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Endoscopic Papillotomy
Vol. 73, No. 6 Printed in U.S .A .
73:1393-1396, 1977 Copyright © 1977 by the American Gastroenterological Association
GASTROENTEROLOGY
ENDOSCOPIC PAPILLOTOMY H. KocH, M.D., W. RoscH, M.D., 0. ScHAFFNER, M.D., AND L. DEMLING, M.D.
Obstruction of the common bile duct can now be relieved by endoscopic electrosurgery. This report describes our experience with 267 patients. In 192 of 222 patients with choledocholithiasis all calculi were evacuated by endoscopic papillotomy (EP). The remaining patients had EP because of papillary stenosis. Complications of EP included nine instances of pancreatitis, seven of bleeding, and two perforations. In 2 of 32 patients having EP for papillary stenosis, restenosis has appeared on follow-up. The two fatalities were attributable to purulent cholangitis and acute bleeding. This complication rate is less than that reported for the traditional surgical procedures required to manage these situations. The endoscopic method requires less hospitalization and recuperation. EP and stone extraction are the methods of choice for managing common duct obstruction in high risk patients before cholecystectomy, for retained or reformed stones after cholecystectomy, and for papillary stenosis. Endoscopic retrograde cholangiopancreatography allows accurate preoperative diagnosis of pancreatic and biliary tract disease. We have applied endoscopic technics to the treatment of common bile duct obstruction. Using a specially adapted cannula (fig. 1) the sphincter muscles of the Vaterian segment are divided by electrocautery with a radiofrequency current. The common duct opening into the duodenum is thus enlarged to permit spontaneous passage or endoscopic extraction of common duct stones, or to open a stenosed distal segment of duct. Our experience with 267 attempts at endoscopic papillotomy (EP) in humans is the subject of this report.
Patients and Methods Patients chosen for EP had choledocholithiasis or papillary stenosis established by prior endoscopic retrograde cholangiopancreatography. The indications in the 254 patients with successful EP are outlined in table 1. In 143 patients surgical management of choledocholithiasis was judged to carry a high risk because of advanced age or associated disease. EP was performed whether or not a previous cholecystectomy has been performed. Another 69 patients had either retained or reformed common duct calculi after cholecystectomy. Fortytwo patients had circumscribed papillary stenosis; 10 of this group also had calculi in the common duct and gallbladder. Papillary stenosis is suspected in the presence of symptoms and laboratory findings consistent with common duct obstruction, associated with a dilated duct. A stenotic segment of the distal duct may or may not be visualized. The diagnosis of papillary stenosis is confirmed in our institution by the presence of increased ductal pressure. 1 Before EP all patients were informed that they would be treated with a new method in order to avoid surgical interven-
tion. They were also informed about possible complications and about the possible necessity of immediate surgery. No intervention was made without informed consent. EP is accomplished by use of a high frequency diathermy probe developed by Demling and Classen. 2 • 3 The EP results in an incision of about 1.0 to 2.0 em as seen in the duodenal wall. Two variables cannot presently be precisely controlled: one cannot be certain whether both sphincters4 or only the sphincter of Oddi has been cut, and one cannot be certain that only the intramural portion of the duct has been incised. 5 In the case of patients with small calculi in a wide prepapillary ~ile duct, these can be extracted immediately ,a fter papillotomy. For this purpose a Dormia basket introduced through a Teflon catheter is advanced into the bile duct beyond the concretion (fig. 2). Then the basket is extended and retracted in the open position. Thus the calculi are caught in the basket and extracted from the bile duct together with the basket (fig. 3).
In all patients an endoscopic follow-up is carried out 3 to 7 days later. Cholangiogram at this time will indicate those patients in whom the stones had not been extracted immediately after papillotomy or had not passed spontaneously by this time; stone extraction is then effected. If larger calculi cannot be extracted, the papillotomy can be extended.
