Original article
A Randomized Trial of Endoscopic Biliary Sphincterotomy Using Pure-Cut Versus Combined Cut and Coagulation Waveforms

https://doi.org/10.1016/S1542-3565(05)00528-8Get rights and content

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.

Section snippets

Study Design

A prospective, multicenter, randomized trial was performed. Patients were stratified into low- or high-risk groups for post–endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. High-risk patients were defined as having 1 or more of the following: previous post-ERCP pancreatitis, ampullary tumor, suspected sphincter of Oddi dysfunction, biliary manometry, or difficult cannulation—defined as greater than 20 minutes required to achieve deep cannulation of the common bile duct.

Results

A total of 267 patients were included in the study, 133 underwent ES using the cut/coag waveform and 134 underwent ES using the pure-cut output. The patients were well matched with regard to all parameters examined (Table 1). In particular, there were 26 and 24 high-risk patients in the cut/coag and pure-cut groups, respectively. The incision was completed with the assigned generator in all cases. There were no instances of stalling or failed incision with either generator. However, there were

Discussion

Therapeutic ERCP is a relatively common procedure that has significant potential for morbidity. The characteristics of the electrosurgical injury to the ampulla may impact on the frequency of complications. This prospective study reports and compares the complication profile related to the use of fundamentally new electrosurgical generators for performance of endoscopic biliary sphincterotomy. There are no prospective trials comparing new feedback generators with the previous fixed-output

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