BACKGROUND:Complications after endoscopic biliary sphincterotomy occur in 8% to 10% of patients when studied prospectively. It is not known whether the type of electrocautery current affects this rate. Theoretically, less edema of the ampulla after a pure cutting current sphincterotomy could decrease the risk of pancreatitis although the risk of postsphincterotomy hemorrhage might be greater. METHODS:One hundred seventy patients undergoing sphincterotomy were prospectively randomized to either a blended or pure cut current on the Valleylab electrosurgical unit. The settings were a blended three current at a power setting of 30 watts/sec for both the cut and coagulation currents or a pure cut current at a power setting of 30 watts/sec. The individual determining whether a complication occurred was blinded to the type of current used, and all patients were hospitalized for 24 hours post-procedure. Pancreatitis was defined as mild if fewer than 5 days, moderate if 5 to 14 days, and severe if more than 14 days of hospitalization were required. RESULTS: Indications for sphincterotomy were choledocholithiasis in 111 patients, sphincter of Oddi dysfunction in 36 patients, stent placement in 15 patients, and miscellaneous in 8 patients. There were a total of 16 complications in 170 patients (9%); 4 (5%) were in the pure cut current group of 86 patients (one episode of bleeding that required transfusion of 4 U and three episodes of mild pancreatitis), and 12 (14%) were in the blended current group of 84 patients (7 mild, 2 moderate, and 1 severe pancreatitis; 1 case of cholangitis; and one episode of bleeding that required transfusion of 2 U). There were significantly fewer complications in the pure cut group (p < 0.05 by chi-square). CONCLUSION: The use of pure cut current is associated with a lower incidence of pancreatitis, the most common ERCP complication, than with blended current sphincterotomy. An insufficient number of patients were studied to comment on the relative risk of hemorrhage. However, because the complication of hemorrhage is much less common than pancreatitis, pure cut current is safer overall.
RCT Entities:
BACKGROUND: Complications after endoscopic biliary sphincterotomy occur in 8% to 10% of patients when studied prospectively. It is not known whether the type of electrocautery current affects this rate. Theoretically, less edema of the ampulla after a pure cutting current sphincterotomy could decrease the risk of pancreatitis although the risk of postsphincterotomy hemorrhage might be greater. METHODS: One hundred seventy patients undergoing sphincterotomy were prospectively randomized to either a blended or pure cut current on the Valleylab electrosurgical unit. The settings were a blended three current at a power setting of 30 watts/sec for both the cut and coagulation currents or a pure cut current at a power setting of 30 watts/sec. The individual determining whether a complication occurred was blinded to the type of current used, and all patients were hospitalized for 24 hours post-procedure. Pancreatitis was defined as mild if fewer than 5 days, moderate if 5 to 14 days, and severe if more than 14 days of hospitalization were required. RESULTS: Indications for sphincterotomy were choledocholithiasis in 111 patients, sphincter of Oddi dysfunction in 36 patients, stent placement in 15 patients, and miscellaneous in 8 patients. There were a total of 16 complications in 170 patients (9%); 4 (5%) were in the pure cut current group of 86 patients (one episode of bleeding that required transfusion of 4 U and three episodes of mild pancreatitis), and 12 (14%) were in the blended current group of 84 patients (7 mild, 2 moderate, and 1 severe pancreatitis; 1 case of cholangitis; and one episode of bleeding that required transfusion of 2 U). There were significantly fewer complications in the pure cut group (p < 0.05 by chi-square). CONCLUSION: The use of pure cut current is associated with a lower incidence of pancreatitis, the most common ERCP complication, than with blended current sphincterotomy. An insufficient number of patients were studied to comment on the relative risk of hemorrhage. However, because the complication of hemorrhage is much less common than pancreatitis, pure cut current is safer overall.