Br. J. Surg. 1992, Vol. 79, December, 1346-1 347
M . S. Wilson, D. E. F. Tweedle and D. F. Martin* Departments of Surgery and *Radiology, Gastroenterology Unit, Withington Hospital, University Hospital of South Manchester, Manchester, UK Correspondence to: Mr M. S. Wilson, Department of
Clinical Research, Christie Hospital Trust, Wilmslow Road, Manchester M20 9BX, UK
Common bile duct diameter and complications of endoscopic sphincterotomy To assess the relationship between distal common bile duct ( C B D ) diameter and the incidence of an immediate complication following endoscopic sphincterotomy ( E S ) , all patients undergoing ES between Januar-v 1986 and October 1990 were studied. The overall risk of an immediate complication following ES in 655 patients was 5.6 per cent (37 patients). Patients with calculi were at greater risk i f the distal CBD was dilated ( P < 0.001); the complication in those with stones was most likely to be haemorrhage (81 per cent). The relative risk of a complication increased ten times if the distal bile duct diameter was >0-8 cm. Patients with stricture of the distal CBD did not have a significantly greater risk of complication than those with stones (9.7 versus 4.9 per cent). There was no signiJicant difference between the mean distal CBD diameter of those with stricture and controls (0.61 versus 0.44 cm).
Endoscopic sphincterotomy (ES ) is often required to remove common bile duct ( C B D ) stones and to treat bile duct obstruction due to neoplasm and stricture. In experienced hands, ES has a 30-day mortality rate of 0.5-1.5 per cent and morbidity rate of 2.5-11.3 per cent’.*. The complication rate decreases with greater and increases with patient age4*5.ES may be more hazardous in those with a relatively small papilla and a CBD that is either non-dilated or tapers distally6. In patients with dysfunction of the sphincter of Oddi, the risk of complication is greater in individuals with a small-diameter CBD7. In this study, the relationship between duct diameter and the incidence of haemorrhage and retroperitoneal perforation (complications directly related to ES) was examined.
Patients and methods Between January 1986 and October 1990 a total of 655 patients, of median age 71 (range 22-95) years underwent ES. Of these, 552 (84 per cent) had ES for choledocholithiasis and 103 for malignant (96) or benign (seven) stricture. The length of sphincterotomy was tailored to the size of the stone or to achieve access to the bile duct. Although difficult to measure, the length of incision performed can be related to anatomical landmarks. For small stones ( 1 0 . 5 cm in size) in normal-calibre ducts, sphincterotomy was extended to the upper limit of the visible intramural segment of the CBD. For stones between 0.5 and 1.5 cm in diameter, ES was extended on to the plane above the papilla, but short of the transverse fold. For stones > 1.5 cm, sphincterotomy was extended towards the transverse fold. The diameters of the common hepatic duct and distal CBD were measured on the films, the latter at a constant point immediately above the choledochal sphincter (Figure J ). The diameter of the most distal calculus was measured in 25 of 27 patients who had stones and a complication. Magnification was determined from the diameter of the endoscope. It was impossible to measure stone size in two patients because of the position of the endoscope on the films. Measurements were made in patients with complications and in paired patients without complication. They were matched by pathology and then by age, 86 per cent of the pairs being age-matched to within 4 years. Control patients had a median age of 72 (range 30-89) years and patients with complications a median age of 71 (range 34-93) years. Haemorrhage was defined as a fall in haemoglobin concentration of 2 2 g,’dl. Retroperitoneal perforation was diagnosed by detection of free gas on films taken routinely after the procedures. Presented t o the British Societ-v of Gastroenterology in Shefield, U K , March 1992 and published in abstract form as Gut 1992; 33: S27
Figure 1 he pa to hi liar^^ system with arrows showing the point of meusurrmeni of the distal common bile ducf immediately above the c~holedochulsphincter
Results Thirty-seven patients (5.6 per cent) had a complication during the procedure directly related to ES. Twenty-seven had duct stones, two had benign strictures and eight malignant obstruction of the distal bile duct. The complication rate in patients with stones was 4.9 per cent; it was 9.7 per cent in those with stricture. This difference was not statistically significant (Yates’ x’ = 2.9, 1 d.f., P = 0.09). There was no death directly related to ES. Haemorrhage occurred in 28 patients (Table 1) and was the most common complication (81 per cent in patients with stones, 60 per cent in those with stricture, 76 per cent overall). Four patients needed transfusion and two required laparotomy to control haemorrhage. Retroperitoneal perforation occurred in nine patients (24 per cent); it was often clinically silent’. The diameter of the distal CBD in patients with complications had a geometric mean of 0.92 (range 0.3-2.8) cm. In the control group, the geometric mean was 0.56 (range 0.2-1.2) cm. This difference was highly significant (paired t = 5.2, 36 d.f., P < 0,001 ). Patients with haemorrhage had significantly wider ducts than the control group (paired t = 5.2,28 d.f., P < 0,001); those with perforation had a CBD diameter equal to the controls ( t = 1.8, 7 d.f., P = 0.11). Patients with stones and a complication ( T u b l e 2 ) had significantly wider distal ducts than the control group (paired t = 6.3, 26 d.f., P < 0,001) and patients with stricture and a
~
1346
__
-~
- -
0007-1323192 121 146-02
1
1992 Butterworth-Heinernam Ltd
Complications of endoscopic sphincterotomy: M. S. Wilson et al. Table 1
Complications of endoscopic sphincterotomy
Haemorrhage Stones Malignant stricture Benign stricture
22 5 1
Total
28
Table 2
Retroperitoneal perforation
Distal common bile duct diameter after correction for
mayn$cation
Group
No.
