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

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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic; Common Bile Duct Stone With Chronic Cholecystitis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 222

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients aged more than 18, hospitalized in Montpellier University Hospital between 2007 and 2019 requiring a laparoscopic cholecystectomy for symptomatic biliary disease associated to a common bile duct stone highlighted on preoperative imaging or intraoperative cholangiography, which will be treated surgically or endoscopically during the same hospital stay.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbimortality	Clavien dindo classification	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk factors of total laprascopic treatment failure.	risk factors of total laprascopic treatment failure.	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: ERCP; Common bile duct stones; Morbimortality; Laparoscopic common bile duct exploration (LCBDE)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Calculi
• Other Study ID Numbers: RECHMPL20_0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No