Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration

Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461147
• Other study ID #: CCK first validation
• Status: Completed
• Start date: September 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Cholecystitis
• Cholecystolithiasis
• Choledocholithiasis
• Cholelithiasis
• Gallstone Migration
• Gallstone Pancreatitis
• Gallstones
• Pancreatitis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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 randomize — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay [days]		1-100 days
Secondary	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
Secondary	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
Secondary	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