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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Laparoscopic
Common Bile Duct Stone With Chronic Cholecystitis

Treatments

Procedure: Laparoscopic common bile duct exploration.

Study type

Observational

Funder types

Other

Identifiers

NCT04467710
RECHMPL20_0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

222 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

222 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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