A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study - 15/01/12

Doi : 10.1016/j.gie.2011.10.012

Hiroshi Kawakami, MD, PhD ^1,^⁎, Hiroyuki Maguchi, MD, PhD ², Tsuyoshi Mukai, MD, PhD ³, Tsuyoshi Hayashi, MD, PhD ⁴, Tamito Sasaki, MD, PhD ⁵, Hiroyuki Isayama, MD, PhD ⁶, Yousuke Nakai, MD, PhD ⁶, Ichiro Yasuda, MD, PhD ⁷, Atsushi Irisawa, MD, PhD ⁸, Teitetsu Niido, MD, PhD ⁹, Yoshinobu Okabe, MD, PhD ¹⁰, Shomei Ryozawa, MD, PhD ¹¹, Takao Itoi, MD, PhD ¹², Keiji Hanada, MD, PhD ¹³, Masataka Kikuyama, MD, PhD ¹⁴, Yoshifumi Arisaka, MD, PhD ¹⁵, Shogo Kikuchi, MD, PhD ¹⁶
Japan Bile Duct Cannulation Study Group
¹ Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo, Japan
² Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan
³ Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan
⁴ Department of 4th Internal Medicine, Sapporo Medical University School of Medicine, Sapporo, Japan
⁵ Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan
⁶ Department of Gastroenterology, The University of Tokyo, Tokyo, Japan
⁷ First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan
⁸ Department of Gastroenterology and Rheumatology, Fukushima Medical University School of Medicine, Fukushima, Japan
⁹ Department of Gastroenterology, Toda Chuo General Hospital, Toda, Japan
¹⁰ Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
¹¹ Department of Gastroenterology and Hepatology, Yamaguchi University Hospital, Yamaguchi, Japan
¹² Department of Gastroenterology and Hepatology, Tokyo Medical University Hospital, Tokyo, Japan
¹³ Center of Endoscopy, Onomichi General Hospital, Onomichi, Japan
¹⁴ Department of Gastroenterology, Shizuoka General Hospital, Shizuoka, Japan
¹⁵ Second Department of Internal Medicine, Osaka Medical College Hospital, Osaka, Japan
¹⁶ Department of Public Health, Aichi Medical University School of Medicine, Aichi, Japan

Reprint requests: Hiroshi Kawakami, MD, PhD, Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan

Riassunto

Background

Wire-guided cannulation (WGC) with a sphincterotome (S) 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 multiendoscopist study.

Design

A prospective, multicenter RCT with a 2 × 2 factorial design.

Setting

Fifteen referral endoscopy units.

Patients

In total, 400 consecutive patients with naive papillae who were candidates for ERCP were enrolled and randomized.

Interventions

Patients were assigned to 4 groups according to combined catheter (S or catheter [C]) and method (with/without guidewire [GW]).

Main Outcome Measurements

Success rate of SBDC performed in 10 minutes, SBDC time, fluoroscopy time, and incidence of complications.

Results

There was no significant difference in the SBDC success rate between the groups with and without GW, between C and S, or among 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 minutes or less (P = .036 and .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 fluoroscopy 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. (Clinical trial registration number: UMIN000002572.)

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Abbreviations : BD, BOAD, C, GW, ITT, PEP, RCT, S, SBDC, PP, WGC

Mappa

DISCLOSURE: The authors disclosed no financial relationships relevant to this publication. This study was supported by a Japanese Foundation for Research and Promotion of Endoscopy grant (H.K.).

Esportazione

Vol 75 - N° 2

P. 362 - febbraio 2012 Ritorno al numero

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