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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Reduced biliary complications
Marco Farsi, MD
Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi
Italy: Ethics Committee