Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124033
Status:
TERMINATED
Last Update Posted:
2006-09-11
First Post:
2005-07-25
Brief Title:
Management of Common Bile Duct CBD Stones at Laparoscopic Cholecystectomy
Sponsor:
South West Sydney Local Health District
Organization:
South West Sydney Local Health District
Study Overview
Official Title:
Management of CBD Stones at Laparoscopic Cholecystectomy A NSW Collaborative Prospective Randomised Trial to Assess the Value of Transcystically Inserted CBD Stents to Facilitate Post-Operative ERCP
Status:
TERMINATED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to assess whether a new technique called facilitated endoscopic retrograde cholangiopancreatography ERCP is or is not superior to conventional ERCP for removing stones found in the bile duct at the time of laparoscopic cholecystectomy ERCP is an endoscopic procedure used to facilitate the radiological examination and subsequent manipulation of the common bile duct eg opening it up which is called sphincterotomy Both facilitated and conventional ERCP are performed as a separate procedure after the initial gallbladder surgery This is a comparative study of these two techniques in a randomised clinical trial
The aim of this randomised clinical trial is to enable surgeons to decide whether placement of a plastic stent at the time of laparoscopic cholecystectomy will improve the success rate and safety of subsequent ERCP and sphincterotomy
The aim of this randomised clinical trial is to enable surgeons to decide whether placement of a plastic stent at the time of laparoscopic cholecystectomy will improve the success rate and safety of subsequent ERCP and sphincterotomy
Detailed Description:
Symptomatic gallstone disease is common In the year July 2001-2002 laparoscopic cholecystectomy was performed on 5235 patients in NSW public hospitals Up to 18 of patients undergoing laparoscopic cholecystectomy for gallstones may have concomitant common bile duct stones choledocholithiasis Twenty-five percent of bile duct stones are completely unsuspected Therefore the optimal management of bile duct stones is a significant issue for all general surgeons who perform this very common operation Yet the management of these patients in the laparoscopic era remains contentious
Prior to the laparoscopic era cholecystectomy patients with bile duct stones were managed surgically during open cholecystectomy OC with direct exploration of their common bile duct choledochotomy However open surgical bile duct exploration waned in popularity and progressively stones were dealt with endoscopically either pre or post cholecystectomy As laparoscopic technology advances simultaneous clearance of the bile duct at the time of laparoscopic cholecystectomy is regaining popularity
Some surgeons elect to remove bile duct stones at the index operation through the cystic duct This approach has a success rate of between 75 and 90 When there is failure to clear the bile duct transcystically some surgeons proceed to a choledochotomy to clear the duct while others close the cystic duct stump leaving the stones in situ to be removed at a later date by endoscopic retrograde cholangiopancreatography ERCP and sphincterotomy The argument in favour of immediate choledochotomy is that the duct may be cleared in one sitting The argument against it is that the morbidity of choledochotomy is considerable The argument for a subsequent ERCP is that the morbidity of choledochotomy is avoided The argument against subsequent ERCP is that there may be difficulty cannulating the common bile duct and that ERCP with sphincterotomy is associated with a significant morbidity particularly pancreatitis
An alternative approach taken by the majority of surgeons in NSW when confronted by common bile duct stones at laparoscopic cholecystectomy is to close the cystic duct stump in all patients without exploring the duct transcystically Stones are left in situ to be removed at a later date endoscopically - by ERCP and sphincterotomy The attendant risks of this approach are mentioned above
Another approach is to facilitate the performance of post-operative ERCP and sphincterotomy by inserting a stent transcystically at the time of laparoscopic cholecystectomy Facilitated ERCP has recently been reported in a prospective consecutive series from Nepean Hospital Failure to access the common bile duct at first attempt was 12 in this series which compares favourably with duct access failure rates - reported in the literature - of 5-12 without the facilitation of a stent The incidence of pancreatitis bleeding and duodenal perforation after facilitated ERCP was 0 0 and 06 respectively Two cases 12 of cholangitis were also reported Comparison to other series suggests that facilitated ERCP offers real advantages over the conventional unfacilitated ERCP for bile duct stone removal which has a reported pancreatitis rate of 2-11 and our own rate of 8 a bleeding rate of 2-4 and a duodenal perforation rate of 1-4 The mortality rates of these ERCP techniques cannot be compared at this preliminary stage because of insufficient numbers in the Nepean series
Prior to the laparoscopic era cholecystectomy patients with bile duct stones were managed surgically during open cholecystectomy OC with direct exploration of their common bile duct choledochotomy However open surgical bile duct exploration waned in popularity and progressively stones were dealt with endoscopically either pre or post cholecystectomy As laparoscopic technology advances simultaneous clearance of the bile duct at the time of laparoscopic cholecystectomy is regaining popularity
Some surgeons elect to remove bile duct stones at the index operation through the cystic duct This approach has a success rate of between 75 and 90 When there is failure to clear the bile duct transcystically some surgeons proceed to a choledochotomy to clear the duct while others close the cystic duct stump leaving the stones in situ to be removed at a later date by endoscopic retrograde cholangiopancreatography ERCP and sphincterotomy The argument in favour of immediate choledochotomy is that the duct may be cleared in one sitting The argument against it is that the morbidity of choledochotomy is considerable The argument for a subsequent ERCP is that the morbidity of choledochotomy is avoided The argument against subsequent ERCP is that there may be difficulty cannulating the common bile duct and that ERCP with sphincterotomy is associated with a significant morbidity particularly pancreatitis
An alternative approach taken by the majority of surgeons in NSW when confronted by common bile duct stones at laparoscopic cholecystectomy is to close the cystic duct stump in all patients without exploring the duct transcystically Stones are left in situ to be removed at a later date endoscopically - by ERCP and sphincterotomy The attendant risks of this approach are mentioned above
Another approach is to facilitate the performance of post-operative ERCP and sphincterotomy by inserting a stent transcystically at the time of laparoscopic cholecystectomy Facilitated ERCP has recently been reported in a prospective consecutive series from Nepean Hospital Failure to access the common bile duct at first attempt was 12 in this series which compares favourably with duct access failure rates - reported in the literature - of 5-12 without the facilitation of a stent The incidence of pancreatitis bleeding and duodenal perforation after facilitated ERCP was 0 0 and 06 respectively Two cases 12 of cholangitis were also reported Comparison to other series suggests that facilitated ERCP offers real advantages over the conventional unfacilitated ERCP for bile duct stone removal which has a reported pancreatitis rate of 2-11 and our own rate of 8 a bleeding rate of 2-4 and a duodenal perforation rate of 1-4 The mortality rates of these ERCP techniques cannot be compared at this preliminary stage because of insufficient numbers in the Nepean series
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None