A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study
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概要
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Background: Wire-guided cannulation (WGC) with a sphincterotome for selective bile duct cannulation (SBDC) has been reported to have a higher success rate and lower incidence of post-ERCP pancreatitis (PEP) than conventional methods in some randomized controlled trials (RCTs) that were both single-center and limited to only a few endoscopists. Objective: To estimate the difference in SBDC according to the method and catheter used in a multicenter and multi-endoscopist study. Design: A prospective multicenter RCT with a 2-by-2 factorial design. Setting: Fifteen referral endoscopy units. Patients: In total, 400 consecutive patients with naïve papilla who were candidates for ERCP were enrolled and randomized. Interventions: Patients were assigned to 4 groups according to combined catheter (sphincterotome (S) or catheter (C)) and method (with/without guidewire (GW)). Main Outcome Measurements: Success rate of SBDC in 10 min, time for SBDC, fluoroscopic time and incidence of complications. Results: There was no significant difference in SBDC success rate between with- and without-GW, between C and S, or between the 4 groups (C+GW, C, S+GW, S). WGC had a tendency to significantly shorten cannulation and fluoroscopy times only in approximately 70% of patients in this study in whom SBDC was achieved in 10 min or less (P = 0.036 and 0.00004, respectively). All 4 groups resulted in similar outcomes in PEP (4%, 5.9%, 2%, and 2.1%, respectively). Limitations: Non double-blind study. Conclusions: WGC appears to significantly shorten cannulation and fluoroscopic times. However, neither the method nor type of catheter used resulted in significant differences in either SBDC success rate or incidence of PEP in this RCT.
著者
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KUWATANI MASAKI
Department of Gastroenterology, Hokkaido University Graduate School of Medicine
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Hayashi Tsuyoshi
Fourth Department Of Internal Medicine Sapporo Medical University School Of Medicine
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Yasuda I
Gifu Univ. School Of Medicine Gifu Jpn
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Mukai Tsuyoshi
Department Of Gastroenterology Gifu Municipal Hospital
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Yasuda Ichiro
岐阜大学 医学系研究科第一内科
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Yasuda I
First Department Of Internal Medicine Gifu University School Of Medicine
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Hayashi Tsuyoshi
Department Of 4th Internal Medicine Sapporo Medical University School Of Medicine
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Sasaki Tsuneo
Department Of Chemotherapy Tokyo Metropolitan Komagome Hospital
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Kanamori Hiroe
Department Of Gastroenterology And Hematology Hokkaido University Graduate School Of Medicine
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Itoi Takao
4th Department Of Internal Medicine Tokyo Medical University
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Hanada Keiji
Center Of Gastroenterology Onomichi General Hospital
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Kobayashi Hajime
Fourth Department Of Internal Medicine Obihiro Kosei Hospital
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Sasaki Takamitsu
Department Of Surgery Fukuoka University
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Kuwatani Masaki
Department Of Gastroenterology Hokkaido University Graduate School Of Medicine
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Ikeda Takahisa
Department Of Gastroenterology And Hepatology Tokyo Medical University
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Kawakami Hiroshi
北海道大学 医学研究科消化器内科
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Kawakami Hiroshi
Department Of Gastroenterology And Hepatology Hokkaido University
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