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A prospective randomized study comparing forceful dilatation and esophagomyotomy in patients with achalasia of the esophagus
GASTROENTEROLOGY
1981;80:789-95
A Prospective Randomized Study Comparing Forceful Dilatation and Esophagomyotomy in Patients with Achalasia of the Esophagus ATTILA CSENDES, NICHOLAS VELASCO, ITALO BRAGHETTO, and ANA HENRIQUEZ Gastrointestinal Unit, Department of Surgery, University of Chile, Santiago, Chile
A prospective and randomized study was performed comparing pneumatic forceful dilatation and surgical esophagomyotomy as primary treatment of patients with achalasia of the esophagus. Eighteen dilated and 20 operated patients were studied before and after treatment with 1 patient lost. Clinical, radiologic, and manometric evaluations were performed before and after treatment and acid reflux test in the late follow-up period. Immediately after treatment, a significant improvement was seen clinically, by radiologic studies and after manometric evaluation. In the late follow-up period, operated patients showed a permanent improvement in all of them, but dilated patients remained a symptomatic in about 50% of the cases. The rest had to be redilated or reoperated on due to a failure of primary dilatation leading to final good or excellent results in 60% and failure in 40% of patients. Acid rej7ux test showed a positive test in 31% of the operated patients and in 7% of the dilated patients. This controlled study suggests that surgical treatment of achalasia, used as primary treatment, is accompanied by significantly better long-term results compared with pneumatic dilatation according to the technique utilized by us. The best actual treatment for achalasia of the esophagus is based on the destruction of muscle fibers at the gastroesophageal sphincter in order to obtain an adequate emptying of the esophagus. This goal can
Received May 27, 1980.Accepted November 21, 1980. Address requests for reprints to: Attila Csendes, M.D., Centro de Gastroenterologia, Hospital J. J. Acquirre, Santos Dumont 999, Santiago, Chile. We are grateful to Dr. Charles E. Pope II for his critical review of this manuscript. 0 1981 by the American Gastroenterological OOlS-5085/81/040789-07$02.50
Association
Hospital
Clinico Jose Joaquin Aguirre,
be achieved either by a forceful pneumatic dilatation (l-9) or by surgical esophagomyotomy (10-20). The long-term results obtained after these procedures have been published by several authors; there is no prospective randomized trial of the two methods. The purpose of the present study was to perform such a prospective and randomized clinical trial comparing the medical or surgical treatment in patients with achalasia treated by the same criteria and the same medical group in order to determine if there is a significative difference in the long-term results.
Material and Methods Thirty-eight consecutive patients were included in this prospective study, which began in January, 1973 and ended in July, 1979. All of them had either achalasia type I or II, i.e., mild or moderate esophageal dilatation seen in xray studies thus making them eligible for either treatment. Patients with severe “Sigmoid” dilatation of the esophagus were excluded from this study. Patients dilated or treated previously were not included. After completing clinical and laboratory studies, they were randomly assigned to two groups: A. Dilated group: Eighteen patients (12 females and 6 males) with a mean of 38 yr (range 15-73 yr). B. Operated group: 20 patients (11 females and 9 males) with a mean age of 42 yr (range 22-83 yr). All patients had serologic tests for Chagas disease. tests were positive in 5 cases (13%). In all patients the following studies were performed fore any treatment and in the final follow-up period:
The be-
1. Clinical analysis with careful attention to presence and duration of dysphagia, presence of heartburn, loss or
790
CSENDES ET AL.
gain of weight, regurgitation, and presence of pulmonary symptoms. Dysphagia was classified clinically as follows: (a) Mild dysphagia corresponded to patients in whom the bolus of meat or solids would stick occasionally, but not liquids. (b) Moderate dysphagia occurred when patients could take only minced foods. (c) Severe dysphagia meant that patients could tolerate liquids only. Radiologic studies in the upright position (not in recumbent position) with careful evaluation of two parameters in reviewed independently by two of the authors: (a) maximal internal diameter of the narrowed segment at the gastroesophageal junction during the flux of barium, and (b) maximal internal diameter of the middle third of the esophagus. Manometric studies with three polyethylene catheters (ID 1.4 mm) constantly perfused by a Harvard infusion pump at a rate of 2 ml/min. (21-23). The compliance of our system showed a presence rise time of 90 mmHg during l-s occlusion. Zero values represent end expiratory fundic pressure. All values are expressed in mmHg as mean -tSEM. Tracings were read and measured by the same author before and after treatment (A. Csendes) and were reviewed blindly by two other authors (N. Velasco and I. Brachetto). Acid reflux test was performed in the follow-up study by attaching a glass electrode (Pye Unicam) to the manometric assembly. This test was performed according to the method described previously (24). Pneumatic dilatation was done by the same author in all patients with a Mosher bug under fluoroscopic observation. Patients were premeditated with 0.5 mg of atropine and a slight pharyngeal anesthesia. Once the bag was placed in the correct position, it was inflated rapidly to 1215 lbs./in.‘, and when completely inflated, it remained so for 3-5 s, and this procedure was done two times. The maximal diameter of the Mosher bag, which was achieved at the gastroesophageal junction when completely inflated, was 5 cm. The duration for this procedure was 1 min. It was impossible for it to remain inflated more than 5 s, each time because all patients had intense pain and discomfort. When the balloon was removed, it always contained blood, which indicated some degree of mucosal
damage. All patients were hospitalized and were observed for 24 h, and then discharged. The full recovery period was 1 wk. Surgery was performed by the same author in all cases (A. Csendes). The surgical procedure was performed by a transabdominal route. After careful isolation of the abdominal esophagus and gastroesophageal junction, an anterior esophagomyotomy was performed according to Zaaijer’s technique (25) (Figures l-3). Five to 6 cm of the distal esophageal muscle fibers and not more than 5 mm of gastric muscle fibers were resectioned. If esophageal mucosa was accidentaly opened (in 4 cases), it was sutured with 3-O plain catgut. A fundic serosal patch was added in all patients for two reasons: as prevention of fistula development if mucosa has been opened and mainly because suturing the muscular edges to the serosal surface of the stomach offsets the possibility of future reaproximation of
GASTROENTEROLOGY
Vol. 80, No. 4
muscle fibers. The average hospital stay was 8 days (1 day before and 6-7 days after surgery). Students t-test for paired values was used for statistical analaysis of the data.