Results EP succeeded in 254 patients of 267 attempted. In 13 patients the papillotomy probe could not be passed into the duct. Spontaneous passing of the stones was observed in 108 cases (table 2); active stone extraction was required in 84 cases. In 12 further cases large stones had to be removed by surgery as we were unable to retrieve them with a basket. Calculi in 18 patients are not yet extracted. It was found that spontaneous passage of calculi always occurred when the width of the bile duct lumen was the same over its whole length until reaching the papilla (type Ia and lb). In all other instances, in which the bile duct lumen tapered toward the papilla (type II), stone extraction with the Dormia basket was necessary (fig. 4). The largest calculus which passed spontaneously was 1.5 by 1.7 em (fig. 5); the largest
Received November 8, 1975. Accepted July 22, 1977. Address requests for reprints to: Priv.-Doz. Dr. med. H. Koch, Medizinische Universitatsklinik, Kranhenhausstrasse 12, D-8520 Erlangen, Germany. The authors are very grateful to J . A. Vennes of Minneapolis and D . Zimmon of New York who helped to bring this paper in line with the current use of the American language. 1393
1394
stone extracted from the bile duct type I was 2.2 by 3.2 em, and from type II, 1.6 by 2.0 em. A number of acute complications of the procedure were evaluated. Seven episodes of slight and two episodes of severe pancreatitis occurred. All of these patients recovered. Significant bleeding occurred in 7 cases; 5 of these required surgery for control of continued hemorrhage as did 2 cases of duodenal perforation. One of the patients with bleeding, an 82-year-old female, died 3 days after surgery. The other patients with bleeding as well as with perforation recovered. In a further 56-year-old female patient, a 3-cm calculus could not be extracted from a tapering (type II) distal duct because it was impacted in the distal duct. Cholangitis developed and the duct was decompressed surgically. The patient did well initially despite the presence of congestive heart failure and hyperthyroidism, but 1 week later the patient deteriorated rapidly and died. At
n
Vol. 73, No.6
KOCH ET AL.
autopsy old liver abscesses and chronic inflammatory changes were found in the bile ducts. One hundred and seven patients have been reexaminated 1 year after EP; no history or findings of late cholangitis have occurred in these or any of the patients TABLE
1. Indications for endoscopic papillotomy (successful cases)
Choledocholithiasis High surgical risk patients with and without gallbladder in situ After previous cholecystectomy Papillary stenosis Choledocholithiasis, cholecystolithiasis, and papillary stenosis
147 74 36 10
267
Total
1 [11111/fi 11f111111111f111111111f111111111f111111111f11)'j1 llllfllll
15
f 16
17
18
19
2 rj
I
21 '
FIG. 1. Papillotoma (developed by Demling and Classen).
FIG. 2. Dormia baskets.
FIG. 3. Calculus caught in a Dormia basket (patient in prone position).
December 1977 TABLE
ENDOSCOPIC PAPILLOTOMY
2. R esults in patients with choledocholithiasis after
endoscopic papillotomy Calculi passed sponta neously Calculi extracted endoscopically Surgica l removal of large calculi Calculi still remaining in the common bile duct
108
Total
222
Ia FIG .
Ib
84 12 18
II
4. Different shapes of the common bile duct.
FIG. 5. The largest stone which passed spontaneously (patient in prone position).
undergoing EP to our knowledge. Two cases of restenosis were found; papillary stenosis was the indication for EP in both cases. One reason for restenosis was probably incomplete EP early in our experience. In the other a papillary carcinoma had been mistaken for adenomyomatosis on biopsy. Discussion The procedure discussed here is an endoscopic alternative to surgical management of common duct obstruction. &-11 In the compiled experience of 16 authors with over 2000 transduodenal papillotomies, "good" results were reported in 96% of patients. 12 Our experience with
1395
