Journal of Surgical Oncology 7:411-414 (1975)
Vagotomy - A Prospective, Randomized Study .......................................................................................... .......................................................................................... C . T. BOMBECK, M.D., F.A.C.S., R. E. CONDON, M.D., M.S., F.A.C.S., and L. M. NYHUS, M.D., F.A.C.S. This is a report of a prospective randomized study of 3 operations for duodenal ulcer; parietal-cell vagotomy alone (without drainage), selective vagotomy with antrectomy, and truncal vagotomy with antrectomy. All patients in the study have been followed for a minimum of 1 yr and despite the small number of patients (total 23 in this report), there has been a statistically significant return of gastric secretory activity to preoperative levels in the parietal cell vagotomy group, while both other groups maintained decreased acid secretion at the 1-yr period. To date there has been one recurrent ulcer and one other suspected ulcer in the parietal cell vagotomy group, while both other groups have no ulcer recurrence even though morbidity has been higher (bile reflux gastritis, and so forth). This preliminary evaluation suggests strongly that extreme caution be used in applying parietal-cell vagotomy alone as a definitive operation for duodenal ulcer, b u t because of the small number of patients involved n o conclusions can be drawn at this time.
.......................................................................................... .......................................................................................... KEY WORDS: parietal cell vagotomy, duodenal ulcer
Vagotomy, supposedly limited to the parietal cell mass, is rapidly gaining a reputation as the surgical panacea for duodenal ulcer. Although it is known by many names, we prefer to use “Parietal Cell Vagotomy” or “PCV” to describe the operation by referring to its purpose. Since the initial description of the operation in man by Holle and Hart in 1967 (l), there have been many reports of series of patients undergoing this operation for either duodenal or gastric ulcers, or combinations of the two. As has been common in the field, no report has appeared contrasting this new operation (PCV) with other, more standard, duodenal ulcer procedures. In order to evaluate more critically this procedure, we began a prospective randomized study of PCV without drainage, contrasted with truncal vagotomy plus antrectomy (TV&A), and selective vagotomy and antrectomy (SV&A).
MATERIALS AND METHODS As soon as it seemed likely that a patient was a candidate for the study, the option of participating in it was offered to him. If he accepted, he underwent preoperative measurements of gastric basal acid secretion and maximal acid output (MAO), measured West Side Veterans Adminstration Hospital, Chicago, and Department of Surgery, University of Illinois, Abraham Lincoln School of Medicine. Address reprint requests t o D. C. Thomas Bombeck, University of Illinois a t the Medical Center, Abraham Lincoln School of Medicine, Department of Surgery, P.O. Box 6998, Chicago, Illinois 60680. 411 @ 1975 Alan R. Liss, Inc., 1 5 0 F i f t h Avenue, New York, N.Y. 10011
412
Bombeck, Condon, and Nyhus
with the augmented histamine test. He also had measurements of gastric emptying time made radiologically, and if he emptied a standard meal - two slices of fresh bread with two cups of barium suspension - in from two to four hours, he was considered a candidate. The usual indication for operation was the presence of an intractable duodenal ulcer. The patient was taken to the operating room and explored through a midline incision. The caliber of the pyloric channel was determined by passage of graded dilators through the pylorus through a small gastrostomy or by withdrawal of a previously calibrated water-filled balloon, passed per os, from the duodenum through the pylorus. We have recently substituted gastroduodenoscopy for both these methods. The minimal acceptable caliber of the pylorus was 1.5 cm. If the pyloric channel was adequate, a card randomized according to a computergenerated random-number table was pulled from a sealed file to which the operating surgeon did not have previous access. The card designated the operation to be performed. The technique of PCV was as previously described by us (2). TV&A and SV&A were carried out by standard techniques except that no special methods were used to outline the gastric antrum. Complete antrectomy was verified by subsequent histologic examination of the margins of the resected specimen. At 6 weeks and 1 yr postop, all patients underwent postoperative secretory testing by the same methods used preoperatively, and at 6 months postop, measurements of gastric emptying were made by the same radiologic methods used previously. All patients were interviewed for symptoms of dumping, recurrent ulcer, or postvagotomy diarrhea by an observer (registered nurse) using a questionnaire. The observer had no knowledge of the operation performed. Only if the patient exhibited any unusual or disabling symptoms was he examined in depth by one of the authors. Of necessity, the patient’s operation was identified at that time. Of the 34 patients available for study, only 2 1 completed the entire course of study due to the transient and unstable nature of our patient population.
