Clinical Trials Directory

Trials / Completed

CompletedNCT00757640

Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Italian Research Group for Gastric Cancer · Network
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcholecystectomyprophylactic cholecystectomy during standard gastric surgery for cancer

Timeline

Start date
2008-09-01
Primary completion
2010-09-01
Completion
2015-09-01
First posted
2008-09-23
Last updated
2021-02-15

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00757640. Inclusion in this directory is not an endorsement.

Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery (NCT00757640) · Clinical Trials Directory