search
Back to results

Management of Common Bile Duct (CBD) Stones at Laparoscopic Cholecystectomy

Primary Purpose

Choledocholithiasis, Cholelithiasis

Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Transcystic Stenting (Facilitated ERCP)
Sponsored by
South West Sydney Local Health District
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Choledocholithiasis focused on measuring Cholecystectomy, Cholangiopancreatography, Endoscopic Retrograde

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient must be able to give informed consent preoperatively (i.e. elective procedures only) Patients at higher than normal risk of having CBD stones identified at OC. For example: *CBD stones identified at ultrasound; *Wide CBD (>6mm) at ultrasound; *Previous, recent, current cholangitis, jaundice, or biliary pancreatitis; or *Abnormal AST and ALT levels (>2 times normal). Exclusion Criteria: Pregnancy at time of surgery Patients not fit for surgery. For example: *Those with acute cholecystitis or persistent obstructive jaundice; *Patients who have had a previous ERCP and sphincterotomy; or *Patients in whom intervention was not technically possible (eg. previous Billroth II gastrectomy).

Sites / Locations

  • Bankstown-Lidcombe Hospital
  • Royal Prince Alfred Hospital
  • Dubbo Base Hospital
  • Gosford Hospital
  • Blue Mountains District ANZAC Memorial Hospital
  • Nepean Hospital
  • St George Hospital
  • Liverpool Hospital
  • John Hunter Hospital
  • Prince of Wales Hospital
  • Royal North Shore Hospital
  • Westmead Hospital
  • Hawkesbury District Health Service

Outcomes

Primary Outcome Measures

Safety of facilitated ERCP compared to conventional unfacilitated ERCP - as assessed by the incidence of pancreatitis post ERCP

Secondary Outcome Measures

The success rate and morbidity of transcystic exploration for common bile duct stone removal across a broad spectrum of surgeons
The success rate of transcystic stent placement across a broad spectrum of surgeons
The overall morbidity of post-operative ERCP, with further comparisons of the morbidity of facilitated and conventional ERCP, with and without transcystic exploration of the common bile duct to remove stones
Hospitalisation time according to treatment group
The incidence of hyperamylasemia after transcystic exploration of the common bile duct, transcystic insertion of a stent or transcystic cholangiography alone
The success rate and complications after choledochotomy for common bile duct stones
The failure rate of selective common bile duct cannulation for facilitated ERCP as compared to conventional ERCP
Incidence of multiple endoscopic procedures when the common bile duct was not explored at the primary operation and whether or not this is affected by facilitation at ERCP
Long-term efficacy of techniques used to remove common bile duct stones, as measured by the recurrence of stones in the bile duct

Full Information

First Posted
July 25, 2005
Last Updated
September 7, 2006
Sponsor
South West Sydney Local Health District
Collaborators
Catholic Health Care Services, Greater Western Area Health Service, Hunter New England Area Health Service, Northern Sydney and Central Coast Area Health Service, South Eastern Area Health Service, Sydney South West Area Health Service
search

1. Study Identification

Unique Protocol Identification Number
NCT00124033
Brief Title
Management of Common Bile Duct (CBD) Stones at Laparoscopic Cholecystectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Terminated
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2015 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
South West Sydney Local Health District
Collaborators
Catholic Health Care Services, Greater Western Area Health Service, Hunter New England Area Health Service, Northern Sydney and Central Coast Area Health Service, South Eastern Area Health Service, Sydney South West Area Health Service

4. Oversight

5. Study Description

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.
Detailed Description
Symptomatic gallstone disease is common. In the year July 2001-2002, laparoscopic cholecystectomy was performed on 5,235 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 1.2% 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 0.6%, respectively. Two cases (1.2%) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Cholelithiasis
Keywords
Cholecystectomy, Cholangiopancreatography, Endoscopic Retrograde

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Transcystic Stenting (Facilitated ERCP)
Primary Outcome Measure Information:
Title
Safety of facilitated ERCP compared to conventional unfacilitated ERCP - as assessed by the incidence of pancreatitis post ERCP
Secondary Outcome Measure Information:
Title
The success rate and morbidity of transcystic exploration for common bile duct stone removal across a broad spectrum of surgeons
Title
The success rate of transcystic stent placement across a broad spectrum of surgeons
Title
The overall morbidity of post-operative ERCP, with further comparisons of the morbidity of facilitated and conventional ERCP, with and without transcystic exploration of the common bile duct to remove stones
Title
Hospitalisation time according to treatment group
Title
The incidence of hyperamylasemia after transcystic exploration of the common bile duct, transcystic insertion of a stent or transcystic cholangiography alone
Title
The success rate and complications after choledochotomy for common bile duct stones
Title
The failure rate of selective common bile duct cannulation for facilitated ERCP as compared to conventional ERCP
Title
Incidence of multiple endoscopic procedures when the common bile duct was not explored at the primary operation and whether or not this is affected by facilitation at ERCP
Title
Long-term efficacy of techniques used to remove common bile duct stones, as measured by the recurrence of stones in the bile duct

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must be able to give informed consent preoperatively (i.e. elective procedures only) Patients at higher than normal risk of having CBD stones identified at OC. For example: *CBD stones identified at ultrasound; *Wide CBD (>6mm) at ultrasound; *Previous, recent, current cholangitis, jaundice, or biliary pancreatitis; or *Abnormal AST and ALT levels (>2 times normal). Exclusion Criteria: Pregnancy at time of surgery Patients not fit for surgery. For example: *Those with acute cholecystitis or persistent obstructive jaundice; *Patients who have had a previous ERCP and sphincterotomy; or *Patients in whom intervention was not technically possible (eg. previous Billroth II gastrectomy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Martin, MBBS MSc
Organizational Affiliation
Sydney West Area Health Service (Department of Surgery, Nepean Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Dubbo Base Hospital
City
Dubbo
State/Province
New South Wales
ZIP/Postal Code
2830
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Blue Mountains District ANZAC Memorial Hospital
City
Katoomba
State/Province
New South Wales
ZIP/Postal Code
2780
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Hawkesbury District Health Service
City
Windsor
State/Province
New South Wales
ZIP/Postal Code
2756
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
11982511
Citation
Martin CJ, Cox MR, Vaccaro L. Laparoscopic transcystic bile duct stenting in the management of common bile duct stones. ANZ J Surg. 2002 Apr;72(4):258-64. doi: 10.1046/j.1445-2197.2002.02368.x.
Results Reference
background

Learn more about this trial

Management of Common Bile Duct (CBD) Stones at Laparoscopic Cholecystectomy

We'll reach out to this number within 24 hrs