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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04467710
Collaborator
(none)
222
1
161
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic common bile duct exploration.

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 Design

Study Type:
Observational
Actual Enrollment :
222 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Treatment of Common Bile Duct Stones in a Laparoscopic Center : What Are the Limits and When Should we Call the Endoscopist ? Observationnal Study Between 2007-2019
Actual Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Success of LCBDE

Patients with a fully laparoscopic surgical treatment of common bile duct stones

Procedure: Laparoscopic common bile duct exploration.
Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct. ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time.

Failure of LCBDE

Patients with a laparoscopic cholecystectomy but an endoscopic treatment of common bile duct stone with an ERCP performed intra, per or postoperatively

Procedure: Laparoscopic common bile duct exploration.
Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct. ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time.

Outcome Measures

Primary Outcome Measures

  1. morbimortality [1 day]

    Clavien dindo classification

Secondary Outcome Measures

  1. risk factors of total laprascopic treatment failure. [1 day]

    risk factors of total laprascopic treatment failure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
  • More than 18 years old

  • Between 2007 and 2019

  • Montpellier University Hospital

  • Laparoscopic cholecystectomy for symptomatic cholelithiasis associated to common bile duct stones

  • Common bile duct stones highlighted on preoperative imaging or intraoperative cholangiography

  • Common bile duct stones treated during the same hospital stay surgically or endocopically

Exclusion criteria:
  • Laparotomy

  • Previous ERCP

  • Less than 18 years old

  • Lost to follow up

  • Lack of data > 10%

  • Other surgical procedure associated at the same time

  • Previous cholecystectomy

  • Caroli's disease

  • Severe cholangitis or acute pancreatitis

  • Pigmentary or hydatic lithiasis

  • Laparoscopic cholecystectomy for other indication than symptomatic cholelithiasis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uhmontpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Study Director: Astrid HERRERO, MD, PHD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04467710
Other Study ID Numbers:
  • RECHMPL20_0001
First Posted:
Jul 13, 2020
Last Update Posted:
Sep 3, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 3, 2020