Clinical trial NCT04467710: Laparoscopic Treatment of Common Bile Duct Stones : What Are the Limits and When Should we Call the Endoscopist ?
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic
Common Bile Duct Stone With Chronic Cholecystitis
Keywords: Common bile duct stones
Laparoscopic common bile duct exploration (LCBDE)
ERCP
Morbimortality
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: morbimortality
timeFrame: 1 day
Secondary outcomes:
measure: risk factors of total laprascopic treatment failure.
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Astrid HERRERO, MD, PHD
role: STUDY_DIRECTOR
References: