Overview

This trial is active, not recruiting.

Conditions choledocholithiasis, gallstone migration, cholecystitis, gallstone pancreatitis, cholangitis
Treatment cholecystectomy with intraoperative cholangiogram
Sponsor University Hospital, Geneva
Start date September 2013
End date January 2016
Trial size 500 participants
Trial identifier NCT02461147, CCK first validation

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
Length of hospital stay [days]
time frame: 1-100 days

Secondary Outcomes

Measure
Number of common bile duct investigations [N]
time frame: Anytime during hospital stay, an expected average of 7 days
Common bile duct clearance rate [%]
time frame: This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days
Morbidity
time frame: From admission up to 6 months after hospital discharge

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis
Principal investigator Pouya Iranmanesh, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.