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Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration

NCT ID: NCT02461147

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-06-30

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.

Conditions

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Choledocholithiasis Gallstone Migration Cholecystitis Gallstone Pancreatitis Cholangitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Validation cohort

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

Intervention Type PROCEDURE

cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Pouya Iranmanesh

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pouya Iranmanesh, MD

Role: PRINCIPAL_INVESTIGATOR

Geneva University Hospital, Division of Digestive Surgery

Christian Toso, MD-PhD

Role: STUDY_DIRECTOR

Geneva University Hospital, Division of Digestive Surgery

Locations

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Geneva University Hospital

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 25005650 (View on PubMed)

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.

Reference Type RESULT
PMID: 25399287 (View on PubMed)

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.

Reference Type RESULT
PMID: 25451659 (View on PubMed)

Other Identifiers

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CCK first validation

Identifier Type: -

Identifier Source: org_study_id