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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04467710
Enrollment
222
Registered
2020-07-13
Start date
2007-01-01
Completion date
2020-06-01
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Bile Duct Stone With Chronic Cholecystitis, Laparoscopic

Keywords

Common bile duct stones, Laparoscopic common bile duct exploration (LCBDE), ERCP, Morbimortality

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.

Interventions

PROCEDURELaparoscopic 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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
morbimortality1 dayClavien dindo classification

Secondary

MeasureTime frameDescription
risk factors of total laprascopic treatment failure.1 dayrisk factors of total laprascopic treatment failure.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026