Geometric mean (95% confidence interval) (cm)
Controls Patients with stones
21 27
0.61 (0.55-0.66) 1.04 (0.90-1.21)
Controls Patients with stricture
10
0.44 (0.28-0.66) 0.61 (0.42-0.87)
*Student's paired
t
10
P*
1 1
0.8 cm than in those with a duct G0.8 cm. The type of complication was not significantly associated with the type of obstruction ( P = 0.17, Fisher's exact test). The mean common hepatic duct diameter (0.13 (95 per cent confidence interval -0.23 to 0.49) cm) did not differ between those with complications and controls (paired t = 0.7, 36 d.f., P = 0.47).
Discussion Risk factors related to complications after ES include: experience of the e n d o ~ c o p i s t ~ -enlarging ~; a pre-existing s p h i n c t e r ~ t o m y ~age ; of the ~ a t i e n t ~serum . ~ ; bilirubin and albumin levels'; and coagulation factors". This study evaluated the relationship between bile duct diameter and the risk of developing an immediate complication of ES. Sphincterotomy may be more hazardous in patients with a duct that is not dilated or tapered distally6, particularly if performed for dysfunction of the sphincter of Oddi7. The overall complication rate was 5.6 per cent. Patients with stricture of the distal biliary tree did not have a significantly higher complication rate than those with stones (9.7 uersus 4.9 per cent ). Haemorrhage and retroperitoneal perforation were assessed as these were directly related to ES. Pancreatitis is not a direct complication of ES, but occurs because of manipulation of the papilla during the attempt to gain access to the CBD. It occurs if there have been repeated cannulations of the pancreatic duct. Cholangitis may follow ES, but usually occurs because of failure to achieve adequate biliary drainage. By following an active policy of clearing stones from the ducts immediately after ES, this risk of cholangitis is negated' I . In patients with haemorrhage, the diameter of the distal CBD was significantly greater than in controls. Haemorrhage was the most common complication (81 per cent in patients with stones, 60 per cent in those with stricture, 76 per cent overall ).
Br. J. Surg., Vol. 79, No. 12, December 1992
In about 4 per cent of patients, the gastroduodenal artery or a major branch of this vessel lies in the region of the sphincterotomy incision, and the length of the latter may therefore correlate with the risk of haemorrhage3. This study suggests that the degree of duct dilation is related to the size of the most distal stone. When the duct is dilated by a stone larger than the normal CBD diameter, the sphincterotomy required will be longer than in a normal-calibre duct, making vessels more vulnerable to damage. Previous studies indicate that depth of jaundice, results of clotting studies and liver function are not associated with a major risk of haemorrhage2~4-8,'0. Other factors may influence mortality following a complication but d o not affect the initial risk of developing the complication. Perforation of the duodenum and bile duct usually occurs at the choledochoduodenal junction. In this study, distal duct diameter in patients who developed a perforation did not differ from that of paired controls. Contrary to previous data6, this study shows that patients who have dilated distal ducts due to stones are more likely to have a complication than those with a normal-calibre duct and calculi. The risk of a complication of ES is greater in narrow-calibre ducts in patients with dysfunction of the sphincter of Oddi'. The most common complication in this study was haemorrhage and this was related to the size of the calculus and the length of ES required. Haemorrhage was more likely to occur if the distal duct was dilated, irrespective of cause; CBD dilation may cause the local vessels to be more vulnerable. There was a tenfold increased risk of complication if the distal duct was >0.8 cm in diameter. It may be prudent to reduce the size of the obstructing calculus by mechanical lithotripsy to reduce the length of ES required while allowing successful duct clearance.