Results Clinical
Analysis
Operated group. Before treatment all patients had dysphagia and regurgitation with a mean duration of 4.4 yr. There was no operative mortality. Two patients had an important infection of laparotomy, and 1 of them had to be reoperated for left subphrenic abscesses. No postoperative fistula occurred in any patient. After surgery all patients became asymptomatic and gained weight. The total time lost from work and for complete convalescence from surgery was 4 wk. One patient died 6 mo after surgery. Nineteen cases were followed for a mean of 43 mo (range 1683 mo). Twelve were completely asymptomatic, and 7 had occasional mild dysphagia. All of them were happy with the surgical results. Two of them had mild heartburn (Table 1). Dilated group. Before treatment all patients had dysphagia and regurigitation of 2.7 yr. There were no complications after dilatation. Immediately after treatment patients became asymptomatic and gained weight. All were followed up with a mean duration of 42 mo (range 15-73 mo). Eight patients were asymptomatic (44%). Four patients had mode rate or severe dysphagia, but refused other treatment. Three patients were dilated again (2 of them one time and 1 in two occasions). After redilatation 2 of them still had mild dysphagia, and 1 was asymptomatic. Three patients had to be operated on due to severe, persistent dysphagia. None of the dilated patients had heartburn (Table 1).
Radiologic
Studies
Gastroesophageai junction. There was a significant increase in the diameter of the narrowed segment at the gastroesophageal junction after either treatment (Table 2) (p < 0.01). Operated patients had a larger diameter than the dilated patients. In this later group, patients with symptoms still had a narrow segment in the last follow-up period. Middle third of the esophagus. There was a significant decrease in the maximal internal diameter of the middle third of the thoracic esophagus after dilatation and operation (p < 0.01). Symptomatic patients had larger diameters than did asymptomatic patients (Table 2).
April
1981
Figure
DILATATION
1. Distance
of surgical
section
Figure
in esophagomyotomy
2. Section
of the muscle
and resection
layer
AND ESOPHAGOMYOTOMY
IN ACHALASIA
of the fat pad at the esophagogastric
of the esophagus
and cardia.
junction.
791
792
GASTROENTEROLOGY
CSENDES ET AL.
Vol. 80, No. 4
Figure 3. Suture of the fundic serosa to both muscular edges of the esophagus.
Manometric
Studies
Body of the esophagus. There were no significant differences in the amplitude of the contractile nonperistaltic waves of the esophageal body before and after treatment (Table 3). In all cases no peristaltic waves were recorded, and deglutitions induced 100% of simultaneous waves. None of the patients showed peristaltic waves after treatment. Resting intraesophageal pressure was above fundic pressure in all patients before treatment and became negative after treatment. Gastroesophageal sphincter pressure. OPERATED GROUP: Before surgery patients had a mean resting GESP of 30.3f 3.8 mmHg. In all of them a significant fall in sphincteric pressure was observed 1 mo after surgery with a mean value of 7.6 f 0.9 mmHg ( p < 0.001). In the late follow-up, sphincter pressure had a mean value of 8.4 f 1.3 mmHg. None of these cases had zero values for sphincter pressure, i.e., abscence of gastroesophageal sphincter pressure (Figure 4). DILATED GROUP: Before dilatation patients had a mean resting GESP of 30.0 f 3.1 mmHg. One month after dilatation there was a significant decrease in GESP with a mean value of 15.2 f 1.7 mmHg (p < 0.01). In the last follow-up period two groups were identified (Figure 5). Eight asympto-
matic patients showed no change in GESP with a mean resting value of 14.5 + 1.5 mmHg. Ten patients who were symptomatic or required further dilatation or operation showed no significant difference in resting GESP values before treatment, compared with the last follow-up period. Acid Reflux Test Operated group: This test was performed in of 19 patients. It was positive in 5 (31%) and negative in 11. Only 2 patients of the positive test group had mild heartburn. Dilated group. The acid reflux test was performed in 15 of 18 patients, and it was positive in only 1 patient (7%). None of them had heartburn. 16
Table 1.
Clinical Results in the Randomized Study
Operated = 20 (1 lost) 12 Asymptomatic 7 With mild dysphagia 2 With heartburn
Dilated = 18 8 4 3 3 0
Asymptomatic Moderate or severe dysphagia Redilated Operated Heartburn
April 1981
Table
2.
