Insertability comparison of passive bending single-balloon prototype versus standard single-balloon enteroscopy: a multicenter randomized non-blinded trial

Naoki Hosoe; Kazuo Ohtsuka; Yutaka Endo; Makoto Naganuma; Noriyuki Ogata; Yuichiro Kuroki; Seiko Sasanuma; Kaoru Takabayashi; Shin-Ei Kudo; Hiroshi Takahashi; Haruhiko Ogata; Takanori Kanai

doi:10.1055/a-0650-4168

Endoscopy International Open, Table of Contents

CC BY-NC-ND 4.0 · Endosc Int Open 2018; 06(10): E1184-E1189
DOI: 10.1055/a-0650-4168

Original article

Insertability comparison of passive bending single-balloon prototype versus standard single-balloon enteroscopy: a multicenter randomized non-blinded trial

Naoki Hosoe

¹Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan

,

Kazuo Ohtsuka

²Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan

³Departments of Endoscopy, Tokyo Medical and Dental University, Tokyo, Japan apan

,

Yutaka Endo

⁴Center for Gastroenterology and Inflammatory Bowel Disease, Ofuna Chuo Hospital, Kamakura, Japan

,

Makoto Naganuma

⁵Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan

,

Noriyuki Ogata

²Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan

,

Yuichiro Kuroki

⁶Department of Gastroenterology, Fujigaoka Hospital, Showa University, Yokohama, Japan

,

Seiko Sasanuma

²Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan

,

Kaoru Takabayashi

¹Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan

,

Shin-Ei Kudo

²Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan

,

Hiroshi Takahashi

⁶Department of Gastroenterology, Fujigaoka Hospital, Showa University, Yokohama, Japan

,

Haruhiko Ogata

¹Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan

,

Takanori Kanai

⁵Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan

› Author Affiliations

Abstract

Background and study aims Traversing the ileocecal valve (ICV) is technically challenging with a retrograde approach to single-balloon enteroscopy (SBE). A novel technique called responsive insertion technology (RIT) colonoscopy was developed to obtain a higher cecal intubation rate in this setting. A prototype long SBE equipped with RIT (P-SBE) was developed to obtain superior insertability. The aim of this study was to compare the insertability of a standard single-balloon enteroscope (S-SBE) versus a P-SBE.

Patients and methods This study was a multicenter, randomized, non-blinded, trial of 62 patients with small bowel pathologies. All procedures were performed with SBE via the trans-anal route. Procedure success was defined as stable intubation of the terminal ileum (TI) 20 cm beyond the ICV. The primary variable was time to reach stable TI intubation 20 cm beyond the ICV (TSTII). If stable TI intubation was not achieved within 10 minutes, the initial SBE was removed through the indwelling overtube and replaced with another SBE.

Results Sixty patients were examined with two patients excluded from this study. TSTII using P-SBE was significantly decreased compared to S-SBE (mean P-SBE vs S-SBE: 98.3 vs 169.4 second, P = 0.006). The completion rates for stable intubation within 10 minutes of using P-SBE and S-SBE were 96.8 % and 86.2 %, respectively (P = 0.19). On endoscope replacement, all patients had achieved stable TI intubation.

Conclusions SBE with RIT improves insertability when traversing the ileocecal valve in retrograde SBE.

Full Text

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