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Limited value of early endoscopy in the management of acute upper gastrointestinal bleeding
Limited Value of Early Endoscopy in the Management of Acute Upper Gastrointestinal Bleeding Prospective Controlled Trial
David Y. Graham, MD, Houston, Texas
Early endoscopy is of proven value in demonstrating the site of bleeding in patients with acute upper gastrointestinal hemorrhage [I]. Endoscopy is also established as a more accurate diagnostic procedure than roentgenography; moreover, it has been suggested that x-rays often provide misleading information [2]. Although endoscopy has become the accepted method of diagnosis in acute upper gastrointestinal hemorrhage, there are no controlled trials that directly answer the question of whether the information obtained by endoscopy significantly influences patient management. Several recent reports [2-61 have suggested that the outcome of a bleeding episode is the same whether or not a patient receives endoscopy or radiology as the initial diagnostic test and whether or not endoscopy is employed early or late in the course of the bleeding episode. The present study was designed to investigate the effect of early endoscopy on the decision-making process in patients with acute upper gastrointestinal hemorrage. The study revealed that, although early endoscopy yields the correct diagnosis in most patients, it has little effect on either the overall management or the eventual outcome of the acute bleeding episode. Methods Fiberoptic upper gastrointestinal endoscopy was performed early in the treatment of consecutive patients adFrom the Department of Medicine, Baylor College of Medicine, and Houston Veterans Administration Medical Center, Houston, Texas. Computational assistance was provided by the CLINFO Project, funded by the Division of Research Resources of the National Institutes of Health under contract NOl-RR-5-2118. Requests for reprints should be addressed to David Y. Graham, MD, Department of Medicine, Veterans Administration Medical Center, 2002 Holcombe Boulevard, Houston, Texas 77211.
284
mitted to Ben Taub General Hospital with acute upper gastrointestinal hemorrhage. Endoscopy was performed after hemodynamic stability and written consent were obtained. In each instance, the referring physician completed a standard questionnaire in which data pertaining to the present and previous bleeding episodes, if any, were listed and the clinical diagnosis and treatment plans were outlined. Each patient was then randomly assigned to one of two groups according to a schedule prepared from a table of random numbers. In one group the results of endoscopy were revealed immediately (the “Tell” group), while in the second group the results were sealed in an envelope placed in the patient’s chart, to be revealed after 4 days (the “No tell” group). The Tell group physicians were allowed to observe the endoscopic procedure; the physicians for the other group were not. After endoscopy the Tell group physicians recorded their opinions as to whether the information obtained was of benefit and whether it prompted any changes in plan. The No tell group was requested to record changes in plan daily for 4 days, at which time the results of endoscopy were revealed. After those results were known changes in plan or therapy were also recorded. No attempt was made to influence the physicians’ management decisions, and the patients were managed as the physicians believed appropriate. The results of the procedure in the No tell group could be disclosed earlier than the scheduled time using the following “escape clauses”: (1) brisk bleeding noted at endoscopy, (2) death or discharge of the patient, (3) a decision to proceed to surgery, and (4) recurrence of major bleeding after a significant therapeutic decision (such as the use of a Blakemore tube). The records of the patients were carefully reviewed to identify unrecorded changes in plan or protocol violations such as early revelation of endoscopy results. Major hemorrhage was defined as a decrease in hematocrit to 30 percent or below, a transfusion of 1,000 ml of blood without a corresponding increase in hematocrit or a decrease in hematocrit of 10 percent or more while under
The American Journal of Surgery
Endoscopy in the Management of Bleeding
TABLE I
TABLE II
Comparison of Historical Features* of Patients
Feature History Ulcert Mallory-Weisst Documented bleeding Undocumented bleeding Transfusions Comorbid diseases Liver Heart Lungs Ethanol use
Tell Group No. Percent+
9No.
Percent
39 12 39 18 22
13 4 12 9 6
28 9 26 20 13
0.6 0.8 0.2 0.9 0.5
12 2 4
24 4 8
13 2 4
28 4 9
0.6 0.9 0.9
Small intake/day None Large intake/day Aspirin use
8 22 19
<3 tablets/day None L3 tablets/day
12 27 10
16 45 39
7 18 21
15 39 I 46
Diagnosis
p>
19 6 19 9 11
0.8
Comparison of Clinical Impression With Actual Bleeding Site Impression Percent * No.
Peptic ulcer Unclassifiedt Duodenal Gastric Marginal Varices Mallory-Weiss Gastritis Esophagitis Aortoduodenal fistula Malignant Unknown
14 35 7 3 13 6 14 1 0 1 1
Total
95
14.7 36.8 7.4 3.2 13.7 6.3 14.7 1.1 . ;:1 1.1 100
Bleeding Site No. Percent 0 25 20 1 19 22 2 0 1 2 3 95
l
263 21.1 1.1 20.0 23.2 2.1 ;:1 2.1 3.1 100
Percent of total cases. t Site not specified. l
24 55 21
8 28 10
17 61 22 I
0.8
Before entry. t Percent of total cases. t Suggested by history. l
observation. Minor hemorrhage was defined as changes less than those noted above. The study was approved by the Human Experimentation Committee at Baylor College of Medicine and Ben Taub General Hospital, Houston, Texas. All patients signed informed consent for endoscopy and for entry into the study. Statistical analysis: Chi-square analysis or Fisher’s exact test was used to test for significance of difference and distribution of patients among various categories. Differences in numerical data for the two groups were compared using the two-tailed Student’s t test. The 5 percent significance level was used throughout.
Results From December 1976 to November 1977, ninetynine patients presenting to the hospital because of acute upper gastrointestinal hemorrhage were entered into the study. Four patients were subsequently excluded after randomization when it was discovered that they did not have acute upper gastrointestinal hemorrhage. The diagnoses in the excluded patients included chronic anemia and bleeding from the gums, the lungs and the colon. There was no difference in the frequency of major hemorrhage (91.6 percent) and minor hemorrhage (8.4 percent; three in the Tell group and five in the No tell group) (p >0.5). Demographic and historical data: There were no significant differences in the groups with regard to age, sex or racial distribution. The patients’ ages ranged from 18 to 77 years, with a mean of 45 (42 f
Volume 140, August lgg0
13, Tell group; 47 f 16, No tell group). There were 19 men and 30 women in the Tell group and 17 men and 29 women in the No tell group, with a racial distribution of 61.6 percent white and 48.4 percent black. There were 49 patients in the Tell group and 46 in the No tell group. There was no difference between groups with respect to the number of patients reporting either a history of abdominal pain suggestive of peptic ulcer disease or a history suggestive of Mallory-Weiss tear (vomiting, retching, coughing, seizure activity) preceding the bleeding episode (Table I). Similarly, there were no significant differences in the number of patients in each group with previous bleeding episodes, transfusions, ethanol or aspirin use, or in the frequency of significant comorbid conditions (Table I).