development and application of EP lead us to predict comparable results. Long term follow-up data on large numbers of patients is necessary. It will be available in a few years as about 1500 EP have been performed since 1973 in nine German centers. The morbidity rate in our over-all experience with EP is gratifyingly low. Mortality in repeated surgical procedures on the common duct is substantial, ranging from 4 to 12.3%.13 • 14 In another review of27 authors reporting a total of 5700 transduodenal sphincterotomies, the operative mortality was 4.2%. 12 The incidence of surgical morbidity from common duct perforation, bile fistulae, pancreatitis, and bleeding is also substantial. 14 • 15 While looking toward an ever safer endoscopic procedure, EP now appears to carry less risk than surgery in these difficult, often high risk problems. Furthermore, patients tolerate EP well and recover rapidly. The convalescence required by major abdominal surgery is obviated. Our experience to date suggests that it is not necessary to perform cholecystectomy on older high risk patients after papillotomy when the gallbladder is in situ. Four patients with gallbladder concretions examined 1 year after EP had passed all residual stones. In the remaining cases the:r;~ have been no complications because of the calculi remaining in the gallbladder. Occasionally papillary stenosis coexists with cholelithiasis and choledocholithiasis. EP and stone extraction from the common duct are performed first, followed by cholecystectomy a few weeks later. It is our impression on the basis of limited experience that surgical risk is reduced by this approach. The extraction of large bile duct calculi is a greater problem than endoscopic papillotomy itself. In ·spite of optimal endoscopic papillotomy, stones had to be removed surgically in 12 patients, when the calculi were larger than the width of the papillotomy incision. The shape of the bile duct is important. Where the bile duct lumen tapers toward the papilla, the extraction of large stones was difficult or impossible. If during stone extraction the stone is impacted, surgery should be performed promptly. The functional sequelae of EP may be similar to those of transduodenal papillotomy. Boehmig et al. observed duodenobiliary reflux in 43% of 123 cases after surgical papillotomy, with few complaints. 12 According to previous reports, transduodenal papillotomy does not lead to ascending cholangitis. 6 • 11 • 16 Based on these results and our own experience at 1 year, chronic inflammatory changes of the bile ducts are not to be expected after EP. Conclusion Considering the fact that in the majority of cases EP was a second biliary tract operation or a procedure in a high risk patient, the high success rate and limited morbidity with low mortality suggest that EP is the procedure of choice for managing these patients. Hopefully, further complications will be reduced with increasing experience and the success rate will improve.
1396
KOCH ET AL.
REFERENCES 1. Roesch W, Koch H, Demling L: Manometric studies during ERCP and endoscopic papillotomy. Endoscopy 8:30-33, 1976 2. Boyden EA: The anatomy of the choledochoduodenal junction in man. Surg Gynecol Obstet 104:641, 1957 3. Classen M, Demling L: Endoskopische Sphincterotomie der Papilla Vateri und Steinextraktion aus dem Ductus choledochus. Dtsch Med Wochenschr 99:496-497, 1974 4. Demling L, Koch H, Classen M, et al: Endoskopische Papillotomie und Gallensteinentfernung. Dtsch Med Wochenschr 99: 2255-2257' 1974 5. Kune GA: Surgical anatomy of common bile duct. Arch Surg 89:995-998, 1964 6. Goinard P, Pelissier G: Comte rendu d' une experience de 8 annees de sphincterotomies. Rev lnt Hepatol16:605-609, 1966 7. Kawai K, Akasaka Y, Murakami K, et al: Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 20:148-151, 1974 8. Koch H: Endoscopic papillotomy. Endoscopy 7:89-93, 1975 9. Koch H , Classen M, Schaffner 0, et al: Endoscopic papillotomy-
10. 11.
12.
13. 14.
15. 16.
Vol . 73, No . 6 experimental studies and initial clinical experience. Scand J Gastroenterol10:441-444, 1975 Kuemmerle F: Chirurgische Prinzipien zur Beseitigung von Galleabflusstoerungen. 4. Freiburger Chirurgengespraech 1974 WoltfH, Schenker U, Mlynek HJ: Stellung der transduodenalen Sphincterotomie in der Gallenchirurgie. Zentralbl Chir 99:801806, 1974 Boehmig HJ, Fritsch A, Kux M, et al: lndikationen und Ergebnisse der transduodenalen Sphincterotomie. Langenbecks Arch Klin Chir 323:173-188, 1969 Jones SA, Smith LL: A reappraisal of sphincteroplasty (not sphincterotomy). Surgery 71:565, 1972 Kitfmeyer D: Klinisch-experimentelle Untersuchung zur Pathophysiologie der transduodenalen Sphincterotomie. InauguralDissertation, Bonn, 1973 Jelinek R: Komplikationen und Todesursachen nach der Sphincterotomie. Langenbecks Arch Klin Chir 325:594-598, 1969 Bodner E, Platzer S, Foedisch HJ, et al: Ueber den duodenobiliaeren Reflux nach totaler Sphincterotomie. Zentralbl Chir 99:788-792, 1974
73:1393-1396, 1977 Copyright © 1977 by the American Gastroenterological Association
GASTROENTEROLOGY
ENDOSCOPIC PAPILLOTOMY H. KocH, M.D., W. RoscH, M.D., 0. ScHAFFNER, M.D., AND L. DEMLING, M.D.
