NCT00124033

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2005

Completed
10.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 11, 2006

Status Verified

June 1, 2005

First QC Date

July 25, 2005

Last Update Submit

September 7, 2006

Conditions

CholedocholithiasisCholelithiasis

Keywords

CholecystectomyCholangiopancreatography, Endoscopic Retrograde

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Interventions

Transcystic Stenting (Facilitated ERCP)PROCEDURE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, 2200, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Dubbo Base Hospital

Dubbo, New South Wales, 2830, Australia

Location

Gosford Hospital

Gosford, New South Wales, 2250, Australia

Location

Blue Mountains District ANZAC Memorial Hospital

Katoomba, New South Wales, 2780, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

John Hunter Hospital

New Lambton, New South Wales, 2300, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Hawkesbury District Health Service

Windsor, New South Wales, 2756, Australia

Location

Related Publications (1)

  • 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.

    PMID: 11982511BACKGROUND

MeSH Terms

Conditions

CholedocholithiasisCholelithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Christopher J Martin, MBBS MSc

    Sydney West Area Health Service (Department of Surgery, Nepean Hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2005

First Posted

July 26, 2005

Study Start

March 1, 2004

Study Completion

December 1, 2015

Last Updated

September 11, 2006

Record last verified: 2005-06

Locations

AU(13)