Comparison of clinical diagnosis with actual bleeding site: A comparison of the frequency of each clinical diagnosis with the frequency of that diagnosis as the actual bleeding site is shown in Table II. The initial diagnostic impression was correct in only 34 instances (36 percent). When duodenal, gastric, marginal and ulcer site not specified were grouped as peptic ulcer, the correct bleeding site was identified in 56 patients (59 percent). The reliability of specific clinical diagnoses was as follows: peptic ulcers were diagnosed 59 times and were correct in 41 cases (69 percent), varices were predicted 13 times and were correct in 10 cases (77 percent), and MalloryWeiss tears were diagnosed only 6 times and were correct in 3 cases (50 percent). In contrast, acute mucosal erosive lesions, esophagitis or gastritis were diagnosed on 15 occasions, and in no instance was that diagnosis correct.
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Graham
TABLE III
Comparison of Bleeding Sites in the Two Groups
Diagnosis
12 11 1 10 10 1 1 0 3
Total
49
l
No.
Percent
24.5 22.4 2.0 20.4 20.4 2.0 2.0
13 9 0 9 12 1 1
28.3 19.6 ;9:6 26.1 2.2 2.4
.6:1
01
2.2
100
46
Group *
Outcome
l
Tell
Duration of hospitalization (days) Time to Achieve diagnosis (hr) Start antacids (days) Start oral feeding (days) Start regular diet (days) Operations No. of cases Days from entry Emergency Elective Recurrence of bleeding No. of cases Days from entry Deaths No. Days from entry
100
Percent of total cases.
There was no statistical difference in the distribution of bleeding sites in the two groups (p >0.8) (Table III). Although there were approximately equal numbers of patients with bleeding esophageal varices in each group, the No tell group was slightly skewed (p <0.05) toward more severely ill patients as indicated by the hepatic functional reserve (Child’s criteria) [ 71. The Tell group had the following number of patients in each of the Child’s groups: A, two; B, five; and C, three. In the No tell group the distributions were A, one; B, one; and C, seven. Value of barium upper gastrointestinal x-rays: Upper gastrointestinal series were obtained in only 51 patients (53.7 percent), and there was no difference in the groups in the frequency of performance of barium x-ray examinations. Even when performed, x-rays had a poor diagnostic yield in that 59 percent were interpreted as normal and 15 percent as demonstrating nonspecific abnormalities such as irritable duodenum. Fourteen patients with duodenal ulcer
TABLE V
Effect of Knowledge of Endoscopy Results on Outcome
No Tell Group
Tell Group Percent* No.
Peptic ulcer Duodenal Gastric Marginal Varices Mallory-Weiss tear Gastritis Malignancy Aortoduodenal fistula Unknown
TABLE IV
No Tell
11.3 f
10
12.2 f
6.0 f 5 0.2 f 0.7 l.Of 1 2.3 f 2 11 5.0 f 5 6 5 5 2.2 f
1
4 22 f 22
p>
15
8.9 f 13+ 0.4 f 1 l.Of 1 2.1 f2 7 16.8 f 21 ;
0.30
0.14 0.30 0.30 0.30 0.63 0.18
}
0.63
10 7.8 f
15
0.11 0.26
6 13.7 f
16
0.55 0.61
Mean f standard deviation + Coded and not revealed. l
had an upper gastrointestinal series, and the correct diagnosis was obtained in 8. The lesions were identified by x-rays in 7 of 13 patients with gastric ulcer. Effect of knowledge of endoscopic results on outcome: There were no significant differences in the groups with respect to duration of hospitalization, time (hours) to achieve correct diagnosis or length of time (days) before instituting antacid therapy, oral feedings or regular diet (Table IV). In addition, there were no differences in the number of patients who had operation, recurrence of bleeding or death (Table V) or in the number of transfusions administered (Tell 4.2 f 0.6, No tell 3.4 f 0.5: p >0.3). Effect of endoscopy on diagnostic plan or therapy: The diagnostic plan or therapy was not
Summary of Patient Deaths
Bleeding Site Duodenal ulcer Varices Varicest Aortoduodenal fistula Varicesf Gastric ulcer Varices Mallory-Weiss tear+ Varices Duodenal ulcer+
Day of Death l
Surgery
0
.
1 2 3 5 11 32 32 35 49
. Emergency Emergency
. Elective Elective Emergency
Rebleeding
Cause of Death
Yes Yes No Yes Yes No Yes No Yes No
Bleeding Bleeding Respiratory failure+ Bleeding Sepsis Respiratory failure+ Hepatic Failure Sepsis Hepatic Failure Sepsis
Day(s) after entry. t Patient in the Tell group. f Adult respiratory distress syndrome. l
266
The American Journal of Surgery
Endoscopy in the Management
changed in 74 (78 percent) of patients after the endoscopic diagnosis was revealed. There was a change in plan in 11 patients in the Tell group and 10 in the No tell group (Table V). The change of plan was considered important in only 11 (12 percent) of the patients, 6 of whom were bleeding briskly at the time of endoscopy, 4 from esophageal varices and 2 from peptic ulcer disease. Protocol violation manifested by inappropriate or early examination of the diagnosis was evident in only nine patients; the reasons given for violation ranged from a staff physician or surgeon wanting to know to disagreement in principle with the study. The only instance in which a protocol violation resulted in a significant change in either treatment or diagnostic plan was one that was not in the best interest of the patient (patient 16, Table VI). In that patient a nonbleeding gastric ulcer was treated with intravenous vasopressin and cimetidine. The bleeding sites in patients in whom protocol violations occurred were peptic ulcer disease in four, MalloryWeiss tear in two and esophageal varices in two. Most patients stopped bleeding either before or soon after coming to the hospital and brisk bleeding was noted at endoscopy in only 14 patients, 6 in the No tell group (ulcers, 3; varices, 3) and 8 in the Tell group (ulcers, 5; varices, 2; Mallory-Weiss tear, 1). Three of the briskly bleeding patients had emergency
TABLE VI
of Bleeding
surgery, and peptic ulcer was the site of bleeding in all three. Of the remaining 11 patients admitted with active bleeding, 4 (3 with varices and 1 with duodenal ulcer) had an episode of rebleeding. Recurrence of bleeding was uncommon. Only 15 (13 percent) of the patients not bleeding briskly on admission had a major episode of rebleeding with 8 (53 percent) having rebleeding within 48 hours. The bleeding sites in this group included esophageal varix, eight patients; duodenal ulcer, gastric ulcer and MalloryWeiss tear, two each, and aortoduodenal fistula, one. There was no statistical difference in the frequency with which the escape clause was used in the No tell group (six) and the frequency with which it would have been required in the Tell group (eight). The results of endoscopy were considered helpful by the involved physicians in only about one half of the cases: 51.1 percent in the Tell group and 53.3 percent in the No tell group (p >0.7). Deaths: The bleeding sites in the 10 patients who died included esophageal varices in 5; duodenal ulcer in 2; and Mallory-Weiss tear, gastric ulcer and aortoduodenal fistula in 1 each. Only three deaths were directly attributable to bleeding. The other deaths were related to the underlying disease or were complications of operation (Table V). Complications of endoscopy: There were no serious complications attributable to the endoscopic
Summary of Patients in Whom a Change In Plan Occurred After the Results of Endoscopy Were Revealed
Case
Bleeding
No.