RESULTS The secretory findings in the remaining 21 patients are presented in Table 1. TABLE 1.
Gastric Acid Secretion (mEq/hr) in Patients Following Vagotomy Selective vagotomy and antrectomy
Truncal vagotomy and antrectomy
Parietal cell vagotomy ~
Basal
S tirnulated
Morbidity Rate
Preop 6-wk Postop 1-yrPostop
6.53 0.35 0.19
i
Preop 6-wk Postop 1-yr Postop
30.57 2.48 1.87 3/9*
f i
i f
2
2.07 0.22 0.10
6.43 i 2.72 0.94 r 0.66 0.89 r 0.43
6.13 2.19 4.93
4-.19 0.43 0.68
22.34 i 3.88 1.71 r 0.45 3.02 r 2.38 014
25.55 11.25 19.06 I/8t
*Includes one patient with severe dumping requiring operation.
t Ulcer recurrence.
t
*
* t
i i
1.59 0.64 1.94 2.61 2.34 4.06
413
Vagotomy
Although basal and MA0 decreased markedly by the 6-wk period in all patients, and all decreases were statistically significant, it is notable that the PCV group had almost complete return of both basal and MA0 to 80%and 75% of preop values by one year. Corresponding values for TV&A are 14% basal and 14%MA0 and for SV&A are 3%basal and 6%MAO. The increases for PCV are highly statistically significant (p < .OOl), contrasted with either TV&A or SV&A. Several patients from each group had both basal and meal-stimulated serum gastrins determined postoperatively by radioimmunoassay. Serum gastrin levels did not differ between groups basally and all values fell within the normal range for our laboratories. Meal-stimulated gastrin levels were muchhigher in the TV&A group than in either the SV&A or PCV groups, but these values were widely divergent and not statistically significant at this time. Gastric emptying was not changed from preop in any group of patients, except for the one severe dumper in the SV&A group. He eventually required a reversed Herrington loop interposition and is now doing well. No patient in any group developed significant diarrhea or signs of dysphagia or gastroesophageal reflux. Although 2 other patients in the SV&A group now have symptoms of biliary gastritis, confirmed by endoscopy, neither of these cases is severe. It is of interest that 2 of 6 patients following truncal vagotomy have developed gallstones while no patients in other groups have this finding. Although suggestive, the significance of this occurrence remains to be explained. One patient in the PCV group has developed a confirmed recurrent ulcer. From his symptomatic history, it is doubtful that his ulcer ever healed postoperatively. At this writing, another has symptoms suggestive of ulcer although repeated duodenoscopy has failed to confirm this finding.
DISCUSSION The primary finding presented in this study is that PCV. performed according to the method of Holle and Hart, has failed to significantly reduce gastric acid hypersecretion in duodenal ulcer patients on long-term follow-up. That this is biologically significant is suggested by the initial appearance of at least one recurrent ulcer in the PCV group. Most other groups in this area report results significantly different from those presented here (3). One exception is the data of Wastell (4) in which the ulcer recurrence rate in the PCV group without drainage was similar to our own. The only explanation for the discrepancy observed herein must lie with the degree of vagal denervation of the stomach achieved by the technique we employ, compared with the techniques of other investigators. The upper extent of our vagotomy surrounds the esophagus but the lower extent divides only half of the ramifications of the nerves of Latarget on the antrum. A greater degree of vagal section than this would result in the same degree of vagotomy achieved by standard selective vagotomy. It is known that that procedure does preserve some degree of antral and pyloric innervation. In summary, PCV must still be considered an experimental operative procedure of unproven mechanism and with questionable results. Until the technique is standardized and long-term follow-up of large random series carried out, the operation should not be applied to the routine clinical situation.
414
Bornbeck, Condon, and Nyhus
REFERENCES 1. Holle, F., and Hart, W. Neue Wege der Chirurgie des Gastroduodenal Ulcus. Med. Klin. 62:441, 1967. 2. Miller, B., Bornbeck, C. T., Schurner, W., Condon, R. E., and Nyhus, L. M. Vagotomy Limited t o the Parietal Cell Mass. Arch. Surg. 103: 153-157, 1971. 3. Johnston, D. A New Look a t Vagotomy, pp. 125-160. L. M. Nyhus (ed.): “Surgery Annual 1974.” New York City: Appleton-Century-Crofts, 1974. 4. Wastell, C., Colin, J. F., and MacNaughton, J. D. Selective Proximal Vagotomy with and without Pyloroplasty. Brit. Med. J. 1:28-30, 1972.
