E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi.

BACKGROUND: The current management of patients with gallstone disease and ductal calculi consists of endoscopic stone extraction (ESE) followed by laparoscopic cholecystectomy (LC). Following the advent of techniques of laparoscopic ductal stone clearance, an alternative single-stage laparoscopic treatment was introduced for these patients. The European Association of Endoscopic Surgery (E.A. E.S.) set up a ductal stone trial to compare the relative efficacy and outcome of these two management options.
METHODS: A prospective randomized controlled clinical trial compared two management options. Group A (n = 150) received preoperative endoscopic retrograde cholangiography (ERC) with ESE followed by LC during the same hospital admission, and group B (n = 150) received single-stage laparoscopic management.
RESULTS: There were no significant differences between the two groups in the clinical demographic details and the pretreatment biochemical findings. In group A, 14 of 150 patients received single-stage treatment; in group B, 17 of 150 were managed by the two-stage approach (protocol violation = 31/300, 10%). In group A patients managed in accordance with randomization, ERC was successful in 129/136 (95%) and preoperative ESE succeeded in 82/98 (84%) with ductal calculi detected by the ERC. Two patients had malignancies and one refused surgery. Thus, 133 patients underwent surgery. Of this group, 116 had LC only and 17 had LC and attempted laparoscopic duct exploration. There were eight conversions to open surgery (6%), 17 complications for both stages (12.8%), and two postoperative deaths (1.5%). In group B patients managed in accordance with randomization, intraoperative cholangiography was successful in 132/133 (99%). Twenty-one (16%) had normal findings, ductal calculi were found in 109, and other pathology was noted in two (periampullary cancer, severe pancreatitis). These two patients and one other (who had gross adhesion in the triangle of Calot) were converted at the start of the procedure. Transcystic ductal stone clearance was successful in 45 of 56 patients (80%), and laparoscopic direct common duct (CBD) exploration was successful in 47 of 55 patients (85%). This group includes 53 patients who underwent primary direct exploration and two failed attempts at transcystic extraction. The conversion rate was 13%. Postoperative complications were encountered in 21 patients (15.8%), and one patient died of a major myocardial infarction (0. 75%). The one postoperative death and the 10/11 biliary complications occurred in the laparoscopic supraduodenal CBD exploration subgroup. The conversion rate was higher in group B (17 vs eight; p = 0.08). Laparotomy in the postoperative period was required in three patients in group A and four patients in group B. The group B patients were in hospital for 3 days less than patients who had two-stage management (median, 6.0, IQR = 4.25-12 vs median, 9.0, IQR = 5.5-14; p < 0.05).
CONCLUSIONS: The results demonstrate equivalent success rates and patient morbidity for the two management options but a significantly shorter hospital stay with the single-stage laparoscopic treatment. The findings indicate that in fit patients (ASA I and II), single-stage laparoscopic treatment is the better option, and preoperative ESE should be confined to poor-risk patients-i.e., those with cholangitis or severe pancreatitis.

RCT Entities:   Population Interventions Outcomes