Site
Initial impression
1 2’ 3 4’
Varices Varices Varices Varices
Gastritis Varices Gastric ulcer Varices
5’ 6 7’ 8’ 9 10 11’
Varices Varices Varices Varices Varices Varices Varices
Gastritis Gastritis Malignancy Peptic ulcer Varices Varices Varices
12’ 13’ 14’ 15
Peptic Peptic Peptic Peptic
Peptic ulcer Peptic ulcer Peptic ulcer Mallory-Weiss
16 17’ 18
Peptic ulcer Mallory-Weiss Mallory-Weiss
Gastritis Gastritis Peptic ulcer
19 20 21
Mallory-Weiss Malignancy Peptic ulcer
Varices Peptic ulcer Peptic ulcer
ulcer ulcer ulcer ulcer
Active Bleeding
+ + +
+
Result of Change in Plan
Importance of Change
Vasopressin given Vasopressin given Vasopressin given Used Sengstaken-Blakemore tube instead of angiogram with vasopressin Vasopressin given No antacid given Liver biopsy done Discontinued barium enema Discontinued upper gastrointestinal series Discontinued upper gastrointestinal series Postshunt patient: later obtained elective angiogram for shunt patency Elective surgery planned Outlet obstruction found and treatment begun Discontinued upper gastrointestinal series Active bleeding; decided on surgery; changed to intraarterial vasopressin when diagnosis known Intravenous vasopressin and cimetidine begun Discontinued Maalox Rebleeding; surgeon decided not to operate when diagnosis known Told surgeon consult not needed Plan to operate, elective Immediate surgery
+ + + +
+ + + + +
* Patient in the Tell group.
Volume 140, August 1960
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Graham
procedure. Whether the procedure itself was deleterious (restarting bleeding, for example) cannot be ascertained from this study because almost all of the patients underwent endoscopy. In two uncooperative patients, endoscopy could not be performed. One of them had a classic history for Mallory-Weiss tear and normal findings on barium examination. The other patient had been asymptomatic before bleeding and had normal findings on x-ray examination. Another patient had a history consistent with Mallory-Weiss tear, but no tear was seen at endoscopy; the upper gastrointestinal x-rays were normal and endoscopy was not repeated. Two patients underwent endoscopy twice in the first 24 hours after entry. One patient had substernal chest pain when endoscopy was attempted 3 hours after admission. The procedure was aborted, the patient received blood transfusions, and endoscopy repeated 12 hours later revealed a gastric ulcer. A second patient was uncooperative at the initial attempt 2 hours after entry, but endoscopy performed 6 hours later disclosed a marginal ulcer. Comments This study was designed to evaluate the effect of endoscopy on the management of upper gastrointestinal bleeding in actual clinical situations. The design chosen does not permit evaluation of the outcome (such as death) independently of the effects of therapy; that is, the results may be influenced by the biases and the knowledge or lack of it of the physicians. A different study design would be required to evaluate outcome, such as one in which all patients with a given diagnosis were treated according to a single protocol. Even that protocol is not ideal because the treatment programs chosen must be arbitrary, which in turn may influence the final outcome. In addition, assigning patients to treatment groups is a problem since they could be assigned based on the results of endoscopy, the clinical impression or a combination of the two. If all patients undergo endoscopy and are treated on the basis of the endoscopic opinion, the study becomes an evaluation of the treatment method and not endoscopy. If only some of the patients undergo endoscopy or if the results of endoscopy are not immediately revealed, as in this study, the results of treatment based on the endoscopic diagnosis can be compared with treatment based on the clinical impression. Treatment could either be predetermined, such as the “ideal” therapy of the 1970s or, as in the present study, the result of actual clinical decisions. Since only a small percentage of patients die from initial bleeding or rebleeding, the current study design would require many years and very large numbers of patients in 288
each group to identify differences in mortality, if they exist. All patients in the present study underwent endoscopy, so the possible hazards of the procedure cannot be investigated. To evaluate this question properly, patients must be randomized into “endoscopy” and “no endoscopy” groups. The latter design is not acceptable to physicians who believe that endoscopy is a mainstay of the management of patients with acute upper gastrointestinal hemorrhage. If endoscopy is important, as most nonacademic practicing physicians believe, this protocol would deny a critically important procedure to half of the patients. The results of the present study should help pave the way for more general acceptance of the endoscopy-no endoscopy design. In the present study, the physicians were asked, “What do you think the diagnosis is and what do you plan to do?” After the endoscopic procedure, half were asked, “Now that you know the results, what changes, if any, do you plan?” With the other half, these questions were asked 4 days later. All patients were followed to identify whether the changes in plan were actually performed. The endoscopy-no endoscopy protocol would not allow management per se to be investigated, unless endoscopy for diagnostic purposes was performed in all “no endoscopy” patients at a subsequent, standard time. The endoscopy-no endoscopy protocol also suffers from the same shortcomings as the present design; that is, it cannot evaluate outcome directly if management is the major variable. We found no difference in outcome whether the endoscopic results were revealed immediately or later. Theoretical objections related to a possible inability to measure outcome were less important clinically because most patients stop bleeding spontaneously. Would the results of the present study have been different if the population size had been larger? That is, although there was no noticeable difference between groups (clinical significance), would statistical significance have been obtained with more patients? To evaluate this question, one must look not only at the numbers but also at the data. The end pointsduration of hospitalization, time to start antacids or meals-are minor parameters, and even if larger numbers led to statistical significance, such significance would hardly justify endoscopy in all patients. In the present study design, the frequency of rebleeding is not an end point but rather a measurement of comparability of groups. Rebleeding would be an important variable in the endoscopy-no endoscopy protocol. Death is an important variable in any study. All deaths in the current study are recorded in Table V whether or not the deaths were The American Journal of Surgery
Endoscopy in the Management of Bleeding
