Endoscopic sphincterotomy in the management of biliary tract disease MARIO F. CASTELLI, MD, FRCP[C]; BRIAN O'MALLEY, MB, FRCP[C]; SHIA SALEM, MD, FRCP[C]
The first electrosurgical endoscopic sphincterotomies of the ampulla of Vater for the removal of common bile duct stones were performed about 4 years ago in Japan and 14 In preliminary studies Kawai and associates1 had performed the operation in dogs. Since the introduction of this technique it has proved to be a safe, effective procedure in elderly, frail patients who are unfit for conventional surgical procedures. Even in younger patients the short-term morbidity and mortality, compared with the rates for conventional procedures, are appreciably less, and the technique is gaining wider acceptance. In this paper we describe the technique and report our first 26 cases in which it was attempted; in 21 instances it was successful. Patients and methods
All patients referred to the gastrointestinal service of Henderson General Hospital, Hamilton, with a diagnosis of choledocholithiasis or papillary stenosis with associated biochemical evidence of cholestasis were considered for endoscopic sphincterotomy. Patients without a previous cholecystectomy were referred for conventional surgical intervention unless they were considered to be at high surgical risk. Informed consent was obtained for endoscopic sphincterotomy from the 27 patients or their relatives. A comFrom the departments of medicine and radiology, Henderson General Hospital, Hamilton Reprint requests to: Dr. Mario F. Castelli, Medical Arts Building, 1 Young St., Hamilton, Ont. L8N 1T8
plete blood count and a platelet count were done and the prothrombin and partial thromboplastin times were determined in all patients. When coagulation abnormalities were found they were corrected before the procedure was undertaken. Patients with acute pancreatitis had the procedure deferred until 2 weeks after resolution of the acute pancreatitis. Patients with acute ascending cholangitis were referred for emergency sphincterotomy. Most of the patients were elderly; the average age was 74 years (range 39 to 95 years). Nineteen of the patients were women. All 27 complained of abdominal pain, 23 had a history of jaundice and 14 had jaundice at the time of referral. Nineteen patients had had a cholecystectomy previously. The serum alkaline phosphatase value was elevated in 23 and the serum amylase value was elevated in 5. With an Olympus JF-B2 fibreoptic
ally performed 1 week after the
sphincterotomy. Results Table I tabulates our results. En-
doscopic sphincterotomy was successful in 21 (81 %) of the 26 patients in whom it was attempted. The 21 patients were subsequently free of pain, jaundice and ascending cholangitis. There were no deaths that could be directly related to the procedure. Choledocholithiasis Of 22 patients who were referred because of choledocholithiasis 17 were free of stones in the common bile duct at the time of follow-up ERCP. Two patients refused followup ERCP, but their stones may have passed spontaneously since they were asymptomatic at the time of followup assessment. The rate of success for endoscopic sphincterotomy in this group was 86%. The procedure was successful side-viewing duodenoscope, endo- in all but two of the patients in whom scopic retrograde cholangiopancrea- ERCP was successful; one patient, tography (ERCP) was performed in who was asymptomatic at the time the standard fashion. A sphinctero- of follow-up assessment, had a stone tome developed by Classen and Dem- in the common bile duct that proved ling4 and modified by Safrany7 (Fig. too large to remove by any means, 1) was introduced into the common including surgical choledochoduodebile duct (Fig. 2); the sphincterotome nostomy (endoscopic sphincterotomy wire was then bowed open and a was attempted but was inadequate). blended coagulating-cutting current The procedure also failed in an used to unroof the papilla (Fig. 3). 85-year-old woman who presented We used a Cammeron-Miller coagu- with ascending cholangitis. She unlator unit (model 80-7960, Cam- derwent cholecystostomy but retained meron-Miller Surgical Instruments stones in the common bile duct. BeCompany, Chicago). The common cause of a large duodenal diverticubile duct stones were then extracted lum endoscopic sphincterotomy was with a dormia-type basket (Figs. 1 unsuccessful. The patient had recurand 4) or left to pass spontaneously rent attacks of ascending cholangitis (Fig. 5). Follow-up ERCP was usu- and died 3 weeks later.
