Prospective Validation of Cholecystectomy First Strategy for Gallstone Migration

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholecystitis, Choledocholithiasis, Gallstone Migration, Gallstone Pancreatitis, Cholangitis

Intervention / Treatment
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* Procedure: Cholecystectomy with intraoperative cholangiogram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Validation cohort<br>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. | Procedure: Cholecystectomy with intraoperative cholangiogram<br>* cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay [days] |  | 1-100 days | 

Secondary Outcome Measures

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