Obstruction of the common bile duct can now be relieved by endoscopic electrosurgery. This report describes our experience with 267 patients. In 192 of 222 patients with choledocholithiasis all calculi were evacuated by endoscopic papillotomy (EP). The remaining patients had EP because of papillary stenosis. Complications of EP included nine instances of pancreatitis, seven of bleeding, and two perforations. In 2 of 32 patients having EP for papillary stenosis, restenosis has appeared on follow-up. The two fatalities were attributable to purulent cholangitis and acute bleeding. This complication rate is less than that reported for the traditional surgical procedures required to manage these situations. The endoscopic method requires less hospitalization and recuperation. EP and stone extraction are the methods of choice for managing common duct obstruction in high risk patients before cholecystectomy, for retained or reformed stones after cholecystectomy, and for papillary stenosis. Endoscopic retrograde cholangiopancreatography allows accurate preoperative diagnosis of pancreatic and biliary tract disease. We have applied endoscopic technics to the treatment of common bile duct obstruction. Using a specially adapted cannula (fig. 1) the sphincter muscles of the Vaterian segment are divided by electrocautery with a radiofrequency current. The common duct opening into the duodenum is thus enlarged to permit spontaneous passage or endoscopic extraction of common duct stones, or to open a stenosed distal segment of duct. Our experience with 267 attempts at endoscopic papillotomy (EP) in humans is the subject of this report.
Patients and Methods Patients chosen for EP had choledocholithiasis or papillary stenosis established by prior endoscopic retrograde cholangiopancreatography. The indications in the 254 patients with successful EP are outlined in table 1. In 143 patients surgical management of choledocholithiasis was judged to carry a high risk because of advanced age or associated disease. EP was performed whether or not a previous cholecystectomy has been performed. Another 69 patients had either retained or reformed common duct calculi after cholecystectomy. Fortytwo patients had circumscribed papillary stenosis; 10 of this group also had calculi in the common duct and gallbladder. Papillary stenosis is suspected in the presence of symptoms and laboratory findings consistent with common duct obstruction, associated with a dilated duct. A stenotic segment of the distal duct may or may not be visualized. The diagnosis of papillary stenosis is confirmed in our institution by the presence of increased ductal pressure. 1 Before EP all patients were informed that they would be treated with a new method in order to avoid surgical interven-
tion. They were also informed about possible complications and about the possible necessity of immediate surgery. No intervention was made without informed consent. EP is accomplished by use of a high frequency diathermy probe developed by Demling and Classen. 2 • 3 The EP results in an incision of about 1.0 to 2.0 em as seen in the duodenal wall. Two variables cannot presently be precisely controlled: one cannot be certain whether both sphincters4 or only the sphincter of Oddi has been cut, and one cannot be certain that only the intramural portion of the duct has been incised. 5 In the case of patients with small calculi in a wide prepapillary ~ile duct, these can be extracted immediately ,a fter papillotomy. For this purpose a Dormia basket introduced through a Teflon catheter is advanced into the bile duct beyond the concretion (fig. 2). Then the basket is extended and retracted in the open position. Thus the calculi are caught in the basket and extracted from the bile duct together with the basket (fig. 3).
In all patients an endoscopic follow-up is carried out 3 to 7 days later. Cholangiogram at this time will indicate those patients in whom the stones had not been extracted immediately after papillotomy or had not passed spontaneously by this time; stone extraction is then effected. If larger calculi cannot be extracted, the papillotomy can be extended.