1204 CMA JOURNAL/NOVEMBER 18, 1978/VOL. 119
In one 80-year-old woman who presented with ascending cholangitis endoscopic sphincterotomy was not attempted because ERCP was unsuccessful. Papillary stenosis Five patients were referred for endoscopic sphincterotomy because of papillary stenosis; ERCP was successful in all five when the catheter was jammed into the papillary orifice. In two patients the procedure was successful and they are now free of pain, jaundice and ascending cholangitis; follow-up ERCP demonstrated
JK. A ,...-J.e4.
II
I
a decrease in the size of the common bile duct. In three patients the procedure was attempted early in our experience and failed; the three did not have biochemical evidence of cholestasis, and so would not meet our current criteria for undergoing endoscopic sphincterotomy. If evidence of cholestasis develops, the procedure will be attempted again or they will be referred for a conventional operation. Complications Bleeding and ascending cholangitis: A 71-year-old man presented
- -. -.
Discussion
FIG. 1-Left: open sphincterotome. Centre and right: baskets for removing stones from common bile duct.
FIG. 2-Sphincterotome being introduced into common bile duct through ampulla of Vater.
with ascending cholangitis. He had previously had a cholecystectomy, and 7 years before presentation had undergone surgical sphincteroplasty. ERCP and endoscopic sphincterotomy were performed through the sphincteroplasty, which was scarred to such a degree that passage of the sphincterotome was difficult. The sphincterotomy was 1.5 cm in diameter, but moderate bleeding made complete removal of sludge and stones from the common bile duct impossible. The bleeding stopped after the transfusion of 2 units of whole blood. The patient was discharged from hospital, but presented 1 week later with ascending cholangitis. Concretions remaining in the common bile duct were removed surgically; the lower common bile duct was widely patent. At the time this report was written the patient had been asymptomatic for 6 months. Transient paralytic ileus: One patient had a huge stone in the common bile duct that passed spontaneously, but transient paralytic ileus developed 5 days after endoscopic sphincterotomy was performed. This may have been due to transient gallstone ileus since the patient had abdominal pain 4 days after endoscopic sphincterotomy was performed, which suggests passage of the stone from the common bile duct.
FIG. 3-Unroofed papilla after sphincterotomy.
The procedure we have described was pioneered in Japan and Germany'. and has been introduced in the United States.7-10 It has proven to be a very safe, effective and economical alternative to conventional surgical treatment of choledocholithiasis, ampullary stenosis and ampullary carcinoma. In compiled series good results have been reported in up to 96% of cases.2 Our experience with the treatment of choledocholithiasis is comparable, the success rate for the procedure being 86%, but we had more difficulty with papillary stenosis and were successful in treating only two of the five patients with this condition. With increasing experience our rate of success in treating papillary stenosis by means of endoscopic sphincterotomy will likely improve. Bleeding from the sphincterotomy site, acute pancreatitis, cholangitis, duodenal perforation and instrument
CMA JOURNAL/NOVEMBER 18, 1978/VOL. 119 1205
injury (e.g., trapping of the dormia basket in the common bile duct) have been reported as complications of endoscopic sphincterotomy.2'7 The mortality was 1.2% and 0.8% in the series by Safrany7 and Koch and colleagues2 respectively, as compared with an average surgical mortality of 4.2% for transduodenal 4rttaI sphincterotomy." In our series the 11 mwpeth3.#U. only complication related to the procedure was mild bleeding necessitating the transfusion of 2 units of endoscopic sphincterotomy. blood; in this patient ascending choland colleagues2 re-examined angitis occurred 1 week after the pro- 170Koch patients after endoscopic cedure. In another patient transient sphincterotomy1 year was and gallstone ileus occurred 5 days after found restenosis in 2 performed patients. They suggested that cholecystectomy might not be necessary after endoscopic sphincterotomy in patients at high risk. Four of their patients were found to have passed gallstones and concretions when they were re-examined 1 year after the procedure. In our series seven patients with choledocholithiasis still had their gallbladder and two had stones in the organ. At the time of follow-up assessment one had passed his stones; the other . did not undergo repeat ERCP but was asymptomatic, so it was concluded that the stones had passed spontaneously. Endoscopic sphincterotomy eliminates the hazards of anesthesia, laparotomy and duodenotomy, but complications of sphincterotomy do FIG 4 Large black stone in duo occur. The hospital stay is also redenum after removal from common duced, from an average of 2 weeks bile duct with dormia type basket after transduodenal sphincterotomy
Re tpVMt*
21
5
to 2 days after endoscopic sphincterotomy. Although endoscopic sphincterotomy has been reserved for the elderly and patients at high surgical risk, its low mortality and morbidity compared with the rates for transduodenal sphincterotomy will make it the preferred procedure for the treatment of choledocholithiasis and papillary stenosis in younger patients who have had a cholecystectomy. References 1. KAwAI K, AKASAKA Y, MURAKAMI K,
et al: Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 20: 148, 1974 2. KocH H, R6SCH W, ScHAFFNER 0, et al: Endoscopic papillotomy. Gastroenterology 73: 1393, 1977 3. CLASSEN M, SAFRANY L: Endoscopic papillotomy and removal of gallstones. Br Med J 4: 371, 1975 4. CLASSEN M, DEMLING L: Endosko-
pische Sphinkterotomie der Papilla Vateri und Steinextraktion aus dem Ductus choledochus. Dtsch Med Wochenschr 99: 469, 1974 5. KAwAT K, NAKAJIMA M, KIMOTO K, et al: Endoscopic sphincterotomy of the ampulla of Vater. Endoscopy 7:
30, 1975
. .
