NCT02461147

Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration

Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 161 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has been implemented at the investigators institution as the standard management strategy for patients at intermediate risk of common bile duct stone migration, following a randomized controlled trial previously published by the same investigators team. The aim of this study is to prospectively analyze the outcomes of this strategy.

Detailed description

A previous randomized controlled trial comparing initial cholecystectomy with intraoperative cholangiogram (IOC) versus common bile duct (CBD) assessment and subsequent cholecystectomy for patients admitted in the emergency room with an acute gallstone-related condition and with an intermediate risk of common bile duct stone was performed by the investigators. This study had been registered on Clinicaltrials.gov as well and had shown that a strategy with initial cholecystectomy significantly decreased the length of hospital stay and the number of CBD investigations procedures. Initial cholecystectomy with IOC is now the standard management strategy for these patients in the investigators hospital. The goal of this study is to perform a prospective validation of this strategy and to analyze if the results obtained in the previously mentioned randomized controlled trial are confirmed on a larger patients cohort. This study will be observational, since the intervention (initial cholecystectomy) is not assigned by the investigators, but is already a standard treatment strategy at our institution.

Conditions

• Choledocholithiasis
• Gallstone Migration
• Cholecystitis
• Gallstone Pancreatitis
• Cholangitis

Interventions

Type	Name	Description
PROCEDURE	Cholecystectomy with intraoperative cholangiogram	cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2015-06-03
• Last updated: 2020-11-04

Locations

1 site across 1 country: Switzerland