Laparoscopic Treatment of Common Bile Duct Stones : What Are the Limits and When Should we Call the Endoscopist ?

Completed

• Conditions: Common Bile Duct Stone With Chronic Cholecystitis; Laparoscopic
• Interventions: Procedure: Laparoscopic common bile duct exploration.

• Registration Number: NCT04467710
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.

Detailed Description

Lithiasis disease represents a real public health problem. Indeed, 10% of the general population is asymptomatic carrier of gallbladder stones and among them, 35% will present a symptomatic form which will cause the indication of cholecystectomy. As a result, around 120,000 cholecystectomies are performed per year in France, and around 750,000 in the United States for this indication. Cholecystectomy is therefore the most widely performed procedure in the world. However, in 3 to 20% of cases, common bile duct stones will be associated and to be treated. Different strategies are proposed: a treatment called "all surgical" or an endoscopic treatment (usually a sphincterotomy) before, after or during a cholecystectomy. The investigators defined two groups of patients: one group with success of fully laparoscopic surgical treatment (cholecystectomy and laparoscopic exploration of the common bile duct at the same time), and one group treated by laparoscopic cholecystectomy and management of the common bile duct stone(s) by an ERCP performed intra, per ou postoperatively. The primary outcome was the failure of surgical management, defined as the requirement of ERCP for extraction of common bile duct stones, which permit us to identify risk factors of failure in the fullfil surgical treatment process. The secondary outcome was to study the morbimortality in each group, and length of stay.

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-06-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Success of LCBDE	Laparoscopic common bile duct exploration.	Patients with a fully laparoscopic surgical treatment of common bile duct stones
Failure of LCBDE	Laparoscopic common bile duct exploration.	Patients with a laparoscopic cholecystectomy but an endoscopic treatment of common bile duct stone with an ERCP performed intra, per or postoperatively

Primary Outcome Measures

Name	Time	Method
morbimortality	1 day	Clavien dindo classification

Secondary Outcome Measures

Name	Time	Method
risk factors of total laprascopic treatment failure.	1 day	risk factors of total laprascopic treatment failure.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France