.
6. COTrON PB: ERCP. Gut 18: 316, 1977
7. SAFRANY L: Duodenoscopic sphincterotomy and gallstone removal. Gas-
troenterology 72: 338, 1977 8. GEENEN JE, HOGAN WJ, SHAFFER RD, et al: Endoscopic electrosurgical papillotomy and manometry in biliary tract disease. JAMA 237: 2075, 1977 9. GEENEN JE, STEWART ET, SHAFFER RD, et al: Endoscopic papillotomy (EP): preliminary clinical experience with nonoperative transendoscopic electrosurgery of the papilla of Vater in biliary tract disease (abstr). Gastro-
intest Endosc 22: 225, 1976 10. ZIMMON DS, FALKENSTEIN DB, KESSLER RE: Endoscopic papillotomy for choledocholithiasis. N Engi J Med
FIG 5A-Stone in common bile duct 1206
FIG 5B-One week later, stone is not detectable becanse it has passed spon taneously
CMA JOURNAL/NOVEMBER 18, 1978/VOL. 119
293: 1181, 1975 11. BOHMIG HJ, FRITSCH A, Kux M, et al: Indikationen und Ergebnisse der transduodenalen Sphincterotomie. Langenbecks Arch Kim Chir 323: 173, 1969
The first electrosurgical endoscopic sphincterotomies of the ampulla of Vater for the removal of common bile duct stones were performed about 4 years ago in Japan and 14 In preliminary studies Kawai and associates1 had performed the operation in dogs. Since the introduction of this technique it has proved to be a safe, effective procedure in elderly, frail patients who are unfit for conventional surgical procedures. Even in younger patients the short-term morbidity and mortality, compared with the rates for conventional procedures, are appreciably less, and the technique is gaining wider acceptance. In this paper we describe the technique and report our first 26 cases in which it was attempted; in 21 instances it was successful. Patients and methods
All patients referred to the gastrointestinal service of Henderson General Hospital, Hamilton, with a diagnosis of choledocholithiasis or papillary stenosis with associated biochemical evidence of cholestasis were considered for endoscopic sphincterotomy. Patients without a previous cholecystectomy were referred for conventional surgical intervention unless they were considered to be at high surgical risk. Informed consent was obtained for endoscopic sphincterotomy from the 27 patients or their relatives. A comFrom the departments of medicine and radiology, Henderson General Hospital, Hamilton Reprint requests to: Dr. Mario F. Castelli, Medical Arts Building, 1 Young St., Hamilton, Ont. L8N 1T8
plete blood count and a platelet count were done and the prothrombin and partial thromboplastin times were determined in all patients. When coagulation abnormalities were found they were corrected before the procedure was undertaken. Patients with acute pancreatitis had the procedure deferred until 2 weeks after resolution of the acute pancreatitis. Patients with acute ascending cholangitis were referred for emergency sphincterotomy. Most of the patients were elderly; the average age was 74 years (range 39 to 95 years). Nineteen of the patients were women. All 27 complained of abdominal pain, 23 had a history of jaundice and 14 had jaundice at the time of referral. Nineteen patients had had a cholecystectomy previously. The serum alkaline phosphatase value was elevated in 23 and the serum amylase value was elevated in 5. With an Olympus JF-B2 fibreoptic
ally performed 1 week after the
sphincterotomy. Results Table I tabulates our results. En-