DILATATION AND ESOPHAGOMYOTOMY
Radiologic
Studies
Gastroesophageal junction (mm) Before Treatment Late follow-up period Middle third of the esophagus (mm) Before Treatment Late follow-up period
Dilatation
Operation
2.6 f 0.4
2.2 f 0.2
6.6 f 0.6
8.5 f 0.5
46.5
f
1.7
29.6 f 0.2
50.5 f 2.6 27.5
f
1.6
Discussion The results of this prospective and randomized study comparing pneumatic dilatation or esophagomyotomy as treatment of achalasia of the esophagus suggest that significantly better, longterm results can be obtained after surgical esophagomyotomy than after forceful dilatation. There is no doubt that the definitive treatment for achalasia is based on the section of the muscle fibers at the gastroesophageal junction either by pneumatic dilatation or esophagomyotomy. Other methods like anticholinergics, dilatation by mercuryfilled bougies, cardioplasty, or esophagogastrectomy are unsuccesful, with a high recurrence rate (14-26). Several authors in retrospective studies have favored pneumatic dilatation as the primary treatment for achalasia. Clinical and radiologic follow-up of patients treated by this method have reported excellent or good results in 70%-75% of the cases (l-9, 27), figures higher than our results. The advantage of this method is that it is a rapid procedure, with no more than 1 day hospitalization, as in our cases, and it avoids a surgical procedure. However several disadvantages can be mentioned: (a) The perforation rate of the esophagus reported by many authors is between 2% and 6% although the 1974 ASGE study reported perforation rate was 1%. (b) The way to obtain the rupture or section of the muscle fibers is from inside the lumen to outside, which means some degree of rupture of the mucosa and incomplete and “blind” section of the circular muscular layer. Therefore, there is no way to control the magnitude
Table
3.
Manometric Esophagus
Features
IN ACHALASIA
793
of this section. In our dilated group, we obtained with our method final results that were either good or excellent in 60% (11 patients) and failures in 40% (7 patients). It is possible that the appearance or persistence of dysphagia in these patients could be partly due to some mechanical factor, maybe produced by an intramural hematoma and subsequent fibrosis caused by the sudden rupture of the circular muscle of the distal esophagus by the dilator bag. This was clearly seen in the 3 patients who had to be operated on due to failure of dilatation. In them, the distal esophagus was firm and fibrous, and it was very difficult to separate the muscular layer from the mucosa clearly, by careful dissection. In all of them, in order to achieve a complete muscular section, the mucosal layer had to be opened. In the last year several publications have favored surgical treatment for achalasia (lo-20,28). Different authors, including us, have reported good or excellent results in over 80% of all operated patients (29). However, the disadvantages of this method are that patients are submitted to surgical risk (which is minimum), some degree of complications can occur, and several days of hospitalization are necessary, In addition, the incidence of gastroesophageal reflux is variable, from 5% to 50% (14,16,17,19,20,29). However, several advantages can be reported: (a) The section of the muscle fibers is done under direct vision; therefore, a very careful treatment can be performed. (b) If a malignant tumor is discovered, it is treated immediately. And (c) if there is another abdominal disease, it can be treated. In the assessment of these results, it can be argued that the application of these methods of treatment, dilatation and specially surgical procedure, requires a good deal of expertise, and the methods used are also different, and therefore conclusions could be EFFECT GESP cmmtfg
) 70 60 i
OF ESOPHAGOMYOTOMY 20 PATIENTS
-) prcop- poslop and 9 1
-
preop
proscnl
and present
of the Body of the
Dilatation Amplitude waves (mmHg) of Nonperistaltic contractions Before treatment 29.4 f 5.2 Late follow-up period 31.7 f 5.3 Intraesophageal resting pressure (mmHg) Before Treatment + 5.6 Late follow-up period -1.7
Operation
25.9 f 4.1 23.7
f 2.8
+ 6.4 -3.6
Figure
4.
Effect of esophagomyotomy sphincter pressure (GESP).
on
gastroesophageal
794
CSENDES
ET AL.
GASTROENTEROLOGY
EFFECT
OF
PNEUMATIC 18 PATIENIS
GESP rmmtfg,, 70
Vol. 80, No. 4
DILATATION
G,ESP rmmHg, 704 1
60 i
Figure
5. Effect of pneumatic esophageal sphincter
dilatation pressure
WELL
AFTER
I DILATATION
=8
60-
NOT WELL AFTER
I DlLAlATlON.=lO
on Gastro(GESP).
valid only for the individual operator. It is probable that to some degree physician’s expertise can influence the widely different results reported in the literature on the two different methods. Accordingly, this argument could invalidate any clinical trial. It is obvious that every physician or surgeon has some special details when performing a technique, which leads to minor differences from one author to another. However, the main principles are the same, and those are what we are comparing: pneumatic dilatation and esophagomyotomy. Gastroesophageal reflux can be avoided by careful surgical technique. The incision in the esophagus must be long enough (5-6 cm) to assure a complete section and adequate esophageal emptying. In the stomach it must be placed in the lesser curve of the stomach so that reflux is likely to be diminished. We prefer a single, longitudinal myotomy limited to the esophagus, and not more than 5-10 mm to the lesser curve of the stomach, because in this way a residual sphincter activity is left, as was observed in all our patients. More radical incisions, especially 2 cm or more of the stomach, as has been advocated by some authors, may lead to a high percentage of reflux (1920) due to complete section of the gastric sling fibers. With our surgical technique, we have observed a 30% incidence of esophageal reflux, mostly asymptomatic. We have not observed severe gastroesophageal reflux and stricture with this surgical technique. We find little reason to transsect more than 5 mm of the muscular coat of the stomach, because the gastric musculature plays little role in the obstructive mechanism seen in achalasia, but an intact band at the gastroesophageal junction may leave residual constriction and may permit herniation of the mucosa, leading to an epiphrenic type of diverticulum. The decrease in sphincter pressure is permanent after this surgical technique, as can be seen in our
patients. This residual sphincter activity may explain the low incidence of gastroesophageal reflux. Our study confirms a previous publication of a retrospective study by Arvanitakis (31) and by Yon and Christensen (26). The latter authors reported 85% good results after esophagomyotomy and 46% after dilatation, values very similar to ours. However, they ascribe the poor results of forceful dilatation to the fact that the dilatations were carried out by different physicians. Arvanitakis reported 65% good results after dilatation and 91% after esophagomyotomy. Both publications report gastroesophageal reflux in a similar percentage to ours. After treatment, adequate emptying is obtained from the esophagus, but esophageal aperistalsis is not changed in our patients. It is not clear why no return to peristalsis was observed in any of our patients, as was observed by Vantrappen et al. (8). In summary, in this prospective controlled trial, we have obtained significantly better long-term results in patients with achalasia of the esophagus when treated surgically than when submitted to forceful dilatation according to our technique.
