Randomized Control Trial of EST with Either Endocut Mode or Conventional Pure Cut Mode

Abstract

INTRODUCTION & AIM After endoscopic sphincterotomy (EST) were developed by Kawai K, Classen M, and Sohma T, individually, endoscopic removal of bile duct stone has been accepted as a standard treatment because of its less invasiveness, short hospital stay, and cost effectiveness etc. Furthermore while the era of laparoscopic cholecystectomy has come, the endoscopic treatment has much importance clinically. However 1-3% complication of bleeding after EST with conventional pure cutting current has been reported. Recently endocut mode of ERBE has been introduced in clinical fields. The aim of this study is to access the usefulness and complications of endocut mode on EST, compared with conventional pure cutting current. SUBJECTS & METHODS From June, 2002 up to now, a randomized control trial has been performed prospectively in 84 patients (M:F=41:36, averaged age 66.2 y/o) who were consisted of 46 bile duct stone, 15 pancreas cancer, 11 cholangiocarcinoma, 5 bile duct cancer, 2 gall blladder cancer, 2 chronic pancreatitis, and 3 others. These patients were assigned to receive EST with either endocut mode (EC group: 41 pts) or conventional high frequency pure cut current (HF group: 43 pts). Then quality of cutting (smooth, hard, zipper, perforation) and complication such as bleeding and pancreatitis after EST were investigated in this study. SUMMARY of RESULTS There was no significant difference on background such as, age, sex distribution, original disease, and aim of procedure in both EC and HC group. Smooth, hard, and zipper cut was occurred 41 (100%), 0 , 0 in EC group and 38 (88%), 4 (9%), 1 (2%) in HF group, respectively. And there was no perforation case in both groups. No bleeding, oozing, massive oozing, massive bleeding requiring hemostasis were recorded 28 (68%), 12 (29%), 0, 1(2%) in EC group and 15 (35%), 20 (47%), 2 (5%), 6 (14%) in HC group, respectively. And hyperamylasemia, mild pancreatitis, and severe pancreatitis (Cotton's classification) were occurred 29% (12/41), 10% (4/41) in EC and 12% (5/43), 2% (1/43) in HF group, respectively. CONCLUSIONS We concluded that EST were more smoothly performed with endocut mode (EC) and the incidence of bleeding requiring hemostasis is significantly lower with endocut mode EST, compared to high frequency pure current (HF). There is a significant difference on hyperamylasemia after EST between EC and HF, and is a tendency to occur pancreatitis after EST. However further investigations with big number of subjects will be needed in order to confirm these results.