiologists with the endoscopic diag- by esophagoscopy (73 to 90%) and Friednoses, with the fluoroscopic-radiological berg et aU a lower incidence (30%). They diagnoses, with each other's radiological also found a lower incidence (24 to 28%) of diagnoses and with their own previous esophageal varices radiologically,4. 5. 29 than was found by us or other authors.2. 30. 31 radiological diagnoses. What is the explanation for the apparent These observations suggest that differences deleterious effect of balloon tamponade on in criteria for both the endoscopic and rathe radiological diagnosis of esophageal diological diagnosis of esophageal varices, varices? It is conceivable that the findings as well as differences in the selection of pa-
January,1966
ESOPHAGEAL VARICES BALLOON TAMPONADE
39
ESOPHAGEAL VARICES
in percent
o ESOPHAGOSCOPY
FLUOROSCOPIC RAOIOLOGIC
ABC CONVENTIONAL RADIOLOGIC EXAMINATION
FIG. 5. Incidence of esophageal varices in cirrhosis. The lower, black portion of each bar represents the percentage of patients reported to ha ve esophageal varices, and the upper, unshaded portion the percentage without varices.
tients, probably account for the various results of different investigators. . Comments. Balloon tamponade in our hands decreased both the diagnostic accuracy and reliability of the conventional radiological diagnosis of esophageal varices. Furthermore, this investigation did not establish the diagnostic superiority of either esophagoscopy or conventional barium contrast examinations. These findings demonstrate the potential dangers of observer variability in clinical investigations and emphasize the necessity of designing such investigations to minimize the effects of observer error. Although each of these methods is susceptible to the errors of subjective interpretation, diagnostic agreement by both techniques minimizes the incidence of observer error and provides dependable evidence of the presence or absence of esophageal varices. In patients in whom the radiological and endoscopic methods fail to agree, however, further diagnostic efforts are mandatory. These include careful re-examination by the conventional radiological technique,30. 31 with interpretation by several radiologists, and by esophagoscopy with evaluation by several endoscopists if possible. In addition, other m ethods such as splenoportography, measurement of splenic pulp pressure, or evaluation of ammonia tolerance 32 may be helpful in arriving at the correct diagnosis. The necessity of employing multiple methods emphasizes the need for an accurate and reliable technique for the diagnosis of esophageal varices.
SUInmary This investigation was undertaken to evaluate the accuracy and reliability of balloon tamponade of the esophagus as an adjunct to the radiological diagnosis of esophageal varices. One hundred twentytwo patients, including 111 with cirrhosis, were studied successively by conventional barium contrast examination, by balloon tamponade examination, and by esophagoscopy. Three radiologists independently interpreted the conventional esophagograms alone and in conjunction with the balloon tamponade examination. Esophageal varices were found in 25 to 39% of the patients by conventional esophagogram, in 33 to 59% by the combined radiological interpretation, and in 34% by esophagoscopy. The incidences of both inter- and intraobserver error were lower with conventional than with balloon tamponade radiological examination. Similarly, diagnostic agreement of endoscopic findings was higher with conventional than with balloon tamponade examination. Balloon tamponade examination not only failed to improve the radiological diagnosis of esophageal varices but it appeared to decrease the accuracy and reliability of the radiological diagnosis of esophageal varices. The importance of designing such investigations to minimize observer variation was emphasized. REFERENCES 1. Ritvo, M., and 1. A. Shauffer. 1952. Gastrointestinal x-ray diagnosis, p. 838. Lea & Febiger, Philadelphia.
40
CONN ET AL.