doscopic sphincterotomy was successful in 21 (81 %) of the 26 patients in whom it was attempted. The 21 patients were subsequently free of pain, jaundice and ascending cholangitis. There were no deaths that could be directly related to the procedure. Choledocholithiasis Of 22 patients who were referred because of choledocholithiasis 17 were free of stones in the common bile duct at the time of follow-up ERCP. Two patients refused followup ERCP, but their stones may have passed spontaneously since they were asymptomatic at the time of followup assessment. The rate of success for endoscopic sphincterotomy in this group was 86%. The procedure was successful side-viewing duodenoscope, endo- in all but two of the patients in whom scopic retrograde cholangiopancrea- ERCP was successful; one patient, tography (ERCP) was performed in who was asymptomatic at the time the standard fashion. A sphinctero- of follow-up assessment, had a stone tome developed by Classen and Dem- in the common bile duct that proved ling4 and modified by Safrany7 (Fig. too large to remove by any means, 1) was introduced into the common including surgical choledochoduodebile duct (Fig. 2); the sphincterotome nostomy (endoscopic sphincterotomy wire was then bowed open and a was attempted but was inadequate). blended coagulating-cutting current The procedure also failed in an used to unroof the papilla (Fig. 3). 85-year-old woman who presented We used a Cammeron-Miller coagu- with ascending cholangitis. She unlator unit (model 80-7960, Cam- derwent cholecystostomy but retained meron-Miller Surgical Instruments stones in the common bile duct. BeCompany, Chicago). The common cause of a large duodenal diverticubile duct stones were then extracted lum endoscopic sphincterotomy was with a dormia-type basket (Figs. 1 unsuccessful. The patient had recurand 4) or left to pass spontaneously rent attacks of ascending cholangitis (Fig. 5). Follow-up ERCP was usu- and died 3 weeks later.
1204 CMA JOURNAL/NOVEMBER 18, 1978/VOL. 119
In one 80-year-old woman who presented with ascending cholangitis endoscopic sphincterotomy was not attempted because ERCP was unsuccessful. Papillary stenosis Five patients were referred for endoscopic sphincterotomy because of papillary stenosis; ERCP was successful in all five when the catheter was jammed into the papillary orifice. In two patients the procedure was successful and they are now free of pain, jaundice and ascending cholangitis; follow-up ERCP demonstrated
JK. A ,...-J.e4.
II
I
a decrease in the size of the common bile duct. In three patients the procedure was attempted early in our experience and failed; the three did not have biochemical evidence of cholestasis, and so would not meet our current criteria for undergoing endoscopic sphincterotomy. If evidence of cholestasis develops, the procedure will be attempted again or they will be referred for a conventional operation. Complications Bleeding and ascending cholangitis: A 71-year-old man presented
- -. -.
Discussion
FIG. 1-Left: open sphincterotome. Centre and right: baskets for removing stones from common bile duct.
FIG. 2-Sphincterotome being introduced into common bile duct through ampulla of Vater.
with ascending cholangitis. He had previously had a cholecystectomy, and 7 years before presentation had undergone surgical sphincteroplasty. ERCP and endoscopic sphincterotomy were performed through the sphincteroplasty, which was scarred to such a degree that passage of the sphincterotome was difficult. The sphincterotomy was 1.5 cm in diameter, but moderate bleeding made complete removal of sludge and stones from the common bile duct impossible. The bleeding stopped after the transfusion of 2 units of whole blood. The patient was discharged from hospital, but presented 1 week later with ascending cholangitis. Concretions remaining in the common bile duct were removed surgically; the lower common bile duct was widely patent. At the time this report was written the patient had been asymptomatic for 6 months. Transient paralytic ileus: One patient had a huge stone in the common bile duct that passed spontaneously, but transient paralytic ileus developed 5 days after endoscopic sphincterotomy was performed. This may have been due to transient gallstone ileus since the patient had abdominal pain 4 days after endoscopic sphincterotomy was performed, which suggests passage of the stone from the common bile duct.
FIG. 3-Unroofed papilla after sphincterotomy.