related directly to the bleeding episode. If emergency endoscopy were to have a beneficial effect, it should become apparent early in the course of a bleeding episode. There were too few deaths in the 1st week of hospitalization for valid comparison. Two patients died from abrupt, exsanguinating rebleeding and died either on the way to or on the operating table. Endoscopy could not influence such cases, except theoretically, to have been the cause of rebleeding. Three additional patients with esophageal varices died. In only one of them was bleeding the cause of death, a Child’s group C patient in the No tell group who was clinically thought to have variceal bleeding. He died of abrupt exsanguination on the day after entry. To evaluate the end point of death, a much larger study population as well as a different study design would be required. The present study suggests that the low mortality associated with upper gastrointestinal hemorrhage is related not to the benefits of emergency endoscopy but to other factors such as the vigorous resuscitative measures employed. Was a difference in management obscured by the relatively small number of patients studied? Table VI presents all of the changes in management documented in this study, no matter how trivial. Interpretation of these data might vary, depending on the biases of the reader. For example, patient 18 was actively bleeding and was on the way to the operating room when the escape clause was activated. The operation was cancelled and no additional therapeutic plans were formulated. Fortunately, the patient stopped bleeding. However, it cannot be concluded that the decision was in the patient’s best interest. If a “meaningful” change in management demands a truly different direction in therapy, few meaningful changes occurred. Patients 3 and 5 (Table VI) had positive changes in management. In both cases the diagnosis of bleeding varices was not considered clinically and intravenous vasopressin therapy was begun when rebleeding occurred. Patient 3 died 35 days after entry. Although vasopressin is an acceptable therapy for bleeding esophageal varices, it is not proven effective and significant cardiovascular complications occur in at least 10 percent of patients [8-l 1 and unpublished observations]. In the present study nine patients with esophageal varices received vasopressin and two had myocardial infarctions, as did an additional patient treated with intraarterial vasopressin for bleeding Mallory-Weiss tear. No myocardial infarctions were noted in patients not receiving vasopressin. Considering the complication rate, at least two other patients, 1 and 16, received vasopressin in situations not justified by the risk: benefit ratio since neither patient was actively Volume 140, Augusl 1980
bleeding. The possible beneficial effects of endoscopy are apparently counterbalanced by the potentially harmful decisions that are generated. Taken in total, our results are unexpected in view of the widely touted and dogmatically stated premise that endoscopy is imperative for the proper management of patients with upper gastrointestinal bleeding. In retrospect it is obvious that endoscopy could not lead to immediate benefits for the majority of patients, such as those who stop bleeding and do not rebleed. What then is the role of endoscopy? For diagnosis, endoscopy is more accurate than roentgenography. Theoretically, the information obtained should be useful in planning the subsequent management of the underlying problem. This assumption is based on the unproven premise that long-term therapy and prognosis differ according to the source of bleeding. Endoscopy can also direct the form of therapy chosen to combat rebleeding or continued hemorrhage from a specific site. For example, the results of endoscopy can direct the surgeon to the bleeding site, thereby simplifying his task (personal communication: Paul H. Jordan, Jr.). Mallory-Weiss tears are frequently associated with other intragastric or duodenal disease [12], and knowledge of the presence of the tear directs the surgeon to that area in addition to the more obvious lesion. Endoscopy may also direct nonsurgical therapy such as angiotherapy for a Mallory-Weiss tear or Blakemore tube insertion for variceal bleeding. I believe that the current study demonstrates that emergency endoscopy is not necessary in most patients with upper gastrointestinal hemorrhage. In most instances endoscopy can safely be delayed for several days, at which time it could be done to diagnose the underlying disease so that long-term management could be planned. Thus the early complications of endoscopy such as chest pain (as in one of our patients) or the initiation of rebleeding can be avoided. In addition, a second endoscopic procedure for the biopsy of a gastric ulcer, because of poor patient cooperation or poor preparation, is unnecessary. The potential benefits of endoscopy are probably reserved for patients who either fail to stop bleeding or who have rebleeding; however, a subsequent study will be required to prove this hypothesis. Summary
In an 11 month period, 95 patients with acute upper gastrointestinal hemorrhage underwent early fiberoptic endoscopy. Patients were randomized into two groups before endoscopy depending on whether the results of the procedure were revealed immediately or after 4 days. No attempt was made to influ289
Graham
ence the treatment or diagnostic plan. The groups were comparable with respect to historical features surrounding the bleeding episode and the anatomic site of hemorrhage. There were no significant differences in any aspect of patient management or outcome between groups. Important changes in diagnostic or treatment plan were made after learning the results of endoscopy in only 12 percent of the patients, half of whom were bleeding briskly at the time of endoscopy. It is concluded that the natural history of acute upper gastrointestinal hemorrhage (for example, the spontaneous cessation of bleeding) precludes endoscopy from having a significant effect on patient management. References 1. Graham DY, Davis RE. Acute upper gastrointestinal hemorrhage. New observations on an old problem. Am J Dig Dis 197&23:76-U. 2. Keller RT. Logan GM Jr. Comparison of emergent endoscopy and upper gastrointestinal series radiography in acute upper gastrointestinal hemorrhage. Gut 1976; 17: 1.80-4. 3. Allan R, Dykes P. A comparison of routine and selective endoscopy in the management of acute gastrointestinal hem-
290
orrhage. Gastrointes Endos 1974;20: 154-5. 4. Morris DW, Levine GM, Soloway RD, Miller WT, Marin GA. Prospective, randomized study of diagnosis and outcome in acute upper gastrointestinal bleeding: endoscopy versus conventional radiography. Am J Dig Dis 1975;20:1103-9. 5. Sandlow LJ, Becker GH, Spellberg MA, et al. A prospective randomized study of the management of upper gastrointestinal hemorrhage. Am J Gastroenterol 1974;61:282-9. 6. Dronfield MW, Mclllmurray MB, Ferguson R, Atkinson M, Langman MJS. A prospective, randomised study of endoscopy and radiology in acute upper gastrointestinal tract bleeding. Lancet 1977;1:1167-9. 7. Child CG Ill. The liver and portal hypertension. Vol 1. Philadelphia: WB Saunders, 1964: 1. 8. Conn HO, Ramsby GR, Storer EH. Selective intraarterial vasopressin in the treatment of upper gastrointestinal hemorrhage. Gastroenterology 1972;63:634-45. 9. Conn HO, Ramsby GFt, Storer EH, et al. Intraarterial vasopressin in the treatment of upper gastrointestinal hemorrhage: a prospective, controlled clinical trial. Gastroenterology 1975;68:211-21. 10. Johnson WC, Widrich WC, Ansell JE, Robbins AH, Nabseth DC. Control of bleeding varices by vasopressin: a prospective randomized study. Ann Surg 1977;186:369-76. 11. Johnson WC, Widrich WC. Efficacy of selective splanchnic arteriography and vasopressin perfusion in diagnosis and treatment of gastrointestinal hemorrhage. Am J Surg 1976;131:481-9. 12. Graham DY, Schwartz JT. The spectrum of Mallory-Weiss tear. Medicine 1978;57:307-18.