Acknowledgements The authors thank Julie Morris and Derrick Bennett,.Department of Medical Statistics, University Hospital of South Manchester, for assistance with the statistical analysis.
References 1.
2. 3. 4.
5. 6. 7.
8. 9. 10. 11.
Connors PJ, Carr-Locke DL. Biliary endoscopy. Curr Opin Gastrorntrrol 1990; 6 : 697-707. Lambert M E , Betts CD, Hill J, Farragher EB, Martin D F , Tweedle DEF. Endoscopic sphincterotomy : the whole truth Br J Surg 1991; 78: 473-6. Classen M . Endoscopic papillotomy. In: Sivak M, ed. Gastroenterologic Endoscopy. Philadelphia: WB Saunders, 1987: 631-51. McGregor J, Martin D F , Lambert ME, Tweedle DEF. Risk factors in endoscopic sphincterotomy. N Enyl Gastroenterol Soc 1987; (Abstract). Mee AS, Vallon AG, Croker JR, Cotton PB. Non-operative removal of bile duct stones by duodenoscopic sphincterotomy in the elderly. B M J 1981; 283: 521-3. Cotton PB, Williams CB. Pructicul Gusrroj~iresti~inl Enilo.c.c~npy. 3rd ed. Oxford: Blackwell Scientific. 1990: 118-29. Sherman S, RufTolo TA, Hawes RH, Lehman GA. Complications of endoscopic sphincterotomy. Go.c.tr.oc~nr~rolo~~~~ 1991: 101: 1068-75. Martin DF, Tweedle DEF. Retroperitoneal perforation during ERCP and endoscopic sphincterotomy: causes, clinical features and management. Endoscopy 1990; 22: 174-5. Neoptolemos JP, Shaw DE, Carr-Locke DL. A multivariate analysis of preoperative risk factors in patients with common bile duct stones. Ant7 Sury 1989; 209: 157-61. Maxwell AJ, Hill J, Tweedle DEF, Martin DF. Do measured parameters of blood clotting help predict haemorrhage after endoscopic sphincterotomy? Gut 1990: 31. A608. Martin DF, McGregor JC, Lambert ME, Tweedle DEF. Stone extraction after ES - an active policy is best. Gut 1987; 28: A1 360- 1.
Paper accepted 5 June 1992
1347
M . S. Wilson, D. E. F. Tweedle and D. F. Martin* Departments of Surgery and *Radiology, Gastroenterology Unit, Withington Hospital, University Hospital of South Manchester, Manchester, UK Correspondence to: Mr M. S. Wilson, Department of
Clinical Research, Christie Hospital Trust, Wilmslow Road, Manchester M20 9BX, UK
Common bile duct diameter and complications of endoscopic sphincterotomy To assess the relationship between distal common bile duct ( C B D ) diameter and the incidence of an immediate complication following endoscopic sphincterotomy ( E S ) , all patients undergoing ES between Januar-v 1986 and October 1990 were studied. The overall risk of an immediate complication following ES in 655 patients was 5.6 per cent (37 patients). Patients with calculi were at greater risk i f the distal CBD was dilated ( P < 0.001); the complication in those with stones was most likely to be haemorrhage (81 per cent). The relative risk of a complication increased ten times if the distal bile duct diameter was >0-8 cm. Patients with stricture of the distal CBD did not have a significantly greater risk of complication than those with stones (9.7 versus 4.9 per cent). There was no signiJicant difference between the mean distal CBD diameter of those with stricture and controls (0.61 versus 0.44 cm).
Endoscopic sphincterotomy (ES ) is often required to remove common bile duct ( C B D ) stones and to treat bile duct obstruction due to neoplasm and stricture. In experienced hands, ES has a 30-day mortality rate of 0.5-1.5 per cent and morbidity rate of 2.5-11.3 per cent’.*. The complication rate decreases with greater and increases with patient age4*5.ES may be more hazardous in those with a relatively small papilla and a CBD that is either non-dilated or tapers distally6. In patients with dysfunction of the sphincter of Oddi, the risk of complication is greater in individuals with a small-diameter CBD7. In this study, the relationship between duct diameter and the incidence of haemorrhage and retroperitoneal perforation (complications directly related to ES) was examined.