The procedure we have described was pioneered in Japan and Germany'. and has been introduced in the United States.7-10 It has proven to be a very safe, effective and economical alternative to conventional surgical treatment of choledocholithiasis, ampullary stenosis and ampullary carcinoma. In compiled series good results have been reported in up to 96% of cases.2 Our experience with the treatment of choledocholithiasis is comparable, the success rate for the procedure being 86%, but we had more difficulty with papillary stenosis and were successful in treating only two of the five patients with this condition. With increasing experience our rate of success in treating papillary stenosis by means of endoscopic sphincterotomy will likely improve. Bleeding from the sphincterotomy site, acute pancreatitis, cholangitis, duodenal perforation and instrument
CMA JOURNAL/NOVEMBER 18, 1978/VOL. 119 1205
injury (e.g., trapping of the dormia basket in the common bile duct) have been reported as complications of endoscopic sphincterotomy.2'7 The mortality was 1.2% and 0.8% in the series by Safrany7 and Koch and colleagues2 respectively, as compared with an average surgical mortality of 4.2% for transduodenal 4rttaI sphincterotomy." In our series the 11 mwpeth3.#U. only complication related to the procedure was mild bleeding necessitating the transfusion of 2 units of endoscopic sphincterotomy. blood; in this patient ascending choland colleagues2 re-examined angitis occurred 1 week after the pro- 170Koch patients after endoscopic cedure. In another patient transient sphincterotomy1 year was and gallstone ileus occurred 5 days after found restenosis in 2 performed patients. They suggested that cholecystectomy might not be necessary after endoscopic sphincterotomy in patients at high risk. Four of their patients were found to have passed gallstones and concretions when they were re-examined 1 year after the procedure. In our series seven patients with choledocholithiasis still had their gallbladder and two had stones in the organ. At the time of follow-up assessment one had passed his stones; the other . did not undergo repeat ERCP but was asymptomatic, so it was concluded that the stones had passed spontaneously. Endoscopic sphincterotomy eliminates the hazards of anesthesia, laparotomy and duodenotomy, but complications of sphincterotomy do FIG 4 Large black stone in duo occur. The hospital stay is also redenum after removal from common duced, from an average of 2 weeks bile duct with dormia type basket after transduodenal sphincterotomy
Re tpVMt*
21
5
to 2 days after endoscopic sphincterotomy. Although endoscopic sphincterotomy has been reserved for the elderly and patients at high surgical risk, its low mortality and morbidity compared with the rates for transduodenal sphincterotomy will make it the preferred procedure for the treatment of choledocholithiasis and papillary stenosis in younger patients who have had a cholecystectomy. References 1. KAwAI K, AKASAKA Y, MURAKAMI K,
et al: Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 20: 148, 1974 2. KocH H, R6SCH W, ScHAFFNER 0, et al: Endoscopic papillotomy. Gastroenterology 73: 1393, 1977 3. CLASSEN M, SAFRANY L: Endoscopic papillotomy and removal of gallstones. Br Med J 4: 371, 1975 4. CLASSEN M, DEMLING L: Endosko-
pische Sphinkterotomie der Papilla Vateri und Steinextraktion aus dem Ductus choledochus. Dtsch Med Wochenschr 99: 469, 1974 5. KAwAT K, NAKAJIMA M, KIMOTO K, et al: Endoscopic sphincterotomy of the ampulla of Vater. Endoscopy 7:
30, 1975
. .
.
6. COTrON PB: ERCP. Gut 18: 316, 1977
7. SAFRANY L: Duodenoscopic sphincterotomy and gallstone removal. Gas-
troenterology 72: 338, 1977 8. GEENEN JE, HOGAN WJ, SHAFFER RD, et al: Endoscopic electrosurgical papillotomy and manometry in biliary tract disease. JAMA 237: 2075, 1977 9. GEENEN JE, STEWART ET, SHAFFER RD, et al: Endoscopic papillotomy (EP): preliminary clinical experience with nonoperative transendoscopic electrosurgery of the papilla of Vater in biliary tract disease (abstr). Gastro-
intest Endosc 22: 225, 1976 10. ZIMMON DS, FALKENSTEIN DB, KESSLER RE: Endoscopic papillotomy for choledocholithiasis. N Engi J Med
FIG 5A-Stone in common bile duct 1206
FIG 5B-One week later, stone is not detectable becanse it has passed spon taneously
CMA JOURNAL/NOVEMBER 18, 1978/VOL. 119
293: 1181, 1975 11. BOHMIG HJ, FRITSCH A, Kux M, et al: Indikationen und Ergebnisse der transduodenalen Sphincterotomie. Langenbecks Arch Kim Chir 323: 173, 1969