Results EP succeeded in 254 patients of 267 attempted. In 13 patients the papillotomy probe could not be passed into the duct. Spontaneous passing of the stones was observed in 108 cases (table 2); active stone extraction was required in 84 cases. In 12 further cases large stones had to be removed by surgery as we were unable to retrieve them with a basket. Calculi in 18 patients are not yet extracted. It was found that spontaneous passage of calculi always occurred when the width of the bile duct lumen was the same over its whole length until reaching the papilla (type Ia and lb). In all other instances, in which the bile duct lumen tapered toward the papilla (type II), stone extraction with the Dormia basket was necessary (fig. 4). The largest calculus which passed spontaneously was 1.5 by 1.7 em (fig. 5); the largest
Received November 8, 1975. Accepted July 22, 1977. Address requests for reprints to: Priv.-Doz. Dr. med. H. Koch, Medizinische Universitatsklinik, Kranhenhausstrasse 12, D-8520 Erlangen, Germany. The authors are very grateful to J . A. Vennes of Minneapolis and D . Zimmon of New York who helped to bring this paper in line with the current use of the American language. 1393
1394
stone extracted from the bile duct type I was 2.2 by 3.2 em, and from type II, 1.6 by 2.0 em. A number of acute complications of the procedure were evaluated. Seven episodes of slight and two episodes of severe pancreatitis occurred. All of these patients recovered. Significant bleeding occurred in 7 cases; 5 of these required surgery for control of continued hemorrhage as did 2 cases of duodenal perforation. One of the patients with bleeding, an 82-year-old female, died 3 days after surgery. The other patients with bleeding as well as with perforation recovered. In a further 56-year-old female patient, a 3-cm calculus could not be extracted from a tapering (type II) distal duct because it was impacted in the distal duct. Cholangitis developed and the duct was decompressed surgically. The patient did well initially despite the presence of congestive heart failure and hyperthyroidism, but 1 week later the patient deteriorated rapidly and died. At
n
Vol. 73, No.6
KOCH ET AL.
autopsy old liver abscesses and chronic inflammatory changes were found in the bile ducts. One hundred and seven patients have been reexaminated 1 year after EP; no history or findings of late cholangitis have occurred in these or any of the patients TABLE
1. Indications for endoscopic papillotomy (successful cases)
Choledocholithiasis High surgical risk patients with and without gallbladder in situ After previous cholecystectomy Papillary stenosis Choledocholithiasis, cholecystolithiasis, and papillary stenosis
147 74 36 10
267
Total
1 [11111/fi 11f111111111f111111111f111111111f111111111f11)'j1 llllfllll
15
f 16
17
18
19
2 rj
I
21 '
FIG. 1. Papillotoma (developed by Demling and Classen).
FIG. 2. Dormia baskets.
FIG. 3. Calculus caught in a Dormia basket (patient in prone position).
December 1977 TABLE
ENDOSCOPIC PAPILLOTOMY
2. R esults in patients with choledocholithiasis after
endoscopic papillotomy Calculi passed sponta neously Calculi extracted endoscopically Surgica l removal of large calculi Calculi still remaining in the common bile duct
108
Total
222
Ia FIG .
Ib
84 12 18
II
4. Different shapes of the common bile duct.
FIG. 5. The largest stone which passed spontaneously (patient in prone position).
undergoing EP to our knowledge. Two cases of restenosis were found; papillary stenosis was the indication for EP in both cases. One reason for restenosis was probably incomplete EP early in our experience. In the other a papillary carcinoma had been mistaken for adenomyomatosis on biopsy. Discussion The procedure discussed here is an endoscopic alternative to surgical management of common duct obstruction. &-11 In the compiled experience of 16 authors with over 2000 transduodenal papillotomies, "good" results were reported in 96% of patients. 12 Our experience with
1395