Patients and methods Between January 1986 and October 1990 a total of 655 patients, of median age 71 (range 22-95) years underwent ES. Of these, 552 (84 per cent) had ES for choledocholithiasis and 103 for malignant (96) or benign (seven) stricture. The length of sphincterotomy was tailored to the size of the stone or to achieve access to the bile duct. Although difficult to measure, the length of incision performed can be related to anatomical landmarks. For small stones ( 1 0 . 5 cm in size) in normal-calibre ducts, sphincterotomy was extended to the upper limit of the visible intramural segment of the CBD. For stones between 0.5 and 1.5 cm in diameter, ES was extended on to the plane above the papilla, but short of the transverse fold. For stones > 1.5 cm, sphincterotomy was extended towards the transverse fold. The diameters of the common hepatic duct and distal CBD were measured on the films, the latter at a constant point immediately above the choledochal sphincter (Figure J ). The diameter of the most distal calculus was measured in 25 of 27 patients who had stones and a complication. Magnification was determined from the diameter of the endoscope. It was impossible to measure stone size in two patients because of the position of the endoscope on the films. Measurements were made in patients with complications and in paired patients without complication. They were matched by pathology and then by age, 86 per cent of the pairs being age-matched to within 4 years. Control patients had a median age of 72 (range 30-89) years and patients with complications a median age of 71 (range 34-93) years. Haemorrhage was defined as a fall in haemoglobin concentration of 2 2 g,’dl. Retroperitoneal perforation was diagnosed by detection of free gas on films taken routinely after the procedures. Presented t o the British Societ-v of Gastroenterology in Shefield, U K , March 1992 and published in abstract form as Gut 1992; 33: S27
Figure 1 he pa to hi liar^^ system with arrows showing the point of meusurrmeni of the distal common bile ducf immediately above the c~holedochulsphincter
Results Thirty-seven patients (5.6 per cent) had a complication during the procedure directly related to ES. Twenty-seven had duct stones, two had benign strictures and eight malignant obstruction of the distal bile duct. The complication rate in patients with stones was 4.9 per cent; it was 9.7 per cent in those with stricture. This difference was not statistically significant (Yates’ x’ = 2.9, 1 d.f., P = 0.09). There was no death directly related to ES. Haemorrhage occurred in 28 patients (Table 1) and was the most common complication (81 per cent in patients with stones, 60 per cent in those with stricture, 76 per cent overall). Four patients needed transfusion and two required laparotomy to control haemorrhage. Retroperitoneal perforation occurred in nine patients (24 per cent); it was often clinically silent’. The diameter of the distal CBD in patients with complications had a geometric mean of 0.92 (range 0.3-2.8) cm. In the control group, the geometric mean was 0.56 (range 0.2-1.2) cm. This difference was highly significant (paired t = 5.2, 36 d.f., P < 0,001 ). Patients with haemorrhage had significantly wider ducts than the control group (paired t = 5.2,28 d.f., P < 0,001); those with perforation had a CBD diameter equal to the controls ( t = 1.8, 7 d.f., P = 0.11). Patients with stones and a complication ( T u b l e 2 ) had significantly wider distal ducts than the control group (paired t = 6.3, 26 d.f., P < 0,001) and patients with stricture and a
~
1346
__
-~
- -
0007-1323192 121 146-02
1
1992 Butterworth-Heinernam Ltd
Complications of endoscopic sphincterotomy: M. S. Wilson et al. Table 1
Complications of endoscopic sphincterotomy
Haemorrhage Stones Malignant stricture Benign stricture
22 5 1
Total
28
Table 2
Retroperitoneal perforation
Distal common bile duct diameter after correction for
mayn$cation
Group
No.
Geometric mean (95% confidence interval) (cm)
Controls Patients with stones
21 27
0.61 (0.55-0.66) 1.04 (0.90-1.21)
Controls Patients with stricture
10
0.44 (0.28-0.66) 0.61 (0.42-0.87)
*Student's paired
t
10
P*
1 1
0.8 cm than in those with a duct G0.8 cm. The type of complication was not significantly associated with the type of obstruction ( P = 0.17, Fisher's exact test). The mean common hepatic duct diameter (0.13 (95 per cent confidence interval -0.23 to 0.49) cm) did not differ between those with complications and controls (paired t = 0.7, 36 d.f., P = 0.47).
