Original articleA Randomized Trial of Endoscopic Biliary Sphincterotomy Using Pure-Cut Versus Combined Cut and Coagulation Waveforms
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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2020, Clinics and Research in Hepatology and GastroenterologyCitation Excerpt :Due to the high heterogeneity and absence of outlier studies, we used random effect. From the 3 previous articles [28,29,32], two (total of 353 patients) stratified by severity of pancreatitis, allowing subgroup analysis. There was no statistical difference for the subgroups mild (RD: 0.01 [−0.01, 0.03], P = 0.42, I2 = 0%), moderate (RD: 0.02 [−0.01, 0.04], P = 0.14, I2 = 48%), or severe pancreatitis (RD: 0.00 [−0.01, 0.02], P = 0.65, I2 = 0%).
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