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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | cholecystectomy | prophylactic 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.