Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration

Completed

• Conditions: Choledocholithiasis; Cholecystitis; Gallstone Pancreatitis; Cholangitis; Gallstone Migration
• Interventions: Procedure: Cholecystectomy with intraoperative cholangiogram

• Registration Number: NCT02461147
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• Admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis)

Exclusion Criteria

• Severe sepsis or septic shock
• contra-indication to surgery
• previous surgery interfering with common bile duct assessment procedures (roux-en-y gastric bypass, etc.)
• previous cholecystectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation cohort	Cholecystectomy with intraoperative cholangiogram	All patients of the study (single group, single arm) will undergo initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, according to the standard protocol of treatment previously implemented at the investigators institution.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay [days]	1-100 days

Secondary Outcome Measures

Name	Time	Method
Common bile duct clearance rate [%]	This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days	Percentage of patients where common bile duct (CBD) clearance was achieved after ERCP (did not require surgical exploration because of ERCP failure)
Morbidity	From admission up to 6 months after hospital discharge	Morbidity will be assessed for each patient according to the Dindo-Clavien classification of surgical complications, including death.
Number of common bile duct investigations [N]	Anytime during hospital stay, an expected average of 7 days	These include number of endoscopic ultrasounds (EUS), magnetic cholangio-pancreatography (MRCP) and endoscopic retrograde cholangio-pancreatography (ERCP) performed during the patient's hospital stay

Trial Locations

Locations (1)

Geneva University Hospital; 🇨🇭 Geneva, Switzerland