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Endoscopy 2019; 51(07): 619-627
DOI: 10.1055/a-0860-5280
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial

Yosuke Kataoka
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Yosuke Tsuji
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Kingo Hirasawa
2   Division of Endoscopy, Yokohama City University Medical Center, Kanagawa, Japan
,
Kengo Takimoto
3   Department of Gastroenterology, Takeda General Hospital, Kyoto, Japan
4   Department of Gastroenterology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
,
Tomonori Wada
5   Department of Gastroenterology, Sanraku Hospital, Tokyo, Japan
,
Satoshi Mochizuki
6   Shinagawa Gut Clinic, Tokyo, Japan
,
Ken Ohata
7   Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan
,
Yoshiki Sakaguchi
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Keiko Niimi
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
8   Center for Epidemiology and Preventive Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Satoshi Ono
9   Department of Gastroenterology, Chiba-Nishi General Hospital, Matsudo, Japan
,
Shinya Kodashima
10   Department of Gastroenterology, Teikyo University School of Medicine, Tokyo, Japan
,
Nobutake Yamamichi
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Mitsuhiro Fujishiro
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
11   Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Kazuhiko Koike
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
› Author AffiliationsTRIAL REGISTRATION: prospective multicenter randomized controlled trial UMIN000015091 at http://www.umin.ac.jp
Further Information

Publication History

submitted 10 September 2018

accepted after revision 04 February 2019

Publication Date:
12 March 2019 (online)

Also available at
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See also:

Disputes about the efficacy of polyglycolic acid shielding for prevention of bleeding after endoscopic submucosal dissectionEndoscopy 2019; 51(12): 1183-1183
DOI: 10.1055/a-0999-5452

See also:

Reply to Wang et al.Endoscopy 2019; 51(12): 1184-1184
DOI: 10.1055/a-1013-4254

See also:

Do polyglycolic acid sheets really prevent bleeding after endoscopic submucosal dissection? An opinion from physiological viewpointsEndoscopy 2020; 52(01): 76-76
DOI: 10.1055/a-1021-8624

See also:

Reply to Murakami et al.Endoscopy 2020; 52(01): 77-77
DOI: 10.1055/a-1026-6136

Abstract

Background Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Recent reports have described the efficacy of the endoscopic shielding method with polyglycolic acid (PGA) sheets and fibrin glue for the prevention of adverse events after ESD. The aim of the present study was to investigate whether the PGA shielding method provides additional benefit in preventing post-ESD bleeding compared with standard care.

Methods This was a prospective, multicenter, randomized controlled trial. Patients at high risk of post-ESD bleeding were enrolled in the study. Before ESD, patients were randomized to either the PGA group or the control group. After completing ESD in the PGA group, PGA sheets were placed onto the ulcer floor and adhered with fibrin glue. The primary end point was the post-ESD bleeding rate.

Results 140 eligible patients were enrolled from September 2014 to September 2016, and 137 were included in the intention-to-treat analysis (67 in the PGA group and 70 in the control group). Post-ESD bleeding occurred in three patients (4.5 %) in the PGA group and in four patients (5.7 %) in the control group; there was no significant difference between the two groups (P > 0.99). Post-ESD bleeding tended to occur later in the control group than in the PGA group (median 12.5 days [range 8 – 14] vs. 2 days [range 0 – 7], respectively).

Conclusion The PGA shielding method did not demonstrate a significant effect on the prevention of post-ESD bleeding.

 

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