References 1. Bennett JR, Bargaza E, Hendrix JR, Siegel CF. Treatment of achalasia by pneumatic dilatation of the cardia. Gut 1968;9:727-31. 2. Heitmann P, Wienbeck M. The immediate effect of successful pneumatic dilatation on esophageal function in achalasia. Stand J Gastroenterol 1972;7:197-294. DJ, Raskin HF, Kirsner JB, Palmer WL. Therapeutic 3. Kurlander value of the pneumatic dilatation in achalasia of the esophagus. Gastroenterology 1963;45:664-13. EM. Treatment of the achalasia of the cardia. Gastro4. Nanson enterology 1966;51:236-41. AM, Harrington SW, Moersch HJ, Andersen HA. The 5. Olsen
April 1961
6.
7.
6.
9. 10.
11.
12. 13. 14.
15.
16.
17.
DILATATION AND ESOPHAGOMYOTOMY
treatment of cardiospasm, analysis of twelve years experience. J Thorac Cardiovasc Surg 1951;22:164-67. Sanderson DR, Ellis HF, Olsen AL. Achalasia of the esophagus, results of therapy by dilatation 1950-1967. Chest 1970; 56:116-21. Van Giodsenhoven GE, Vantrappen G, Verbeke S, Vandenbroucke J. Treatment of achalasia of the cardia with pneumatic dilatations. Gastroenterology 1963;45:326-34. Vantrappen G, Giodsenhoven GE, Verbeke S, et al. Manometric studies in achalasia of the cardia before and after pneumatic dilatations. Gastroenterology 1963;45:317-25. Vantrappen G, Hellemans J, Deloof W, et al. Treatment of achalasia with pneumatic dilatations. Gut 1971;12:266-75. Ellis FH, Olsen AM, Holman CB, Code CE. Surgical treatment of cardiospasm (achalasia of the esophagus). JAMA 1956; X6:29-36. Jara FM, Toledo-Pereira LH, Lewis JW, Magilligan DJ. Long term results of esophagomyotomy for achalasia of the esophagus. Arch Surg 1979114935-6. Rees JR, Thorbynarson B, Barnes WH. Achalasia: results of operation in 64 patients. Ann Surg 1970;171:195-201. Payne WS, Ellis FH. Olsen AM. Achalasia of the esophagus. Arch Surg 1969;61:91-6. Sawyers JL, Foster JH. Surgical considerations in the management of the achalasia of the esophagus. Ann Surg 1967; 165:76CI-5. Hawthorne HR, Frobese AS, Nemir P. The surgical management of achalasia of the esophagus. Ann Surg 1956;144:65369. Menzies Gow J, Gummer JWP, Edwards DAW. Results of Heller’s operation for achalasia of the cardia. Br J Surg 1976;65:463-5. Ellis FH, Kiser JC, Schlegel JF, et al. Esophagomyotomy for achalasia of the esophagus. Ann Surg 1967;166:646-56.
IN ACHALASIA
795
16. Wingfield MV, Karwowski A. The treatment of achalasia by cardiomyotomy. Br J Surg 1972;59:261-4. 19. Effler DB, Loop F, Groves LK, Favaloro AG. Primary surgical treatment for esophageal achalasia. Surg Gynecol Obstet 1971;132:1057-63. 20. Rapant V, Kralik J. Heller’s radical myotomy in the treatment of achalasia of the esophagus. Sot lnt Chir 1966;8:656-62. 21. Heitmann P, Espinoza J. Csendes A. Phisiology of the distal esophagus in achalasia. Stand J Gastroenterol 1969;4:1-11. 22. Csendes A, Larrain A. Effect of posterior gastropexy on gastroesophageal sphincter pressure and symptomatic reflux in patients with hiatal hernia. Gastroenterology 1972;63:19-24. 23. Uribe P, Csendes A, Larrain A, Ayala M. Motility studies in fifty patients with achalasia of the esophagus. Am J Gastroenterol 1974;62:333-6. 24. Csendes A, Oster M, Moller J, et al. Gastroesophageal reflux in duodenal ulcer patients before and after vagotomy. Ann Surg 1976;168:694-6. 25. Zaaijer JH. Cardiospasm in the aged. Ann Surg 1923;77:615-7. 26. Yon J, Christensen J. An uncontrolled comparison of treatment for achalasia. Ann Surg 1975;162:672-6. 27. Csendes A, Strauszer T. Long term clinical, radiological and manometric follow up period of patients with achalasia treated with pneumatic dilatation. Digestion 1974;11:126-34. 26. Clagett OT. Achalasia: dilatation or myotomy? J Thorac Cardiovasc Surg 1967;53:757-6. 29. Csendes A, Larrain A, Strauszer T, Ayala M. Long term clinical, radiological and manometric follow up period of patients with achalasia of the esophagus treated with esophagomyotomy. Digestion 1975;13:141-5. 30. Ellis F, Cole FL. Reflux after myotomy. Gut 1965;6:69-4. 31. Arvanitakis C. Achalasia of the esophagus: a reappraisal of esophagomytomy vs. forceful pneumatic dilatation. Dig Dis 1975;20:641-6.