Vagotomy - A Prospective, Randomized Study .......................................................................................... .......................................................................................... C . T. BOMBECK, M.D., F.A.C.S., R. E. CONDON, M.D., M.S., F.A.C.S., and L. M. NYHUS, M.D., F.A.C.S. This is a report of a prospective randomized study of 3 operations for duodenal ulcer; parietal-cell vagotomy alone (without drainage), selective vagotomy with antrectomy, and truncal vagotomy with antrectomy. All patients in the study have been followed for a minimum of 1 yr and despite the small number of patients (total 23 in this report), there has been a statistically significant return of gastric secretory activity to preoperative levels in the parietal cell vagotomy group, while both other groups maintained decreased acid secretion at the 1-yr period. To date there has been one recurrent ulcer and one other suspected ulcer in the parietal cell vagotomy group, while both other groups have no ulcer recurrence even though morbidity has been higher (bile reflux gastritis, and so forth). This preliminary evaluation suggests strongly that extreme caution be used in applying parietal-cell vagotomy alone as a definitive operation for duodenal ulcer, b u t because of the small number of patients involved n o conclusions can be drawn at this time.
.......................................................................................... .......................................................................................... KEY WORDS: parietal cell vagotomy, duodenal ulcer
Vagotomy, supposedly limited to the parietal cell mass, is rapidly gaining a reputation as the surgical panacea for duodenal ulcer. Although it is known by many names, we prefer to use “Parietal Cell Vagotomy” or “PCV” to describe the operation by referring to its purpose. Since the initial description of the operation in man by Holle and Hart in 1967 (l), there have been many reports of series of patients undergoing this operation for either duodenal or gastric ulcers, or combinations of the two. As has been common in the field, no report has appeared contrasting this new operation (PCV) with other, more standard, duodenal ulcer procedures. In order to evaluate more critically this procedure, we began a prospective randomized study of PCV without drainage, contrasted with truncal vagotomy plus antrectomy (TV&A), and selective vagotomy and antrectomy (SV&A).
MATERIALS AND METHODS As soon as it seemed likely that a patient was a candidate for the study, the option of participating in it was offered to him. If he accepted, he underwent preoperative measurements of gastric basal acid secretion and maximal acid output (MAO), measured West Side Veterans Adminstration Hospital, Chicago, and Department of Surgery, University of Illinois, Abraham Lincoln School of Medicine. Address reprint requests t o D. C. Thomas Bombeck, University of Illinois a t the Medical Center, Abraham Lincoln School of Medicine, Department of Surgery, P.O. Box 6998, Chicago, Illinois 60680. 411 @ 1975 Alan R. Liss, Inc., 1 5 0 F i f t h Avenue, New York, N.Y. 10011
412
Bombeck, Condon, and Nyhus
with the augmented histamine test. He also had measurements of gastric emptying time made radiologically, and if he emptied a standard meal - two slices of fresh bread with two cups of barium suspension - in from two to four hours, he was considered a candidate. The usual indication for operation was the presence of an intractable duodenal ulcer. The patient was taken to the operating room and explored through a midline incision. The caliber of the pyloric channel was determined by passage of graded dilators through the pylorus through a small gastrostomy or by withdrawal of a previously calibrated water-filled balloon, passed per os, from the duodenum through the pylorus. We have recently substituted gastroduodenoscopy for both these methods. The minimal acceptable caliber of the pylorus was 1.5 cm. If the pyloric channel was adequate, a card randomized according to a computergenerated random-number table was pulled from a sealed file to which the operating surgeon did not have previous access. The card designated the operation to be performed. The technique of PCV was as previously described by us (2). TV&A and SV&A were carried out by standard techniques except that no special methods were used to outline the gastric antrum. Complete antrectomy was verified by subsequent histologic examination of the margins of the resected specimen. At 6 weeks and 1 yr postop, all patients underwent postoperative secretory testing by the same methods used preoperatively, and at 6 months postop, measurements of gastric emptying were made by the same radiologic methods used previously. All patients were interviewed for symptoms of dumping, recurrent ulcer, or postvagotomy diarrhea by an observer (registered nurse) using a questionnaire. The observer had no knowledge of the operation performed. Only if the patient exhibited any unusual or disabling symptoms was he examined in depth by one of the authors. Of necessity, the patient’s operation was identified at that time. Of the 34 patients available for study, only 2 1 completed the entire course of study due to the transient and unstable nature of our patient population.
