A randomized trial of endoscopic biliary sphincterotomy using pure-cut versus combined cut and coagulation waveforms

Background & Aims: Endoscopic biliary sphincterotomy has complication rates of 5%-12%. The output from the electrosurgical generator may influence the degree of coagulation and the rapidity of the incision, and thus rates of pancreatitis, hemorrhage, and perforation. Some modern generators incorporate feedback control to standardize output and automate the alternating cut and coagulation modes. Our aim was to compare 2 feedback-controlled generators, one with constant pure cutting-type output and the other with an alternating cut and coagulation mode. Methods: In this multicenter randomized study, 133 patients were assigned to the alternating cut/coag output and 134 patients were assigned to constant pure-cut output. Patients were stratified by their risk for pancreatitis. Results: The overall pancreatitis rate was 1.5%, including 3 patients in the cut/coag group and 1 patient in the pure-cut group (P > .05). There were 11 poorly controlled (zipper) incisions in the pure-cut group and none in the cut/coag group (P = .02). The incision was completed in all patients without stalling. Immediate hemorrhage occurred in 35 pure-cut patients and 8 cut/coag patients output (P = .002). There were no episodes of clinically significant bleeding, delayed bleeding, or perforation. Conclusions: Biliary sphincterotomy using feedback-controlled generators results in dependable progression of incision with a low pancreatitis rate. Control of the incision is improved subjectively with the cut/coagulation output, but this did not translate into a difference in clinically significant complications.