1981;80:789-95
A Prospective Randomized Study Comparing Forceful Dilatation and Esophagomyotomy in Patients with Achalasia of the Esophagus ATTILA CSENDES, NICHOLAS VELASCO, ITALO BRAGHETTO, and ANA HENRIQUEZ Gastrointestinal Unit, Department of Surgery, University of Chile, Santiago, Chile
A prospective and randomized study was performed comparing pneumatic forceful dilatation and surgical esophagomyotomy as primary treatment of patients with achalasia of the esophagus. Eighteen dilated and 20 operated patients were studied before and after treatment with 1 patient lost. Clinical, radiologic, and manometric evaluations were performed before and after treatment and acid reflux test in the late follow-up period. Immediately after treatment, a significant improvement was seen clinically, by radiologic studies and after manometric evaluation. In the late follow-up period, operated patients showed a permanent improvement in all of them, but dilated patients remained a symptomatic in about 50% of the cases. The rest had to be redilated or reoperated on due to a failure of primary dilatation leading to final good or excellent results in 60% and failure in 40% of patients. Acid rej7ux test showed a positive test in 31% of the operated patients and in 7% of the dilated patients. This controlled study suggests that surgical treatment of achalasia, used as primary treatment, is accompanied by significantly better long-term results compared with pneumatic dilatation according to the technique utilized by us. The best actual treatment for achalasia of the esophagus is based on the destruction of muscle fibers at the gastroesophageal sphincter in order to obtain an adequate emptying of the esophagus. This goal can
Received May 27, 1980.Accepted November 21, 1980. Address requests for reprints to: Attila Csendes, M.D., Centro de Gastroenterologia, Hospital J. J. Acquirre, Santos Dumont 999, Santiago, Chile. We are grateful to Dr. Charles E. Pope II for his critical review of this manuscript. 0 1981 by the American Gastroenterological OOlS-5085/81/040789-07$02.50
Association
Hospital
Clinico Jose Joaquin Aguirre,
be achieved either by a forceful pneumatic dilatation (l-9) or by surgical esophagomyotomy (10-20). The long-term results obtained after these procedures have been published by several authors; there is no prospective randomized trial of the two methods. The purpose of the present study was to perform such a prospective and randomized clinical trial comparing the medical or surgical treatment in patients with achalasia treated by the same criteria and the same medical group in order to determine if there is a significative difference in the long-term results.
Material and Methods Thirty-eight consecutive patients were included in this prospective study, which began in January, 1973 and ended in July, 1979. All of them had either achalasia type I or II, i.e., mild or moderate esophageal dilatation seen in xray studies thus making them eligible for either treatment. Patients with severe “Sigmoid” dilatation of the esophagus were excluded from this study. Patients dilated or treated previously were not included. After completing clinical and laboratory studies, they were randomly assigned to two groups: A. Dilated group: Eighteen patients (12 females and 6 males) with a mean of 38 yr (range 15-73 yr). B. Operated group: 20 patients (11 females and 9 males) with a mean age of 42 yr (range 22-83 yr). All patients had serologic tests for Chagas disease. tests were positive in 5 cases (13%). In all patients the following studies were performed fore any treatment and in the final follow-up period:
The be-
1. Clinical analysis with careful attention to presence and duration of dysphagia, presence of heartburn, loss or
790
CSENDES ET AL.
gain of weight, regurgitation, and presence of pulmonary symptoms. Dysphagia was classified clinically as follows: (a) Mild dysphagia corresponded to patients in whom the bolus of meat or solids would stick occasionally, but not liquids. (b) Moderate dysphagia occurred when patients could take only minced foods. (c) Severe dysphagia meant that patients could tolerate liquids only. Radiologic studies in the upright position (not in recumbent position) with careful evaluation of two parameters in reviewed independently by two of the authors: (a) maximal internal diameter of the narrowed segment at the gastroesophageal junction during the flux of barium, and (b) maximal internal diameter of the middle third of the esophagus. Manometric studies with three polyethylene catheters (ID 1.4 mm) constantly perfused by a Harvard infusion pump at a rate of 2 ml/min. (21-23). The compliance of our system showed a presence rise time of 90 mmHg during l-s occlusion. Zero values represent end expiratory fundic pressure. All values are expressed in mmHg as mean -tSEM. Tracings were read and measured by the same author before and after treatment (A. Csendes) and were reviewed blindly by two other authors (N. Velasco and I. Brachetto). Acid reflux test was performed in the follow-up study by attaching a glass electrode (Pye Unicam) to the manometric assembly. This test was performed according to the method described previously (24). Pneumatic dilatation was done by the same author in all patients with a Mosher bug under fluoroscopic observation. Patients were premeditated with 0.5 mg of atropine and a slight pharyngeal anesthesia. Once the bag was placed in the correct position, it was inflated rapidly to 1215 lbs./in.‘, and when completely inflated, it remained so for 3-5 s, and this procedure was done two times. The maximal diameter of the Mosher bag, which was achieved at the gastroesophageal junction when completely inflated, was 5 cm. The duration for this procedure was 1 min. It was impossible for it to remain inflated more than 5 s, each time because all patients had intense pain and discomfort. When the balloon was removed, it always contained blood, which indicated some degree of mucosal
damage. All patients were hospitalized and were observed for 24 h, and then discharged. The full recovery period was 1 wk. Surgery was performed by the same author in all cases (A. Csendes). The surgical procedure was performed by a transabdominal route. After careful isolation of the abdominal esophagus and gastroesophageal junction, an anterior esophagomyotomy was performed according to Zaaijer’s technique (25) (Figures l-3). Five to 6 cm of the distal esophageal muscle fibers and not more than 5 mm of gastric muscle fibers were resectioned. If esophageal mucosa was accidentaly opened (in 4 cases), it was sutured with 3-O plain catgut. A fundic serosal patch was added in all patients for two reasons: as prevention of fistula development if mucosa has been opened and mainly because suturing the muscular edges to the serosal surface of the stomach offsets the possibility of future reaproximation of
GASTROENTEROLOGY
Vol. 80, No. 4
muscle fibers. The average hospital stay was 8 days (1 day before and 6-7 days after surgery). Students t-test for paired values was used for statistical analaysis of the data.
