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.
18 Years
80 Years
Both
Gastric Cancer
Trial Information
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 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.
Inclusion Criteria:
- Patients undergoing standard gastric surgery for cancer
Exclusion Criteria:
- gallbladder disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Reduced biliary complications
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
Marco Farsi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi
Authority:
Italy: Ethics Committee
Study ID:
Firenze 1
NCT ID:
NCT00757640
Start Date:
September 2008
Completion Date:
September 2015
Related Keywords:
- Gastric Cancer
- gastric cancer, surgery, prophylactic cholecystectomy
- Stomach Neoplasms
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