Late Complications of Endoscopic Sphincterotomy in Comparison to Endoscopic Papillary Balloon Dilation in Patients with Bile Duct Stones: A Randomized Controlled Multicenter Trial

Abstract

Although endoscopic sphincterotomy (EST) is a well-established standard treatment for common bile duct stones, the papillary function is damaged after this treatment. However, it remains unclear whether or not the reduced papillary function causes any late clinical complications. On the other hand, endoscopic papillary balloon dilation (EPBD) is another option for the extraction of bile duct stones, and the papillary function is preserved better than after EST. Aim: To compare the long-term complications between EST and EPBD for stone removal. Methods: From March 2000 to March 2001, a randomized, controlled multicenter trial was carried out at 11 institutions in Japan. Two hundred eighty-two patients with bile duct stones smaller than 14 mm in size were randomly assigned to EST and EPBD groups. The follow-up data of them, 144 patients after EST and 138 patients after EPBD, were collected. Results: The baseline characteristics of the patients were similar between the two groups. The gall bladder was left in situ after the treatment in 72 patients (50%) from the EST group and in 55 patients (40%) from the EPBD group, and gall bladder stones remained in 38 patients (26%) from the EST group and in 31 patients (22%) from the EPBD group. The median duration of the follow-up was 2,451 days and 2,409 days, for the EST group and the EPBD group, respectively. Morbidity was observed in 40 patients (28%) and 18 patients (13%), from the EST group and the EPBD group, respectively. Such morbidity included: recurrent bile duct stones in 25 and 12; cholangitis without stone recurrence in 3 and none; liver abscess in 2 and none; cholecystitis in 6 and 3; and new appearance of gall bladder stones in 5 and 4, respectively. One patient of the EST group died due to sepsis from liver abscess. Gall bladder cancer was found in one patient 561 days after undergoing EST. A Kaplan-Meier analysis revealed a significantly lower incidence of biliary complications such as recurrent bile duct stones and cholangitis in the EPBD group than in the EST group. Conclusions: The occurrence of papillary dysfunction after EST may therefore result in additional late complications during the long-term follow-up.