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NCT00757640 Clinical Trial

Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

Gastric Cancer Clinical Trial

— CHOLEGAS  

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00757640
Other study ID # Firenze 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2008
Est. completion date September 2015

Study information
Verified date February 2021
Source Italian Research Group for Gastric Cancer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date September 2015
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients undergoing standard gastric surgery for cancer Exclusion Criteria: - gallbladder disease

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cholecystectomy
prophylactic cholecystectomy during standard gastric surgery for cancer

Locations
Country Name City State
Italy Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica Florence

Sponsors (2)
Lead Sponsor Collaborator
Italian Research Group for Gastric Cancer Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduced biliary complications 5 years
Secondary Improved quality of life 5 years
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