Results Clinical
Analysis
Operated group. Before treatment all patients had dysphagia and regurgitation with a mean duration of 4.4 yr. There was no operative mortality. Two patients had an important infection of laparotomy, and 1 of them had to be reoperated for left subphrenic abscesses. No postoperative fistula occurred in any patient. After surgery all patients became asymptomatic and gained weight. The total time lost from work and for complete convalescence from surgery was 4 wk. One patient died 6 mo after surgery. Nineteen cases were followed for a mean of 43 mo (range 1683 mo). Twelve were completely asymptomatic, and 7 had occasional mild dysphagia. All of them were happy with the surgical results. Two of them had mild heartburn (Table 1). Dilated group. Before treatment all patients had dysphagia and regurigitation of 2.7 yr. There were no complications after dilatation. Immediately after treatment patients became asymptomatic and gained weight. All were followed up with a mean duration of 42 mo (range 15-73 mo). Eight patients were asymptomatic (44%). Four patients had mode rate or severe dysphagia, but refused other treatment. Three patients were dilated again (2 of them one time and 1 in two occasions). After redilatation 2 of them still had mild dysphagia, and 1 was asymptomatic. Three patients had to be operated on due to severe, persistent dysphagia. None of the dilated patients had heartburn (Table 1).
Radiologic
Studies
Gastroesophageai junction. There was a significant increase in the diameter of the narrowed segment at the gastroesophageal junction after either treatment (Table 2) (p < 0.01). Operated patients had a larger diameter than the dilated patients. In this later group, patients with symptoms still had a narrow segment in the last follow-up period. Middle third of the esophagus. There was a significant decrease in the maximal internal diameter of the middle third of the thoracic esophagus after dilatation and operation (p < 0.01). Symptomatic patients had larger diameters than did asymptomatic patients (Table 2).
April
1981
Figure
DILATATION
1. Distance
of surgical
section
Figure
in esophagomyotomy
2. Section
of the muscle
and resection
layer
AND ESOPHAGOMYOTOMY
IN ACHALASIA
of the fat pad at the esophagogastric
of the esophagus
and cardia.
junction.
791
792
GASTROENTEROLOGY
CSENDES ET AL.
Vol. 80, No. 4
Figure 3. Suture of the fundic serosa to both muscular edges of the esophagus.
Manometric
Studies
Body of the esophagus. There were no significant differences in the amplitude of the contractile nonperistaltic waves of the esophageal body before and after treatment (Table 3). In all cases no peristaltic waves were recorded, and deglutitions induced 100% of simultaneous waves. None of the patients showed peristaltic waves after treatment. Resting intraesophageal pressure was above fundic pressure in all patients before treatment and became negative after treatment. Gastroesophageal sphincter pressure. OPERATED GROUP: Before surgery patients had a mean resting GESP of 30.3f 3.8 mmHg. In all of them a significant fall in sphincteric pressure was observed 1 mo after surgery with a mean value of 7.6 f 0.9 mmHg ( p < 0.001). In the late follow-up, sphincter pressure had a mean value of 8.4 f 1.3 mmHg. None of these cases had zero values for sphincter pressure, i.e., abscence of gastroesophageal sphincter pressure (Figure 4). DILATED GROUP: Before dilatation patients had a mean resting GESP of 30.0 f 3.1 mmHg. One month after dilatation there was a significant decrease in GESP with a mean value of 15.2 f 1.7 mmHg (p < 0.01). In the last follow-up period two groups were identified (Figure 5). Eight asympto-
matic patients showed no change in GESP with a mean resting value of 14.5 + 1.5 mmHg. Ten patients who were symptomatic or required further dilatation or operation showed no significant difference in resting GESP values before treatment, compared with the last follow-up period. Acid Reflux Test Operated group: This test was performed in of 19 patients. It was positive in 5 (31%) and negative in 11. Only 2 patients of the positive test group had mild heartburn. Dilated group. The acid reflux test was performed in 15 of 18 patients, and it was positive in only 1 patient (7%). None of them had heartburn. 16
Table 1.
Clinical Results in the Randomized Study
Operated = 20 (1 lost) 12 Asymptomatic 7 With mild dysphagia 2 With heartburn
Dilated = 18 8 4 3 3 0
Asymptomatic Moderate or severe dysphagia Redilated Operated Heartburn
April 1981
Table
2.
