The Cholegas Study: safety of prophylactic cholecystectomy during gastrectomy for cancer: preliminary results of a multicentric randomized clinical trial

Background Cholelithiasis is more frequent in patientsafter gastrectomy, due to dissection of vagal branches andgastrointestinal reconstruction.Methods A randomized controlled trial was conductedfrom November 2008 to March 2012. Patients were randomizedinto two groups: prophylactic cholecystectomy(PC) and standard gastric surgery only (SS) for curablecancers. We planned three end points: evaluation of thenumber of patients who developed symptoms and neededfurther surgery for cholelithiasis after standard gastriccancer surgery, evaluation of the incidence of cholelithiasisoverall after standard gastric cancer surgery and perioperativecomplications or costs of prophylactic cholecystectomy.The present study answers to the last end point only.Results After 40 months from the beginning of study,172 patients were eligible from 9 Centers. Ten patientsrefused consent and 32 were excluded due to flawing ofinclusion criteria (not confirmed adenocarcinomas and noR0 surgery). Therefore, final analysis included 130 patients:65 in PC group and 65 in SS. Among PC group, 12 patientshad surgical complications during the perioperative period;only 1 biliary leakage, conservatively treated, might havebeen caused by prophylactic cholecystectomy. 6 patientshad surgical complications in SS group. One postoperativedeath occurred in PC group due to pulmonary embolism.Differences were not statistically significant. Similarly, nodifferences were significant in duration of surgery, bloodloss, hospital stay.Conclusions Concomitant cholecystectomy during standardsurgery for gastric malignancies seemed to add noextra perioperative morbidity, mortality and costs to thesample included in the study.