The American Journal 01 Surgery
David Y. Graham, MD, Houston, Texas
Early endoscopy is of proven value in demonstrating the site of bleeding in patients with acute upper gastrointestinal hemorrhage [I]. Endoscopy is also established as a more accurate diagnostic procedure than roentgenography; moreover, it has been suggested that x-rays often provide misleading information [2]. Although endoscopy has become the accepted method of diagnosis in acute upper gastrointestinal hemorrhage, there are no controlled trials that directly answer the question of whether the information obtained by endoscopy significantly influences patient management. Several recent reports [2-61 have suggested that the outcome of a bleeding episode is the same whether or not a patient receives endoscopy or radiology as the initial diagnostic test and whether or not endoscopy is employed early or late in the course of the bleeding episode. The present study was designed to investigate the effect of early endoscopy on the decision-making process in patients with acute upper gastrointestinal hemorrage. The study revealed that, although early endoscopy yields the correct diagnosis in most patients, it has little effect on either the overall management or the eventual outcome of the acute bleeding episode. Methods Fiberoptic upper gastrointestinal endoscopy was performed early in the treatment of consecutive patients adFrom the Department of Medicine, Baylor College of Medicine, and Houston Veterans Administration Medical Center, Houston, Texas. Computational assistance was provided by the CLINFO Project, funded by the Division of Research Resources of the National Institutes of Health under contract NOl-RR-5-2118. Requests for reprints should be addressed to David Y. Graham, MD, Department of Medicine, Veterans Administration Medical Center, 2002 Holcombe Boulevard, Houston, Texas 77211.
284
mitted to Ben Taub General Hospital with acute upper gastrointestinal hemorrhage. Endoscopy was performed after hemodynamic stability and written consent were obtained. In each instance, the referring physician completed a standard questionnaire in which data pertaining to the present and previous bleeding episodes, if any, were listed and the clinical diagnosis and treatment plans were outlined. Each patient was then randomly assigned to one of two groups according to a schedule prepared from a table of random numbers. In one group the results of endoscopy were revealed immediately (the “Tell” group), while in the second group the results were sealed in an envelope placed in the patient’s chart, to be revealed after 4 days (the “No tell” group). The Tell group physicians were allowed to observe the endoscopic procedure; the physicians for the other group were not. After endoscopy the Tell group physicians recorded their opinions as to whether the information obtained was of benefit and whether it prompted any changes in plan. The No tell group was requested to record changes in plan daily for 4 days, at which time the results of endoscopy were revealed. After those results were known changes in plan or therapy were also recorded. No attempt was made to influence the physicians’ management decisions, and the patients were managed as the physicians believed appropriate. The results of the procedure in the No tell group could be disclosed earlier than the scheduled time using the following “escape clauses”: (1) brisk bleeding noted at endoscopy, (2) death or discharge of the patient, (3) a decision to proceed to surgery, and (4) recurrence of major bleeding after a significant therapeutic decision (such as the use of a Blakemore tube). The records of the patients were carefully reviewed to identify unrecorded changes in plan or protocol violations such as early revelation of endoscopy results. Major hemorrhage was defined as a decrease in hematocrit to 30 percent or below, a transfusion of 1,000 ml of blood without a corresponding increase in hematocrit or a decrease in hematocrit of 10 percent or more while under
The American Journal of Surgery
Endoscopy in the Management of Bleeding
TABLE I
TABLE II
Comparison of Historical Features* of Patients
Feature History Ulcert Mallory-Weisst Documented bleeding Undocumented bleeding Transfusions Comorbid diseases Liver Heart Lungs Ethanol use
Tell Group No. Percent+
9No.
Percent
39 12 39 18 22
13 4 12 9 6
28 9 26 20 13
0.6 0.8 0.2 0.9 0.5
12 2 4
24 4 8
13 2 4
28 4 9
0.6 0.9 0.9
Small intake/day None Large intake/day Aspirin use
8 22 19
<3 tablets/day None L3 tablets/day
12 27 10
16 45 39
7 18 21
15 39 I 46
Diagnosis
p>
19 6 19 9 11
0.8
Comparison of Clinical Impression With Actual Bleeding Site Impression Percent * No.
Peptic ulcer Unclassifiedt Duodenal Gastric Marginal Varices Mallory-Weiss Gastritis Esophagitis Aortoduodenal fistula Malignant Unknown
14 35 7 3 13 6 14 1 0 1 1
Total
95
14.7 36.8 7.4 3.2 13.7 6.3 14.7 1.1 . ;:1 1.1 100
Bleeding Site No. Percent 0 25 20 1 19 22 2 0 1 2 3 95
l
263 21.1 1.1 20.0 23.2 2.1 ;:1 2.1 3.1 100
Percent of total cases. t Site not specified. l
24 55 21
8 28 10
17 61 22 I
0.8
Before entry. t Percent of total cases. t Suggested by history. l
observation. Minor hemorrhage was defined as changes less than those noted above. The study was approved by the Human Experimentation Committee at Baylor College of Medicine and Ben Taub General Hospital, Houston, Texas. All patients signed informed consent for endoscopy and for entry into the study. Statistical analysis: Chi-square analysis or Fisher’s exact test was used to test for significance of difference and distribution of patients among various categories. Differences in numerical data for the two groups were compared using the two-tailed Student’s t test. The 5 percent significance level was used throughout.
Results From December 1976 to November 1977, ninetynine patients presenting to the hospital because of acute upper gastrointestinal hemorrhage were entered into the study. Four patients were subsequently excluded after randomization when it was discovered that they did not have acute upper gastrointestinal hemorrhage. The diagnoses in the excluded patients included chronic anemia and bleeding from the gums, the lungs and the colon. There was no difference in the frequency of major hemorrhage (91.6 percent) and minor hemorrhage (8.4 percent; three in the Tell group and five in the No tell group) (p >0.5). Demographic and historical data: There were no significant differences in the groups with regard to age, sex or racial distribution. The patients’ ages ranged from 18 to 77 years, with a mean of 45 (42 f
Volume 140, August lgg0
13, Tell group; 47 f 16, No tell group). There were 19 men and 30 women in the Tell group and 17 men and 29 women in the No tell group, with a racial distribution of 61.6 percent white and 48.4 percent black. There were 49 patients in the Tell group and 46 in the No tell group. There was no difference between groups with respect to the number of patients reporting either a history of abdominal pain suggestive of peptic ulcer disease or a history suggestive of Mallory-Weiss tear (vomiting, retching, coughing, seizure activity) preceding the bleeding episode (Table I). Similarly, there were no significant differences in the number of patients in each group with previous bleeding episodes, transfusions, ethanol or aspirin use, or in the frequency of significant comorbid conditions (Table I).
