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

Yosuke Kataoka; Yosuke Tsuji; Kingo Hirasawa; Kengo Takimoto; Tomonori Wada; Satoshi Mochizuki; Ken Ohata; Yoshiki Sakaguchi; Keiko Niimi; Satoshi Ono; Shinya Kodashima; Nobutake Yamamichi; Mitsuhiro Fujishiro; Kazuhiko Koike

doi:10.1055/a-0860-5280

Endoscopy, Table of Contents

Endoscopy 2019; 51(07): 619-627
DOI: 10.1055/a-0860-5280

Original article

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

Yosuke Kataoka

¹Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

,

Yosuke Tsuji

¹Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

,

Kingo Hirasawa

²Division of Endoscopy, Yokohama City University Medical Center, Kanagawa, Japan

,

Kengo Takimoto

³Department of Gastroenterology, Takeda General Hospital, Kyoto, Japan

⁴Department of Gastroenterology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan

,

Tomonori Wada

⁵Department of Gastroenterology, Sanraku Hospital, Tokyo, Japan

,

Satoshi Mochizuki

⁶Shinagawa Gut Clinic, Tokyo, Japan

,

Ken Ohata

⁷Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan

,

Yoshiki Sakaguchi

¹Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

,

Keiko Niimi

¹Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

⁸Center for Epidemiology and Preventive Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

,

Satoshi Ono

⁹Department of Gastroenterology, Chiba-Nishi General Hospital, Matsudo, Japan

,

Shinya Kodashima

¹⁰Department of Gastroenterology, Teikyo University School of Medicine, Tokyo, Japan

,

Nobutake Yamamichi

¹Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

,

Mitsuhiro Fujishiro

¹Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

¹¹Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

,

Kazuhiko Koike

¹Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

› Author Affiliations

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.

Full Text

References

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