Randomized Control Trial of EST By Either PSD with 1/2 Burning Effect Setting of Endocut Mode or Conventional Endocut Mode

Abstract

Randomized Control Trial of EST By Either PSD with 1/2 Burning Effect Setting of Endocut Mode or Conventional Endocut Mode Mitsuhiro Kida Introduction & Aim: After endoscopic sphincterotomy (EST) were developed by Kawai K, Classen M, and Sohma T, individually, endoscopic removal of bile duct stone and endoscopic retrograde billiary drainage for obstructive jaundice has been accepted as a standard treatment because of its less invasiveness etc. However 1-8% complication of bleeding after ESTwith conventional pure cutting current has been reported. Recently endocut mode of ERBE has been introduced in clinical fields and its usefulness such as easy cut without bleeding etc. has been reported. However pancreatitis due to its burning effect with endocut mode is feared. Then we conducted the randomized control in which the usefulness and complications of newly developed PSD (Olympus Co., Tokyo) with 1/2 burning effect setting of endocut mode on EST is investigated, compared with conventional endocut mode. Subjects & Methods: From April, 2004 up to now, a randomized control trial has been performed prospectively in 54 patients (M:FZ29:25, averaged age 67.2 y/o) who were consisted of 29 bile duct stone, 15 pancreas cancer, 3 cholangiocarcinoma, 2 bile duct cancer, and 5 others. These patients were assigned to receive EST by either PSD with 1/2 burning effect setting of endocut mode (PSD group: 28 pts) or conventional endocut mode (EC group: 26 pts). Then quality of cutting (smooth, hard, zipper, perforation) and complication such as bleeding and pancreatitis after ESTwere investigated in this study. Summary of Results: There was no significant difference on background such as, age, sex distribution, original diseases, and aim of procedure in both PSD and EC group. Smooth, hard, and zipper cut was occurred 27 (96%), 1 (4%), 0 in PSD group and 25 (96%), 1 (4%), 0 in EC group, respectively. And there was no perforation case in both groups. No bleeding, oozing, massive bleeding requiring hemostasis were recorded 26 (93%), 2 (7%), 0, in PSD group and 24 (92%), 2 (8%), 0 in EC group, respectively. And hyperamylasemia, mild pancreatitis, and severe pancreatitis (Cotton’s classification.) were occurred 21% (6/28), 7% (2/28) in PSD and 27% (7/26), 12% (3/26) in EC group, respectively. However there is no significant difference between PSD and EC group at the present. Conclusions: We concluded that EST by PSD with 1/2 burning effect setting of endocut mode were equal to EST by endocut mode (EC) on its performance and complications. Further investigations is needed to confirm these results.