DILATATION AND ESOPHAGOMYOTOMY
Radiologic
Studies
Gastroesophageal junction (mm) Before Treatment Late follow-up period Middle third of the esophagus (mm) Before Treatment Late follow-up period
Dilatation
Operation
2.6 f 0.4
2.2 f 0.2
6.6 f 0.6
8.5 f 0.5
46.5
f
1.7
29.6 f 0.2
50.5 f 2.6 27.5
f
1.6
Discussion The results of this prospective and randomized study comparing pneumatic dilatation or esophagomyotomy as treatment of achalasia of the esophagus suggest that significantly better, longterm results can be obtained after surgical esophagomyotomy than after forceful dilatation. There is no doubt that the definitive treatment for achalasia is based on the section of the muscle fibers at the gastroesophageal junction either by pneumatic dilatation or esophagomyotomy. Other methods like anticholinergics, dilatation by mercuryfilled bougies, cardioplasty, or esophagogastrectomy are unsuccesful, with a high recurrence rate (14-26). Several authors in retrospective studies have favored pneumatic dilatation as the primary treatment for achalasia. Clinical and radiologic follow-up of patients treated by this method have reported excellent or good results in 70%-75% of the cases (l-9, 27), figures higher than our results. The advantage of this method is that it is a rapid procedure, with no more than 1 day hospitalization, as in our cases, and it avoids a surgical procedure. However several disadvantages can be mentioned: (a) The perforation rate of the esophagus reported by many authors is between 2% and 6% although the 1974 ASGE study reported perforation rate was 1%. (b) The way to obtain the rupture or section of the muscle fibers is from inside the lumen to outside, which means some degree of rupture of the mucosa and incomplete and “blind” section of the circular muscular layer. Therefore, there is no way to control the magnitude
Table
3.
Manometric Esophagus
Features
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793
of this section. In our dilated group, we obtained with our method final results that were either good or excellent in 60% (11 patients) and failures in 40% (7 patients). It is possible that the appearance or persistence of dysphagia in these patients could be partly due to some mechanical factor, maybe produced by an intramural hematoma and subsequent fibrosis caused by the sudden rupture of the circular muscle of the distal esophagus by the dilator bag. This was clearly seen in the 3 patients who had to be operated on due to failure of dilatation. In them, the distal esophagus was firm and fibrous, and it was very difficult to separate the muscular layer from the mucosa clearly, by careful dissection. In all of them, in order to achieve a complete muscular section, the mucosal layer had to be opened. In the last year several publications have favored surgical treatment for achalasia (lo-20,28). Different authors, including us, have reported good or excellent results in over 80% of all operated patients (29). However, the disadvantages of this method are that patients are submitted to surgical risk (which is minimum), some degree of complications can occur, and several days of hospitalization are necessary, In addition, the incidence of gastroesophageal reflux is variable, from 5% to 50% (14,16,17,19,20,29). However, several advantages can be reported: (a) The section of the muscle fibers is done under direct vision; therefore, a very careful treatment can be performed. (b) If a malignant tumor is discovered, it is treated immediately. And (c) if there is another abdominal disease, it can be treated. In the assessment of these results, it can be argued that the application of these methods of treatment, dilatation and specially surgical procedure, requires a good deal of expertise, and the methods used are also different, and therefore conclusions could be EFFECT GESP cmmtfg
) 70 60 i
OF ESOPHAGOMYOTOMY 20 PATIENTS
-) prcop- poslop and 9 1
-
preop
proscnl
and present
of the Body of the
Dilatation Amplitude waves (mmHg) of Nonperistaltic contractions Before treatment 29.4 f 5.2 Late follow-up period 31.7 f 5.3 Intraesophageal resting pressure (mmHg) Before Treatment + 5.6 Late follow-up period -1.7
Operation
25.9 f 4.1 23.7
f 2.8
+ 6.4 -3.6
Figure
4.
Effect of esophagomyotomy sphincter pressure (GESP).
on
gastroesophageal
794
CSENDES
ET AL.
GASTROENTEROLOGY
EFFECT
OF
PNEUMATIC 18 PATIENIS
GESP rmmtfg,, 70
Vol. 80, No. 4
DILATATION
G,ESP rmmHg, 704 1
60 i
Figure
5. Effect of pneumatic esophageal sphincter
dilatation pressure
WELL
AFTER
I DILATATION
=8
60-
NOT WELL AFTER
I DlLAlATlON.=lO
on Gastro(GESP).
valid only for the individual operator. It is probable that to some degree physician’s expertise can influence the widely different results reported in the literature on the two different methods. Accordingly, this argument could invalidate any clinical trial. It is obvious that every physician or surgeon has some special details when performing a technique, which leads to minor differences from one author to another. However, the main principles are the same, and those are what we are comparing: pneumatic dilatation and esophagomyotomy. Gastroesophageal reflux can be avoided by careful surgical technique. The incision in the esophagus must be long enough (5-6 cm) to assure a complete section and adequate esophageal emptying. In the stomach it must be placed in the lesser curve of the stomach so that reflux is likely to be diminished. We prefer a single, longitudinal myotomy limited to the esophagus, and not more than 5-10 mm to the lesser curve of the stomach, because in this way a residual sphincter activity is left, as was observed in all our patients. More radical incisions, especially 2 cm or more of the stomach, as has been advocated by some authors, may lead to a high percentage of reflux (1920) due to complete section of the gastric sling fibers. With our surgical technique, we have observed a 30% incidence of esophageal reflux, mostly asymptomatic. We have not observed severe gastroesophageal reflux and stricture with this surgical technique. We find little reason to transsect more than 5 mm of the muscular coat of the stomach, because the gastric musculature plays little role in the obstructive mechanism seen in achalasia, but an intact band at the gastroesophageal junction may leave residual constriction and may permit herniation of the mucosa, leading to an epiphrenic type of diverticulum. The decrease in sphincter pressure is permanent after this surgical technique, as can be seen in our
patients. This residual sphincter activity may explain the low incidence of gastroesophageal reflux. Our study confirms a previous publication of a retrospective study by Arvanitakis (31) and by Yon and Christensen (26). The latter authors reported 85% good results after esophagomyotomy and 46% after dilatation, values very similar to ours. However, they ascribe the poor results of forceful dilatation to the fact that the dilatations were carried out by different physicians. Arvanitakis reported 65% good results after dilatation and 91% after esophagomyotomy. Both publications report gastroesophageal reflux in a similar percentage to ours. After treatment, adequate emptying is obtained from the esophagus, but esophageal aperistalsis is not changed in our patients. It is not clear why no return to peristalsis was observed in any of our patients, as was observed by Vantrappen et al. (8). In summary, in this prospective controlled trial, we have obtained significantly better long-term results in patients with achalasia of the esophagus when treated surgically than when submitted to forceful dilatation according to our technique.
