BACKGROUND: It has been suggested that the use of pure-cut electrosurgical current for endoscopic sphincterotomy may reduce the risk of post-ERCP pancreatitis. The aim of this study was to determine whether pure-cut current reduces the risk of pancreatitis compared with blend current. METHODS: Patients were randomly assigned to undergo sphincterotomy over a non-conductive guidewire with 30 W/sec pure-cut current or 30 W/sec blend-2 current by a blinded endoscopist. Serum amylase and lipase levels were determined 1 day before and within 24 hours after ERCP. Post-ERCP pancreatitis was the primary outcome of interest. Secondary outcomes were as follows: severity of immediate bleeding, as graded by a 3-point scale from 1 (no bleeding) to 3 (injection or balloon tamponade therapy required to stop bleeding) and evidence of delayed bleeding 24 hours after ERCP. Analyses were performed in intention-to-treat fashion. RESULTS: A total of 246 patients were randomized (116 pure-cut current, 130 blend current). There were no differences in baseline characteristics between the groups. The overall frequency of post-ERCP pancreatitis was 6.9%, with no significant difference in frequency between treatment arms (pure cut, 7.8% vs. blend, 6.1%; p = 0.62). The difference in rates of pancreatitis between the two groups was 1.7%: 95% CI[-4.8%, 8.2%]. Six patients (2.4%) had delayed bleeding after ERCP, of which two required transfusion. There was a significant increase in minor bleeding episodes (grade 2) in the pure-cut group (p < 0.0001). Delayed episodes of bleeding were equal (n = 3) in each arm. CONCLUSIONS: The type of current used when performing endoscopic sphincterotomy does not appear to alter the risk of post-ERCP pancreatitis. The selection of electrosurgical current for biliary endoscopic sphincterotomy should be based on endoscopist preference.
RCT Entities:
BACKGROUND: It has been suggested that the use of pure-cut electrosurgical current for endoscopic sphincterotomy may reduce the risk of post-ERCP pancreatitis. The aim of this study was to determine whether pure-cut current reduces the risk of pancreatitis compared with blend current. METHODS:Patients were randomly assigned to undergo sphincterotomy over a non-conductive guidewire with 30 W/sec pure-cut current or 30 W/sec blend-2 current by a blinded endoscopist. Serum amylase and lipase levels were determined 1 day before and within 24 hours after ERCP. Post-ERCP pancreatitis was the primary outcome of interest. Secondary outcomes were as follows: severity of immediate bleeding, as graded by a 3-point scale from 1 (no bleeding) to 3 (injection or balloon tamponade therapy required to stop bleeding) and evidence of delayed bleeding 24 hours after ERCP. Analyses were performed in intention-to-treat fashion. RESULTS: A total of 246 patients were randomized (116 pure-cut current, 130 blend current). There were no differences in baseline characteristics between the groups. The overall frequency of post-ERCP pancreatitis was 6.9%, with no significant difference in frequency between treatment arms (pure cut, 7.8% vs. blend, 6.1%; p = 0.62). The difference in rates of pancreatitis between the two groups was 1.7%: 95% CI[-4.8%, 8.2%]. Six patients (2.4%) had delayed bleeding after ERCP, of which two required transfusion. There was a significant increase in minor bleeding episodes (grade 2) in the pure-cut group (p < 0.0001). Delayed episodes of bleeding were equal (n = 3) in each arm. CONCLUSIONS: The type of current used when performing endoscopic sphincterotomy does not appear to alter the risk of post-ERCP pancreatitis. The selection of electrosurgical current for biliary endoscopic sphincterotomy should be based on endoscopist preference.