RESULTS The secretory findings in the remaining 21 patients are presented in Table 1. TABLE 1.
Gastric Acid Secretion (mEq/hr) in Patients Following Vagotomy Selective vagotomy and antrectomy
Truncal vagotomy and antrectomy
Parietal cell vagotomy ~
Basal
S tirnulated
Morbidity Rate
Preop 6-wk Postop 1-yrPostop
6.53 0.35 0.19
i
Preop 6-wk Postop 1-yr Postop
30.57 2.48 1.87 3/9*
f i
i f
2
2.07 0.22 0.10
6.43 i 2.72 0.94 r 0.66 0.89 r 0.43
6.13 2.19 4.93
4-.19 0.43 0.68
22.34 i 3.88 1.71 r 0.45 3.02 r 2.38 014
25.55 11.25 19.06 I/8t
*Includes one patient with severe dumping requiring operation.
t Ulcer recurrence.
t
*
* t
i i
1.59 0.64 1.94 2.61 2.34 4.06
413
Vagotomy
Although basal and MA0 decreased markedly by the 6-wk period in all patients, and all decreases were statistically significant, it is notable that the PCV group had almost complete return of both basal and MA0 to 80%and 75% of preop values by one year. Corresponding values for TV&A are 14% basal and 14%MA0 and for SV&A are 3%basal and 6%MAO. The increases for PCV are highly statistically significant (p < .OOl), contrasted with either TV&A or SV&A. Several patients from each group had both basal and meal-stimulated serum gastrins determined postoperatively by radioimmunoassay. Serum gastrin levels did not differ between groups basally and all values fell within the normal range for our laboratories. Meal-stimulated gastrin levels were muchhigher in the TV&A group than in either the SV&A or PCV groups, but these values were widely divergent and not statistically significant at this time. Gastric emptying was not changed from preop in any group of patients, except for the one severe dumper in the SV&A group. He eventually required a reversed Herrington loop interposition and is now doing well. No patient in any group developed significant diarrhea or signs of dysphagia or gastroesophageal reflux. Although 2 other patients in the SV&A group now have symptoms of biliary gastritis, confirmed by endoscopy, neither of these cases is severe. It is of interest that 2 of 6 patients following truncal vagotomy have developed gallstones while no patients in other groups have this finding. Although suggestive, the significance of this occurrence remains to be explained. One patient in the PCV group has developed a confirmed recurrent ulcer. From his symptomatic history, it is doubtful that his ulcer ever healed postoperatively. At this writing, another has symptoms suggestive of ulcer although repeated duodenoscopy has failed to confirm this finding.
DISCUSSION The primary finding presented in this study is that PCV. performed according to the method of Holle and Hart, has failed to significantly reduce gastric acid hypersecretion in duodenal ulcer patients on long-term follow-up. That this is biologically significant is suggested by the initial appearance of at least one recurrent ulcer in the PCV group. Most other groups in this area report results significantly different from those presented here (3). One exception is the data of Wastell (4) in which the ulcer recurrence rate in the PCV group without drainage was similar to our own. The only explanation for the discrepancy observed herein must lie with the degree of vagal denervation of the stomach achieved by the technique we employ, compared with the techniques of other investigators. The upper extent of our vagotomy surrounds the esophagus but the lower extent divides only half of the ramifications of the nerves of Latarget on the antrum. A greater degree of vagal section than this would result in the same degree of vagotomy achieved by standard selective vagotomy. It is known that that procedure does preserve some degree of antral and pyloric innervation. In summary, PCV must still be considered an experimental operative procedure of unproven mechanism and with questionable results. Until the technique is standardized and long-term follow-up of large random series carried out, the operation should not be applied to the routine clinical situation.
414
Bornbeck, Condon, and Nyhus
REFERENCES 1. Holle, F., and Hart, W. Neue Wege der Chirurgie des Gastroduodenal Ulcus. Med. Klin. 62:441, 1967. 2. Miller, B., Bornbeck, C. T., Schurner, W., Condon, R. E., and Nyhus, L. M. Vagotomy Limited t o the Parietal Cell Mass. Arch. Surg. 103: 153-157, 1971. 3. Johnston, D. A New Look a t Vagotomy, pp. 125-160. L. M. Nyhus (ed.): “Surgery Annual 1974.” New York City: Appleton-Century-Crofts, 1974. 4. Wastell, C., Colin, J. F., and MacNaughton, J. D. Selective Proximal Vagotomy with and without Pyloroplasty. Brit. Med. J. 1:28-30, 1972.
