BACKGROUND AND STUDY AIMS: The main complications of endoscopic sphincterotomy are pancreatitis, hemorrhage, perforation and cholangitis. In a prospective randomized trial, a conventional current generator was compared to a new generator with an automatically controlled cut system (Endocut) for sphincterotomy. The purpose was to establish whether the new device reduces the complication rate of sphincterotomy. Our experiences over the last 2 years with the new HF current generator are described here. PATIENTS AND METHODS: In this study 100 patients were randomly assigned to one of the two generators. The following points were documented in a protocol form: abrupt or continuous cutting; length of papillotomy; complications. RESULTS: There were no significant differences in sex, age or indication for sphincterotomy. Nor were there any significant differences in the length of the sphincterotomy or mild pancreatitis. In contrast, an abrupt opening of the papillary roof was more frequently observed with the conventional generator (18 patients) than with the new device (one patient, P < 0.001). Mild bleeding occurred in two patients with the new unit, but in 13 with the conventional unit (P = 0.002). Moderate or severe bleeds were observed in neither of the two groups. During the subsequent application phase lasting for 2 years, the following complications occurred in a total number of 850 sphincterotomies (EST): pancreatitis 2.8% (one patient died); hemorrhages requiring transfusion 1% (n = 8); concealed perforations 0.3% (n = 3). CONCLUSIONS: According to our experience to date and based on this study, this new HF surgery unit enables performance of controlled, bloodless sphincterotomies. The danger of papillary hemorrhage appears to be reduced. All examiners found the new system to be safer and more convenient.
RCT Entities:
BACKGROUND AND STUDY AIMS: The main complications of endoscopic sphincterotomy are pancreatitis, hemorrhage, perforation and cholangitis. In a prospective randomized trial, a conventional current generator was compared to a new generator with an automatically controlled cut system (Endocut) for sphincterotomy. The purpose was to establish whether the new device reduces the complication rate of sphincterotomy. Our experiences over the last 2 years with the new HF current generator are described here. PATIENTS AND METHODS: In this study 100 patients were randomly assigned to one of the two generators. The following points were documented in a protocol form: abrupt or continuous cutting; length of papillotomy; complications. RESULTS: There were no significant differences in sex, age or indication for sphincterotomy. Nor were there any significant differences in the length of the sphincterotomy or mild pancreatitis. In contrast, an abrupt opening of the papillary roof was more frequently observed with the conventional generator (18 patients) than with the new device (one patient, P < 0.001). Mild bleeding occurred in two patients with the new unit, but in 13 with the conventional unit (P = 0.002). Moderate or severe bleeds were observed in neither of the two groups. During the subsequent application phase lasting for 2 years, the following complications occurred in a total number of 850 sphincterotomies (EST): pancreatitis 2.8% (one patient died); hemorrhages requiring transfusion 1% (n = 8); concealed perforations 0.3% (n = 3). CONCLUSIONS: According to our experience to date and based on this study, this new HF surgery unit enables performance of controlled, bloodless sphincterotomies. The danger of papillary hemorrhage appears to be reduced. All examiners found the new system to be safer and more convenient.