Comparison of clinical diagnosis with actual bleeding site: A comparison of the frequency of each clinical diagnosis with the frequency of that diagnosis as the actual bleeding site is shown in Table II. The initial diagnostic impression was correct in only 34 instances (36 percent). When duodenal, gastric, marginal and ulcer site not specified were grouped as peptic ulcer, the correct bleeding site was identified in 56 patients (59 percent). The reliability of specific clinical diagnoses was as follows: peptic ulcers were diagnosed 59 times and were correct in 41 cases (69 percent), varices were predicted 13 times and were correct in 10 cases (77 percent), and MalloryWeiss tears were diagnosed only 6 times and were correct in 3 cases (50 percent). In contrast, acute mucosal erosive lesions, esophagitis or gastritis were diagnosed on 15 occasions, and in no instance was that diagnosis correct.
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TABLE III
Comparison of Bleeding Sites in the Two Groups
Diagnosis
12 11 1 10 10 1 1 0 3
Total
49
l
No.
Percent
24.5 22.4 2.0 20.4 20.4 2.0 2.0
13 9 0 9 12 1 1
28.3 19.6 ;9:6 26.1 2.2 2.4
.6:1
01
2.2
100
46
Group *
Outcome
l
Tell
Duration of hospitalization (days) Time to Achieve diagnosis (hr) Start antacids (days) Start oral feeding (days) Start regular diet (days) Operations No. of cases Days from entry Emergency Elective Recurrence of bleeding No. of cases Days from entry Deaths No. Days from entry
100
Percent of total cases.
There was no statistical difference in the distribution of bleeding sites in the two groups (p >0.8) (Table III). Although there were approximately equal numbers of patients with bleeding esophageal varices in each group, the No tell group was slightly skewed (p <0.05) toward more severely ill patients as indicated by the hepatic functional reserve (Child’s criteria) [ 71. The Tell group had the following number of patients in each of the Child’s groups: A, two; B, five; and C, three. In the No tell group the distributions were A, one; B, one; and C, seven. Value of barium upper gastrointestinal x-rays: Upper gastrointestinal series were obtained in only 51 patients (53.7 percent), and there was no difference in the groups in the frequency of performance of barium x-ray examinations. Even when performed, x-rays had a poor diagnostic yield in that 59 percent were interpreted as normal and 15 percent as demonstrating nonspecific abnormalities such as irritable duodenum. Fourteen patients with duodenal ulcer
TABLE V
Effect of Knowledge of Endoscopy Results on Outcome
No Tell Group
Tell Group Percent* No.
Peptic ulcer Duodenal Gastric Marginal Varices Mallory-Weiss tear Gastritis Malignancy Aortoduodenal fistula Unknown
TABLE IV
No Tell
11.3 f
10
12.2 f
6.0 f 5 0.2 f 0.7 l.Of 1 2.3 f 2 11 5.0 f 5 6 5 5 2.2 f
1
4 22 f 22
p>
15
8.9 f 13+ 0.4 f 1 l.Of 1 2.1 f2 7 16.8 f 21 ;
0.30
0.14 0.30 0.30 0.30 0.63 0.18
}
0.63
10 7.8 f
15
0.11 0.26
6 13.7 f
16
0.55 0.61
Mean f standard deviation + Coded and not revealed. l
had an upper gastrointestinal series, and the correct diagnosis was obtained in 8. The lesions were identified by x-rays in 7 of 13 patients with gastric ulcer. Effect of knowledge of endoscopic results on outcome: There were no significant differences in the groups with respect to duration of hospitalization, time (hours) to achieve correct diagnosis or length of time (days) before instituting antacid therapy, oral feedings or regular diet (Table IV). In addition, there were no differences in the number of patients who had operation, recurrence of bleeding or death (Table V) or in the number of transfusions administered (Tell 4.2 f 0.6, No tell 3.4 f 0.5: p >0.3). Effect of endoscopy on diagnostic plan or therapy: The diagnostic plan or therapy was not
Summary of Patient Deaths
Bleeding Site Duodenal ulcer Varices Varicest Aortoduodenal fistula Varicesf Gastric ulcer Varices Mallory-Weiss tear+ Varices Duodenal ulcer+
Day of Death l
Surgery
0
.
1 2 3 5 11 32 32 35 49
. Emergency Emergency
. Elective Elective Emergency
Rebleeding
Cause of Death
Yes Yes No Yes Yes No Yes No Yes No
Bleeding Bleeding Respiratory failure+ Bleeding Sepsis Respiratory failure+ Hepatic Failure Sepsis Hepatic Failure Sepsis
Day(s) after entry. t Patient in the Tell group. f Adult respiratory distress syndrome. l
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The American Journal of Surgery
Endoscopy in the Management
changed in 74 (78 percent) of patients after the endoscopic diagnosis was revealed. There was a change in plan in 11 patients in the Tell group and 10 in the No tell group (Table V). The change of plan was considered important in only 11 (12 percent) of the patients, 6 of whom were bleeding briskly at the time of endoscopy, 4 from esophageal varices and 2 from peptic ulcer disease. Protocol violation manifested by inappropriate or early examination of the diagnosis was evident in only nine patients; the reasons given for violation ranged from a staff physician or surgeon wanting to know to disagreement in principle with the study. The only instance in which a protocol violation resulted in a significant change in either treatment or diagnostic plan was one that was not in the best interest of the patient (patient 16, Table VI). In that patient a nonbleeding gastric ulcer was treated with intravenous vasopressin and cimetidine. The bleeding sites in patients in whom protocol violations occurred were peptic ulcer disease in four, MalloryWeiss tear in two and esophageal varices in two. Most patients stopped bleeding either before or soon after coming to the hospital and brisk bleeding was noted at endoscopy in only 14 patients, 6 in the No tell group (ulcers, 3; varices, 3) and 8 in the Tell group (ulcers, 5; varices, 2; Mallory-Weiss tear, 1). Three of the briskly bleeding patients had emergency
TABLE VI
of Bleeding
surgery, and peptic ulcer was the site of bleeding in all three. Of the remaining 11 patients admitted with active bleeding, 4 (3 with varices and 1 with duodenal ulcer) had an episode of rebleeding. Recurrence of bleeding was uncommon. Only 15 (13 percent) of the patients not bleeding briskly on admission had a major episode of rebleeding with 8 (53 percent) having rebleeding within 48 hours. The bleeding sites in this group included esophageal varix, eight patients; duodenal ulcer, gastric ulcer and MalloryWeiss tear, two each, and aortoduodenal fistula, one. There was no statistical difference in the frequency with which the escape clause was used in the No tell group (six) and the frequency with which it would have been required in the Tell group (eight). The results of endoscopy were considered helpful by the involved physicians in only about one half of the cases: 51.1 percent in the Tell group and 53.3 percent in the No tell group (p >0.7). Deaths: The bleeding sites in the 10 patients who died included esophageal varices in 5; duodenal ulcer in 2; and Mallory-Weiss tear, gastric ulcer and aortoduodenal fistula in 1 each. Only three deaths were directly attributable to bleeding. The other deaths were related to the underlying disease or were complications of operation (Table V). Complications of endoscopy: There were no serious complications attributable to the endoscopic
Summary of Patients in Whom a Change In Plan Occurred After the Results of Endoscopy Were Revealed
Case
Bleeding
No.