development and application of EP lead us to predict comparable results. Long term follow-up data on large numbers of patients is necessary. It will be available in a few years as about 1500 EP have been performed since 1973 in nine German centers. The morbidity rate in our over-all experience with EP is gratifyingly low. Mortality in repeated surgical procedures on the common duct is substantial, ranging from 4 to 12.3%.13 • 14 In another review of27 authors reporting a total of 5700 transduodenal sphincterotomies, the operative mortality was 4.2%. 12 The incidence of surgical morbidity from common duct perforation, bile fistulae, pancreatitis, and bleeding is also substantial. 14 • 15 While looking toward an ever safer endoscopic procedure, EP now appears to carry less risk than surgery in these difficult, often high risk problems. Furthermore, patients tolerate EP well and recover rapidly. The convalescence required by major abdominal surgery is obviated. Our experience to date suggests that it is not necessary to perform cholecystectomy on older high risk patients after papillotomy when the gallbladder is in situ. Four patients with gallbladder concretions examined 1 year after EP had passed all residual stones. In the remaining cases the:r;~ have been no complications because of the calculi remaining in the gallbladder. Occasionally papillary stenosis coexists with cholelithiasis and choledocholithiasis. EP and stone extraction from the common duct are performed first, followed by cholecystectomy a few weeks later. It is our impression on the basis of limited experience that surgical risk is reduced by this approach. The extraction of large bile duct calculi is a greater problem than endoscopic papillotomy itself. In ·spite of optimal endoscopic papillotomy, stones had to be removed surgically in 12 patients, when the calculi were larger than the width of the papillotomy incision. The shape of the bile duct is important. Where the bile duct lumen tapers toward the papilla, the extraction of large stones was difficult or impossible. If during stone extraction the stone is impacted, surgery should be performed promptly. The functional sequelae of EP may be similar to those of transduodenal papillotomy. Boehmig et al. observed duodenobiliary reflux in 43% of 123 cases after surgical papillotomy, with few complaints. 12 According to previous reports, transduodenal papillotomy does not lead to ascending cholangitis. 6 • 11 • 16 Based on these results and our own experience at 1 year, chronic inflammatory changes of the bile ducts are not to be expected after EP. Conclusion Considering the fact that in the majority of cases EP was a second biliary tract operation or a procedure in a high risk patient, the high success rate and limited morbidity with low mortality suggest that EP is the procedure of choice for managing these patients. Hopefully, further complications will be reduced with increasing experience and the success rate will improve.
1396
KOCH ET AL.
REFERENCES 1. Roesch W, Koch H, Demling L: Manometric studies during ERCP and endoscopic papillotomy. Endoscopy 8:30-33, 1976 2. Boyden EA: The anatomy of the choledochoduodenal junction in man. Surg Gynecol Obstet 104:641, 1957 3. Classen M, Demling L: Endoskopische Sphincterotomie der Papilla Vateri und Steinextraktion aus dem Ductus choledochus. Dtsch Med Wochenschr 99:496-497, 1974 4. Demling L, Koch H, Classen M, et al: Endoskopische Papillotomie und Gallensteinentfernung. Dtsch Med Wochenschr 99: 2255-2257' 1974 5. Kune GA: Surgical anatomy of common bile duct. Arch Surg 89:995-998, 1964 6. Goinard P, Pelissier G: Comte rendu d' une experience de 8 annees de sphincterotomies. Rev lnt Hepatol16:605-609, 1966 7. Kawai K, Akasaka Y, Murakami K, et al: Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 20:148-151, 1974 8. Koch H: Endoscopic papillotomy. Endoscopy 7:89-93, 1975 9. Koch H , Classen M, Schaffner 0, et al: Endoscopic papillotomy-
10. 11.
12.
13. 14.
15. 16.
Vol . 73, No . 6 experimental studies and initial clinical experience. Scand J Gastroenterol10:441-444, 1975 Kuemmerle F: Chirurgische Prinzipien zur Beseitigung von Galleabflusstoerungen. 4. Freiburger Chirurgengespraech 1974 WoltfH, Schenker U, Mlynek HJ: Stellung der transduodenalen Sphincterotomie in der Gallenchirurgie. Zentralbl Chir 99:801806, 1974 Boehmig HJ, Fritsch A, Kux M, et al: lndikationen und Ergebnisse der transduodenalen Sphincterotomie. Langenbecks Arch Klin Chir 323:173-188, 1969 Jones SA, Smith LL: A reappraisal of sphincteroplasty (not sphincterotomy). Surgery 71:565, 1972 Kitfmeyer D: Klinisch-experimentelle Untersuchung zur Pathophysiologie der transduodenalen Sphincterotomie. InauguralDissertation, Bonn, 1973 Jelinek R: Komplikationen und Todesursachen nach der Sphincterotomie. Langenbecks Arch Klin Chir 325:594-598, 1969 Bodner E, Platzer S, Foedisch HJ, et al: Ueber den duodenobiliaeren Reflux nach totaler Sphincterotomie. Zentralbl Chir 99:788-792, 1974