Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration

University Hospitals (UH)

Status: Completed

Conditions: Cholecystitis; Cholangitis; Gallstone Migration; Choledocholithiasis; Gallstone Pancreatitis

Treatments: Procedure: Cholecystectomy with intraoperative cholangiogram

Study type: Observational

Funder types: Other

Identifiers

NCT02461147

CCK first validation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

161 participants in 1 patient group

Validation cohort

Description:

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.

Treatment:

Procedure: Cholecystectomy with intraoperative cholangiogram