Site
Initial impression
1 2’ 3 4’
Varices Varices Varices Varices
Gastritis Varices Gastric ulcer Varices
5’ 6 7’ 8’ 9 10 11’
Varices Varices Varices Varices Varices Varices Varices
Gastritis Gastritis Malignancy Peptic ulcer Varices Varices Varices
12’ 13’ 14’ 15
Peptic Peptic Peptic Peptic
Peptic ulcer Peptic ulcer Peptic ulcer Mallory-Weiss
16 17’ 18
Peptic ulcer Mallory-Weiss Mallory-Weiss
Gastritis Gastritis Peptic ulcer
19 20 21
Mallory-Weiss Malignancy Peptic ulcer
Varices Peptic ulcer Peptic ulcer
ulcer ulcer ulcer ulcer
Active Bleeding
+ + +
+
Result of Change in Plan
Importance of Change
Vasopressin given Vasopressin given Vasopressin given Used Sengstaken-Blakemore tube instead of angiogram with vasopressin Vasopressin given No antacid given Liver biopsy done Discontinued barium enema Discontinued upper gastrointestinal series Discontinued upper gastrointestinal series Postshunt patient: later obtained elective angiogram for shunt patency Elective surgery planned Outlet obstruction found and treatment begun Discontinued upper gastrointestinal series Active bleeding; decided on surgery; changed to intraarterial vasopressin when diagnosis known Intravenous vasopressin and cimetidine begun Discontinued Maalox Rebleeding; surgeon decided not to operate when diagnosis known Told surgeon consult not needed Plan to operate, elective Immediate surgery
+ + + +
+ + + + +
* Patient in the Tell group.
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procedure. Whether the procedure itself was deleterious (restarting bleeding, for example) cannot be ascertained from this study because almost all of the patients underwent endoscopy. In two uncooperative patients, endoscopy could not be performed. One of them had a classic history for Mallory-Weiss tear and normal findings on barium examination. The other patient had been asymptomatic before bleeding and had normal findings on x-ray examination. Another patient had a history consistent with Mallory-Weiss tear, but no tear was seen at endoscopy; the upper gastrointestinal x-rays were normal and endoscopy was not repeated. Two patients underwent endoscopy twice in the first 24 hours after entry. One patient had substernal chest pain when endoscopy was attempted 3 hours after admission. The procedure was aborted, the patient received blood transfusions, and endoscopy repeated 12 hours later revealed a gastric ulcer. A second patient was uncooperative at the initial attempt 2 hours after entry, but endoscopy performed 6 hours later disclosed a marginal ulcer. Comments This study was designed to evaluate the effect of endoscopy on the management of upper gastrointestinal bleeding in actual clinical situations. The design chosen does not permit evaluation of the outcome (such as death) independently of the effects of therapy; that is, the results may be influenced by the biases and the knowledge or lack of it of the physicians. A different study design would be required to evaluate outcome, such as one in which all patients with a given diagnosis were treated according to a single protocol. Even that protocol is not ideal because the treatment programs chosen must be arbitrary, which in turn may influence the final outcome. In addition, assigning patients to treatment groups is a problem since they could be assigned based on the results of endoscopy, the clinical impression or a combination of the two. If all patients undergo endoscopy and are treated on the basis of the endoscopic opinion, the study becomes an evaluation of the treatment method and not endoscopy. If only some of the patients undergo endoscopy or if the results of endoscopy are not immediately revealed, as in this study, the results of treatment based on the endoscopic diagnosis can be compared with treatment based on the clinical impression. Treatment could either be predetermined, such as the “ideal” therapy of the 1970s or, as in the present study, the result of actual clinical decisions. Since only a small percentage of patients die from initial bleeding or rebleeding, the current study design would require many years and very large numbers of patients in 288
each group to identify differences in mortality, if they exist. All patients in the present study underwent endoscopy, so the possible hazards of the procedure cannot be investigated. To evaluate this question properly, patients must be randomized into “endoscopy” and “no endoscopy” groups. The latter design is not acceptable to physicians who believe that endoscopy is a mainstay of the management of patients with acute upper gastrointestinal hemorrhage. If endoscopy is important, as most nonacademic practicing physicians believe, this protocol would deny a critically important procedure to half of the patients. The results of the present study should help pave the way for more general acceptance of the endoscopy-no endoscopy design. In the present study, the physicians were asked, “What do you think the diagnosis is and what do you plan to do?” After the endoscopic procedure, half were asked, “Now that you know the results, what changes, if any, do you plan?” With the other half, these questions were asked 4 days later. All patients were followed to identify whether the changes in plan were actually performed. The endoscopy-no endoscopy protocol would not allow management per se to be investigated, unless endoscopy for diagnostic purposes was performed in all “no endoscopy” patients at a subsequent, standard time. The endoscopy-no endoscopy protocol also suffers from the same shortcomings as the present design; that is, it cannot evaluate outcome directly if management is the major variable. We found no difference in outcome whether the endoscopic results were revealed immediately or later. Theoretical objections related to a possible inability to measure outcome were less important clinically because most patients stop bleeding spontaneously. Would the results of the present study have been different if the population size had been larger? That is, although there was no noticeable difference between groups (clinical significance), would statistical significance have been obtained with more patients? To evaluate this question, one must look not only at the numbers but also at the data. The end pointsduration of hospitalization, time to start antacids or meals-are minor parameters, and even if larger numbers led to statistical significance, such significance would hardly justify endoscopy in all patients. In the present study design, the frequency of rebleeding is not an end point but rather a measurement of comparability of groups. Rebleeding would be an important variable in the endoscopy-no endoscopy protocol. Death is an important variable in any study. All deaths in the current study are recorded in Table V whether or not the deaths were The American Journal of Surgery
Endoscopy in the Management of Bleeding
