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

Laparoscopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467710
• Other study ID #: RECHMPL20_0001
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: June 1, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Cholecystitis
• Common Bile Duct Stone With Chronic Cholecystitis
• Laparoscopic

Intervention

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.

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbimortality	Clavien dindo classification	1 day
Secondary	risk factors of total laprascopic treatment failure.	risk factors of total laprascopic treatment failure.	1 day