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

This study has been terminated.
Sponsor:
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
Information provided by:
South West Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT00124033
First received: July 25, 2005
Last updated: September 7, 2006
Last verified: June 2005
  Purpose

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.


Condition Intervention
Choledocholithiasis
Cholelithiasis
Procedure: Transcystic Stenting (Facilitated ERCP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
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

Resource links provided by NLM:


Further study details as provided by South West Sydney Local Health District:

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

Estimated Enrollment: 340
Study Start Date: March 2004
Estimated Study Completion Date: December 2015
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124033

Locations
Australia, New South Wales
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Dubbo Base Hospital
Dubbo, New South Wales, Australia, 2830
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Blue Mountains District ANZAC Memorial Hospital
Katoomba, New South Wales, Australia, 2780
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
St George Hospital
Kogarah, New South Wales, Australia, 2217
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
John Hunter Hospital
New Lambton, New South Wales, Australia, 2300
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Hawkesbury District Health Service
Windsor, New South Wales, Australia, 2756
Sponsors and Collaborators
South West Sydney Local Health District
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
Investigators
Principal Investigator: Christopher J Martin, MBBS MSc Sydney West Area Health Service (Department of Surgery, Nepean Hospital)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00124033     History of Changes
Other Study ID Numbers: 04/001
Study First Received: July 25, 2005
Last Updated: September 7, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by South West Sydney Local Health District:
Cholecystectomy
Cholangiopancreatography, Endoscopic Retrograde

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Choledocholithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases

ClinicalTrials.gov processed this record on August 28, 2014