related directly to the bleeding episode. If emergency endoscopy were to have a beneficial effect, it should become apparent early in the course of a bleeding episode. There were too few deaths in the 1st week of hospitalization for valid comparison. Two patients died from abrupt, exsanguinating rebleeding and died either on the way to or on the operating table. Endoscopy could not influence such cases, except theoretically, to have been the cause of rebleeding. Three additional patients with esophageal varices died. In only one of them was bleeding the cause of death, a Child’s group C patient in the No tell group who was clinically thought to have variceal bleeding. He died of abrupt exsanguination on the day after entry. To evaluate the end point of death, a much larger study population as well as a different study design would be required. The present study suggests that the low mortality associated with upper gastrointestinal hemorrhage is related not to the benefits of emergency endoscopy but to other factors such as the vigorous resuscitative measures employed. Was a difference in management obscured by the relatively small number of patients studied? Table VI presents all of the changes in management documented in this study, no matter how trivial. Interpretation of these data might vary, depending on the biases of the reader. For example, patient 18 was actively bleeding and was on the way to the operating room when the escape clause was activated. The operation was cancelled and no additional therapeutic plans were formulated. Fortunately, the patient stopped bleeding. However, it cannot be concluded that the decision was in the patient’s best interest. If a “meaningful” change in management demands a truly different direction in therapy, few meaningful changes occurred. Patients 3 and 5 (Table VI) had positive changes in management. In both cases the diagnosis of bleeding varices was not considered clinically and intravenous vasopressin therapy was begun when rebleeding occurred. Patient 3 died 35 days after entry. Although vasopressin is an acceptable therapy for bleeding esophageal varices, it is not proven effective and significant cardiovascular complications occur in at least 10 percent of patients [8-l 1 and unpublished observations]. In the present study nine patients with esophageal varices received vasopressin and two had myocardial infarctions, as did an additional patient treated with intraarterial vasopressin for bleeding Mallory-Weiss tear. No myocardial infarctions were noted in patients not receiving vasopressin. Considering the complication rate, at least two other patients, 1 and 16, received vasopressin in situations not justified by the risk: benefit ratio since neither patient was actively Volume 140, Augusl 1980
bleeding. The possible beneficial effects of endoscopy are apparently counterbalanced by the potentially harmful decisions that are generated. Taken in total, our results are unexpected in view of the widely touted and dogmatically stated premise that endoscopy is imperative for the proper management of patients with upper gastrointestinal bleeding. In retrospect it is obvious that endoscopy could not lead to immediate benefits for the majority of patients, such as those who stop bleeding and do not rebleed. What then is the role of endoscopy? For diagnosis, endoscopy is more accurate than roentgenography. Theoretically, the information obtained should be useful in planning the subsequent management of the underlying problem. This assumption is based on the unproven premise that long-term therapy and prognosis differ according to the source of bleeding. Endoscopy can also direct the form of therapy chosen to combat rebleeding or continued hemorrhage from a specific site. For example, the results of endoscopy can direct the surgeon to the bleeding site, thereby simplifying his task (personal communication: Paul H. Jordan, Jr.). Mallory-Weiss tears are frequently associated with other intragastric or duodenal disease [12], and knowledge of the presence of the tear directs the surgeon to that area in addition to the more obvious lesion. Endoscopy may also direct nonsurgical therapy such as angiotherapy for a Mallory-Weiss tear or Blakemore tube insertion for variceal bleeding. I believe that the current study demonstrates that emergency endoscopy is not necessary in most patients with upper gastrointestinal hemorrhage. In most instances endoscopy can safely be delayed for several days, at which time it could be done to diagnose the underlying disease so that long-term management could be planned. Thus the early complications of endoscopy such as chest pain (as in one of our patients) or the initiation of rebleeding can be avoided. In addition, a second endoscopic procedure for the biopsy of a gastric ulcer, because of poor patient cooperation or poor preparation, is unnecessary. The potential benefits of endoscopy are probably reserved for patients who either fail to stop bleeding or who have rebleeding; however, a subsequent study will be required to prove this hypothesis. Summary
In an 11 month period, 95 patients with acute upper gastrointestinal hemorrhage underwent early fiberoptic endoscopy. Patients were randomized into two groups before endoscopy depending on whether the results of the procedure were revealed immediately or after 4 days. No attempt was made to influ289
Graham
ence the treatment or diagnostic plan. The groups were comparable with respect to historical features surrounding the bleeding episode and the anatomic site of hemorrhage. There were no significant differences in any aspect of patient management or outcome between groups. Important changes in diagnostic or treatment plan were made after learning the results of endoscopy in only 12 percent of the patients, half of whom were bleeding briskly at the time of endoscopy. It is concluded that the natural history of acute upper gastrointestinal hemorrhage (for example, the spontaneous cessation of bleeding) precludes endoscopy from having a significant effect on patient management. References 1. Graham DY, Davis RE. Acute upper gastrointestinal hemorrhage. New observations on an old problem. Am J Dig Dis 197&23:76-U. 2. Keller RT. Logan GM Jr. Comparison of emergent endoscopy and upper gastrointestinal series radiography in acute upper gastrointestinal hemorrhage. Gut 1976; 17: 1.80-4. 3. Allan R, Dykes P. A comparison of routine and selective endoscopy in the management of acute gastrointestinal hem-
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orrhage. Gastrointes Endos 1974;20: 154-5. 4. Morris DW, Levine GM, Soloway RD, Miller WT, Marin GA. Prospective, randomized study of diagnosis and outcome in acute upper gastrointestinal bleeding: endoscopy versus conventional radiography. Am J Dig Dis 1975;20:1103-9. 5. Sandlow LJ, Becker GH, Spellberg MA, et al. A prospective randomized study of the management of upper gastrointestinal hemorrhage. Am J Gastroenterol 1974;61:282-9. 6. Dronfield MW, Mclllmurray MB, Ferguson R, Atkinson M, Langman MJS. A prospective, randomised study of endoscopy and radiology in acute upper gastrointestinal tract bleeding. Lancet 1977;1:1167-9. 7. Child CG Ill. The liver and portal hypertension. Vol 1. Philadelphia: WB Saunders, 1964: 1. 8. Conn HO, Ramsby GR, Storer EH. Selective intraarterial vasopressin in the treatment of upper gastrointestinal hemorrhage. Gastroenterology 1972;63:634-45. 9. Conn HO, Ramsby GFt, Storer EH, et al. Intraarterial vasopressin in the treatment of upper gastrointestinal hemorrhage: a prospective, controlled clinical trial. Gastroenterology 1975;68:211-21. 10. Johnson WC, Widrich WC, Ansell JE, Robbins AH, Nabseth DC. Control of bleeding varices by vasopressin: a prospective randomized study. Ann Surg 1977;186:369-76. 11. Johnson WC, Widrich WC. Efficacy of selective splanchnic arteriography and vasopressin perfusion in diagnosis and treatment of gastrointestinal hemorrhage. Am J Surg 1976;131:481-9. 12. Graham DY, Schwartz JT. The spectrum of Mallory-Weiss tear. Medicine 1978;57:307-18.
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