Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery (CHOLEGAS)

February 10, 2021 updated by: Bencini Lapo, Italian Research Group for Gastric Cancer

The CHOLEGAS Study: Multicentric Randomized, Double-blinded, Controlled Trial of Gastrectomy Plus Prophylactic Cholecystectomy Versus Gastrectomy Only, in Adults Submitted to Gastric Cancer Surgery With Curative Intent.

The patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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

  • Italy
      • Florence, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica

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 to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing standard gastric surgery for cancer

Exclusion Criteria:

  • gallbladder disease

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: B
no cholecystectomy
Experimental: A
cholecystectomy
Procedure: cholecystectomy
prophylactic cholecystectomy during standard gastric surgery for cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduced biliary complications
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved quality of life
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Italian Research Group for Gastric Cancer

Collaborators

Azienda Ospedaliero-Universitaria Careggi

Investigators

  • Principal Investigator: Marco Farsi, MD, Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi

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

Helpful Links

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, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 20, 2008

First Submitted That Met QC Criteria

September 20, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Firenze 1

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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