References 1. Bennett JR, Bargaza E, Hendrix JR, Siegel CF. Treatment of achalasia by pneumatic dilatation of the cardia. Gut 1968;9:727-31. 2. Heitmann P, Wienbeck M. The immediate effect of successful pneumatic dilatation on esophageal function in achalasia. Stand J Gastroenterol 1972;7:197-294. DJ, Raskin HF, Kirsner JB, Palmer WL. Therapeutic 3. Kurlander value of the pneumatic dilatation in achalasia of the esophagus. Gastroenterology 1963;45:664-13. EM. Treatment of the achalasia of the cardia. Gastro4. Nanson enterology 1966;51:236-41. AM, Harrington SW, Moersch HJ, Andersen HA. The 5. Olsen
April 1961
6.
7.
6.
9. 10.
11.
12. 13. 14.
15.
16.
17.
DILATATION AND ESOPHAGOMYOTOMY
treatment of cardiospasm, analysis of twelve years experience. J Thorac Cardiovasc Surg 1951;22:164-67. Sanderson DR, Ellis HF, Olsen AL. Achalasia of the esophagus, results of therapy by dilatation 1950-1967. Chest 1970; 56:116-21. Van Giodsenhoven GE, Vantrappen G, Verbeke S, Vandenbroucke J. Treatment of achalasia of the cardia with pneumatic dilatations. Gastroenterology 1963;45:326-34. Vantrappen G, Giodsenhoven GE, Verbeke S, et al. Manometric studies in achalasia of the cardia before and after pneumatic dilatations. Gastroenterology 1963;45:317-25. Vantrappen G, Hellemans J, Deloof W, et al. Treatment of achalasia with pneumatic dilatations. Gut 1971;12:266-75. Ellis FH, Olsen AM, Holman CB, Code CE. Surgical treatment of cardiospasm (achalasia of the esophagus). JAMA 1956; X6:29-36. Jara FM, Toledo-Pereira LH, Lewis JW, Magilligan DJ. Long term results of esophagomyotomy for achalasia of the esophagus. Arch Surg 1979114935-6. Rees JR, Thorbynarson B, Barnes WH. Achalasia: results of operation in 64 patients. Ann Surg 1970;171:195-201. Payne WS, Ellis FH. Olsen AM. Achalasia of the esophagus. Arch Surg 1969;61:91-6. Sawyers JL, Foster JH. Surgical considerations in the management of the achalasia of the esophagus. Ann Surg 1967; 165:76CI-5. Hawthorne HR, Frobese AS, Nemir P. The surgical management of achalasia of the esophagus. Ann Surg 1956;144:65369. Menzies Gow J, Gummer JWP, Edwards DAW. Results of Heller’s operation for achalasia of the cardia. Br J Surg 1976;65:463-5. Ellis FH, Kiser JC, Schlegel JF, et al. Esophagomyotomy for achalasia of the esophagus. Ann Surg 1967;166:646-56.
IN ACHALASIA
795
16. Wingfield MV, Karwowski A. The treatment of achalasia by cardiomyotomy. Br J Surg 1972;59:261-4. 19. Effler DB, Loop F, Groves LK, Favaloro AG. Primary surgical treatment for esophageal achalasia. Surg Gynecol Obstet 1971;132:1057-63. 20. Rapant V, Kralik J. Heller’s radical myotomy in the treatment of achalasia of the esophagus. Sot lnt Chir 1966;8:656-62. 21. Heitmann P, Espinoza J. Csendes A. Phisiology of the distal esophagus in achalasia. Stand J Gastroenterol 1969;4:1-11. 22. Csendes A, Larrain A. Effect of posterior gastropexy on gastroesophageal sphincter pressure and symptomatic reflux in patients with hiatal hernia. Gastroenterology 1972;63:19-24. 23. Uribe P, Csendes A, Larrain A, Ayala M. Motility studies in fifty patients with achalasia of the esophagus. Am J Gastroenterol 1974;62:333-6. 24. Csendes A, Oster M, Moller J, et al. Gastroesophageal reflux in duodenal ulcer patients before and after vagotomy. Ann Surg 1976;168:694-6. 25. Zaaijer JH. Cardiospasm in the aged. Ann Surg 1923;77:615-7. 26. Yon J, Christensen J. An uncontrolled comparison of treatment for achalasia. Ann Surg 1975;162:672-6. 27. Csendes A, Strauszer T. Long term clinical, radiological and manometric follow up period of patients with achalasia treated with pneumatic dilatation. Digestion 1974;11:126-34. 26. Clagett OT. Achalasia: dilatation or myotomy? J Thorac Cardiovasc Surg 1967;53:757-6. 29. Csendes A, Larrain A, Strauszer T, Ayala M. Long term clinical, radiological and manometric follow up period of patients with achalasia of the esophagus treated with esophagomyotomy. Digestion 1975;13:141-5. 30. Ellis F, Cole FL. Reflux after myotomy. Gut 1965;6:69-4. 31. Arvanitakis C. Achalasia of the esophagus: a reappraisal of esophagomytomy vs. forceful pneumatic dilatation. Dig Dis 1975;20:641-6.