Discussion Risk factors related to complications after ES include: experience of the e n d o ~ c o p i s t ~ -enlarging ~; a pre-existing s p h i n c t e r ~ t o m y ~age ; of the ~ a t i e n t ~serum . ~ ; bilirubin and albumin levels'; and coagulation factors". This study evaluated the relationship between bile duct diameter and the risk of developing an immediate complication of ES. Sphincterotomy may be more hazardous in patients with a duct that is not dilated or tapered distally6, particularly if performed for dysfunction of the sphincter of Oddi7. The overall complication rate was 5.6 per cent. Patients with stricture of the distal biliary tree did not have a significantly higher complication rate than those with stones (9.7 uersus 4.9 per cent ). Haemorrhage and retroperitoneal perforation were assessed as these were directly related to ES. Pancreatitis is not a direct complication of ES, but occurs because of manipulation of the papilla during the attempt to gain access to the CBD. It occurs if there have been repeated cannulations of the pancreatic duct. Cholangitis may follow ES, but usually occurs because of failure to achieve adequate biliary drainage. By following an active policy of clearing stones from the ducts immediately after ES, this risk of cholangitis is negated' I . In patients with haemorrhage, the diameter of the distal CBD was significantly greater than in controls. Haemorrhage was the most common complication (81 per cent in patients with stones, 60 per cent in those with stricture, 76 per cent overall ).
Br. J. Surg., Vol. 79, No. 12, December 1992
In about 4 per cent of patients, the gastroduodenal artery or a major branch of this vessel lies in the region of the sphincterotomy incision, and the length of the latter may therefore correlate with the risk of haemorrhage3. This study suggests that the degree of duct dilation is related to the size of the most distal stone. When the duct is dilated by a stone larger than the normal CBD diameter, the sphincterotomy required will be longer than in a normal-calibre duct, making vessels more vulnerable to damage. Previous studies indicate that depth of jaundice, results of clotting studies and liver function are not associated with a major risk of haemorrhage2~4-8,'0. Other factors may influence mortality following a complication but d o not affect the initial risk of developing the complication. Perforation of the duodenum and bile duct usually occurs at the choledochoduodenal junction. In this study, distal duct diameter in patients who developed a perforation did not differ from that of paired controls. Contrary to previous data6, this study shows that patients who have dilated distal ducts due to stones are more likely to have a complication than those with a normal-calibre duct and calculi. The risk of a complication of ES is greater in narrow-calibre ducts in patients with dysfunction of the sphincter of Oddi'. The most common complication in this study was haemorrhage and this was related to the size of the calculus and the length of ES required. Haemorrhage was more likely to occur if the distal duct was dilated, irrespective of cause; CBD dilation may cause the local vessels to be more vulnerable. There was a tenfold increased risk of complication if the distal duct was >0.8 cm in diameter. It may be prudent to reduce the size of the obstructing calculus by mechanical lithotripsy to reduce the length of ES required while allowing successful duct clearance.
Acknowledgements The authors thank Julie Morris and Derrick Bennett,.Department of Medical Statistics, University Hospital of South Manchester, for assistance with the statistical analysis.
References 1.
2. 3. 4.
5. 6. 7.
8. 9. 10. 11.
Connors PJ, Carr-Locke DL. Biliary endoscopy. Curr Opin Gastrorntrrol 1990; 6 : 697-707. Lambert M E , Betts CD, Hill J, Farragher EB, Martin D F , Tweedle DEF. Endoscopic sphincterotomy : the whole truth Br J Surg 1991; 78: 473-6. Classen M . Endoscopic papillotomy. In: Sivak M, ed. Gastroenterologic Endoscopy. Philadelphia: WB Saunders, 1987: 631-51. McGregor J, Martin D F , Lambert ME, Tweedle DEF. Risk factors in endoscopic sphincterotomy. N Enyl Gastroenterol Soc 1987; (Abstract). Mee AS, Vallon AG, Croker JR, Cotton PB. Non-operative removal of bile duct stones by duodenoscopic sphincterotomy in the elderly. B M J 1981; 283: 521-3. Cotton PB, Williams CB. Pructicul Gusrroj~iresti~inl Enilo.c.c~npy. 3rd ed. Oxford: Blackwell Scientific. 1990: 118-29. Sherman S, RufTolo TA, Hawes RH, Lehman GA. Complications of endoscopic sphincterotomy. Go.c.tr.oc~nr~rolo~~~~ 1991: 101: 1068-75. Martin DF, Tweedle DEF. Retroperitoneal perforation during ERCP and endoscopic sphincterotomy: causes, clinical features and management. Endoscopy 1990; 22: 174-5. Neoptolemos JP, Shaw DE, Carr-Locke DL. A multivariate analysis of preoperative risk factors in patients with common bile duct stones. Ant7 Sury 1989; 209: 157-61. Maxwell AJ, Hill J, Tweedle DEF, Martin DF. Do measured parameters of blood clotting help predict haemorrhage after endoscopic sphincterotomy? Gut 1990: 31. A608. Martin DF, McGregor JC, Lambert ME, Tweedle DEF. Stone extraction after ES - an active policy is best. Gut 1987; 28: A1 360- 1.
Paper accepted 5 June 1992
1347
