EAES DUCTAL STONE STUDY - PRELIMINARY FINDINGS OF MULTICENTER PROSPECTIVE RANDOMIZED TRIAL COMPARING 2-STAGE VS SINGLE-STAGE MANAGEMENT

Background: The current management of patients with ductal calculi and gallstone disease consists of endoscopic stone extraction (ESE) follo wed by laparoscopic cholecystectomy (LC), The advent of techniques of laparoscopic ductal stone clearance has introduced an alternative sing le stage laparoscopic treatment for these patients. The EAES ductal st one trial was set up to compare the relative efficacy and outcome of t hese two management options. Methods: The study consists of a prospect ive randomized controlled clinical trial comparing two management opti ons of patients undergoing LC and suspected of harbouring common duct stones. Patients registered into the trial are randomized to one of tw o arms: (i) Group A-preoperative ERC with ESE followed by LC during th e same hospital admission. (ii) Group B-single stage laparoscopic mana gement consisting of LC and laparoscopic stone extraction either by th e trans-cystic duct route or by direct supraduodenal common duct explo ration. Results: This preliminary analysis was carried out on 207 rand omized patients with comparisons being made on the intention to treat principle. The two groups (A = 106, B = 101) were comparable with resp ect to clinical features. ASA grade, serum biochemistry and ultrasound findings. Conclusions: These preliminary findings indicate equivalent success rates and patient morbidity between the two management option s but a shorter hospital stay (cost benefit) with the single stage lap aroscopic treatment, Transcystic duct extraction is a more benign proc edure than laparoscopic supraduodenal CBD exploration and is accompani ed by a significantly shorter hospital stay. The higher incidence of c onversion in the single stage laparoscopic group compared to the two-s tage arm is due to the preference for open common duct exploration whe n the laparoscopic attempt failed by the majority of participating sur geons. The results to-date suggest that in fit patients, single stage laparoscopic treatment is the better option and the role of ESE should change to selective use in those patients in whom laparoscopic ductal stone extraction has failed.