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

NCT ID: NCT04467710

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 222 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-01
• Study Completion Date: 2020-06-01

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.

Conditions

Laparoscopic; Common Bile Duct Stone With Chronic Cholecystitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Success of LCBDE

Patients with a fully laparoscopic surgical treatment of common bile duct stones

Laparoscopic common bile duct exploration.

Intervention Type: PROCEDURE

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

Laparoscopic common bile duct exploration.

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid HERRERO, MD, PHD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

References

Genet D, Souche R, Roucaute S, Borie F, Millat B, Valats JC, Fabre JM, Herrero A. Upfront Laparoscopic Management of Common Bile Duct Stones: What Are the Risk Factors of Failure? J Gastrointest Surg. 2023 Sep;27(9):1846-1854. doi: 10.1007/s11605-023-05687-9. Epub 2023 Apr 27.

Reference Type: DERIVED

PMID: 37106206 (View on PubMed)

Other Identifiers

RECHMPL20_0001

Identifier Type: -

Identifier Source: org_study_id