2. Evans, K. T. 1959. Accuracy of examination of
the esophagus with barium in the diagnosis of esophageal and gastric varices. Brit. J. Radiol. 32: 233-240. 3. Evans, J. A., and M. A. Payne. 1958. Studies of esophageal varices before and after portacaval shunts. ArneI'. J. Roentgen. 79: 760767. 4. Friedberg, S. A., H. D. Bennett, H. Singh, and J. Lindberg. 1955. Esophageal varices in hepatic cirrhosis. An endoscopic study. Ann. Otol. 64: 599-608. 5. Brick, 1. B. 1961. Esophagoscopy by and for the internist: A review of results in a thousand patients. Amer. J. Med. Sci. 241: 289-294. 6. Conn, H. 0., J. R. Mitchell, and M. G. Brodoff. 1961. A comparison of radiologic and esophagoscopic diagnosis of esophageal varices. New Eng. J. Med. 265: 160-164. 7. Conn, H. 0., H . Smith , and M. Brodoff. 1965. Observer variation in the diagnosis of esophageal varices by esophagoscopy. New Eng. J. Med. 272: 830-834. 8. Atkinson, M., E. Barnett, S. Sherlock, and R. E. Steiner. 1955. The clinical investigation of the portal circulation, with special reference to portal venography. Quart. J. Med. 24 : 77-91. 9. DeWeese, M. S., M. M. Figley, W. J. Fry, R. Rapp, and H. L. Smith. 1957. Clinical appraisal of percutaneous splenoportography. Arch. Surg. (Chicago) 75: 423--435. 10. Panke, W. F., E. G. Bradley, A. H. Moreno, F . F. Ruzicka, and L. M. Rousselot. 1959. Techniques, hazards and usefulness of percutaneous splenic portography. J. A. M. A. 169: 1032-1037. 11. Fuld, H., and D. T. Irwin. 1954. Clinical application of portal venography. Brit. Med. J. 1: 312-313. 12. Doppman, J. L., and R. L. Shapiro. 1961. Bleeding esophageal varices in the presence of a normal splenoportogram. Amer. J. Roentgen. 86: 1103-1107. 13. Greene, L ., H . Weisberg, W. S. Rosenthal, P. A. Douvres, and D. Katz. 1965. Evaluation of esophageal varices in liver disease by splenic-pulp manometry, splenoportography and esophagoscopy. Diagnostic discrepancies. Amer. J. Dig. Dis. 10: 284- 292. 14. Nathan, M. H. 1959. Diagnosis of esophageal varices by a new radiologic method. Radiology 73: 725-732. 15. Conn, H . 0., H . W. Smith, and M. Brodoff.
Vol. 50, No.1
1965. Correspondence. New Eng. J. Med. 273 : 1052. 16. Bennett, H. D., C. Lorentzen, and L. A. Baker. 1953. Transient esophageal varices in
hepatic cirrh05is. Arch. Intern. Med. 92: 507-522. 17. Palmer, E. P. 1957. On the natural history of
esophageal varices. Ann. Intern. Med. 47: 18-26. 18. Steiner, R. E., S. Sherlock, and M. D. Turner. 1957. Percutaneous splenic portal venography. J . Fac. Radiol. 8: 158-177. 19. Figley, M. M., W. J. Fry, J. E. Orebaugh, and H. M. Pollard. 1955. P ercutaneous splenoportography. Gastroenterology 28: 153162. 20. Bergstrand, 1., and C. A. Ekman. 1955. Per-
21.
22.
23.
24.
25. 26.
27.
28.
29.
30. 31.
32.
cutaneous Lieno-portal venography. Acta Radiol. (Stockholm) 43: 377-392. Orloff, M. J ., and H. S. Thomas. 1963. Pathogenesis of esophageal varix rupture. Arch. Surg. (Chicago) 87: 301-306. Templeton, F. E. 1964. X-ray examination of the stomach, Rev. Ed., p. 598. University of Chicago Press, Chicago. Hare, H. F., E. Silveus, and F. A. Ruoff. 1948. Esophageal and gastric varices, with report of a case. Surg. Clin. N. Amer. 28: 729-732. Garland, L. H. 1959. Studies on the accuracy of diagnostic procedures. Amer. J. Roentgen. 82: 25-38. Lusted, L. B. 1960. Logical analysis in roentgen diagnosis. Radiology 74: 178-193. Garland, L. H. 1950. On the reliability of roentgen survey procedures. Amer. J. Roentgen. 64: 32--41. Yerushalmy, J. 1955. Reliability of chest radiography in the diagnosis of pulmonary lesions. ArneI'. J. Surg. 89: 231-240. Sloan, R. D. 1959. Roentgenologic evaluation of mesenteric small intestinal obstruction. ArneI'. J. Roentgen. 82: 978-984. Sullivan, B. H., Jr., and J. E. Myers. 1959. Gastroscopy and esophagoscopy: An analysis and discussion of 1752 procedures. Med. Ann. D. C. 28 : 442--446. Schatzki, R. 1940. Roentgen demonstration of esophageal varices; its clinical importance. Arch. Surg. (Chicago) 41: 1084-1100. Nelson, S. W. 1957. Roentgenologic diagnosis of esophageal varices. Amer. J. Roentgen. 77: 599-611. Conn, H. O. 1961. Ammonia tolerance as an index of portal-systemic collateral circulation in cirrhosis. Gastroenterology 41: 97106.