Clinical trial NCT02461147: Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
Official title: Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis
Gallstone Migration
Cholecystitis
Gallstone Pancreatitis
Cholangitis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 161
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted through the emergency department for an acute gallstone-related condition.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay [days]
timeFrame: 1-100 days
Secondary outcomes:
measure: Number of common bile duct investigations [N]
timeFrame: Anytime during hospital stay, an expected average of 7 days
measure: Common bile duct clearance rate [%]
timeFrame: This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days
measure: Morbidity
timeFrame: From admission up to 6 months after hospital discharge
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: Geneva University Hospital, Division of Digestive Surgery
name: Pouya Iranmanesh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geneva University Hospital, Division of Digestive Surgery
name: Christian Toso, MD-PhD
role: STUDY_DIRECTOR
References:
citation: Iranmanesh P, Frossard JL, Mugnier-Konrad B, Morel P, Majno P, Nguyen-Tang T, Berney T, Mentha G, Toso C. Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent cholecystectomy for suspected gallstone migration: a randomized clinical trial. JAMA. 2014 Jul;312(2):137-44. doi: 10.1001/jama.2014.7587.
citation: Iranmanesh P, Frossard JL, Toso C. Treatment for patients at intermediate risk of a common duct stone--reply. JAMA. 2014 Nov 19;312(19):2043-4. doi: 10.1001/jama.2014.13425. No abstract available.
citation: Iranmanesh P, Frossard JL, Toso C. Reply: To PMID 25451658. Gastroenterology. 2015 Jan;148(1):252. doi: 10.1053/j.gastro.2014.11.016. Epub 2014 Nov 21. No abstract available.