Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration

November 2, 2020 updated by: Pouya Iranmanesh, University Hospital, Geneva

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Geneva University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted through the emergency department for an acute gallstone-related condition.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of common bile duct investigations [N]
Time Frame: Anytime during hospital stay, an expected average of 7 days
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 [%]
Time Frame: This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days
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
Time Frame: From admission up to 6 months after hospital discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Pouya Iranmanesh, MD, Geneva University Hospital, Division of Digestive Surgery
  • Study Director: Christian Toso, MD-PhD, Geneva University Hospital, Division of Digestive Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCK first validation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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