Efficacy of Endoscopic Balloon Dilation for Small Bowel Strictures in Patients With Crohn's Disease: A Nationwide, Multi-centre, Open-label, Prospective Cohort Study

Fumihito Hirai, Akira Andoh, Fumiaki Ueno, Kenji Watanabe, Naoki Ohmiya, Hiroshi Nakase, Shingo Kato, Motohiro Esaki, Yutaka Endo, Hironori Yamamoto, Toshiyuki Matsui, Mitsuo Iida, Toshifumi Hibi, Mamoru Watanabe, Yasuo Suzuki, Takayuki Matsumoto

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background and Aims: Endoscopic balloon dilation [EBD] is an alternative to surgery for Crohn's strictures. However, there have been no prospective studies of EBD for small bowel strictures in patients with Crohn's disease [CD]. The aim of this study was to clarify the efficacy and safety of EBD using balloon-assisted enteroscopy for small bowel strictures in CD.

Methods: This was a nationwide, multi-centre, open-label, prospective cohort study. The subjects were CD patients with at least one symptom [abdominal pain, abdominal bloating, nausea] attributable to small bowel stricture. The primary endpoint related to short-term outcomes was the level of improvement of symptoms evaluated using a 10-cm visual analogue scale [VAS]. Cases in which VAS scores for all symptoms improved 4 weeks after EBD compared with baseline were considered to have short-term symptomatic improvement. Factors related to short-term treatment outcomes and safety were investigated as secondary endpoints.

Results: A total of 112 patients were enrolled. Seventeen were later excluded because they did not meet the criteria, and the analysis was conducted with the remaining 95 patients. Of these 95 patients, procedure failure occurred in six [6.3%], and short-term symptomatic improvement was achieved in 66 patients [69.5%]. Adverse events were seen in five patients [5%] and all of these improved with conservative treatment. A large dilation diameter of the balloon was a factor contributing to the success of EBD.

Conclusions: EBD using balloon-assisted enteroscopy for small bowel strictures in CD patients was shown to be an effective and safe procedure.

Clinical trial registry: UMIN000005946.

Original languageEnglish
Pages (from-to)394-401
Number of pages8
JournalJournal of Crohn's & colitis
Volume12
Issue number4
DOIs
Publication statusPublished - 28-03-2018

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Crohn Disease
Dilatation
Pathologic Constriction
Cohort Studies
Prospective Studies
Visual Analog Scale
Safety
Nausea
Abdominal Pain
Registries
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

Hirai, Fumihito ; Andoh, Akira ; Ueno, Fumiaki ; Watanabe, Kenji ; Ohmiya, Naoki ; Nakase, Hiroshi ; Kato, Shingo ; Esaki, Motohiro ; Endo, Yutaka ; Yamamoto, Hironori ; Matsui, Toshiyuki ; Iida, Mitsuo ; Hibi, Toshifumi ; Watanabe, Mamoru ; Suzuki, Yasuo ; Matsumoto, Takayuki. / Efficacy of Endoscopic Balloon Dilation for Small Bowel Strictures in Patients With Crohn's Disease : A Nationwide, Multi-centre, Open-label, Prospective Cohort Study. In: Journal of Crohn's & colitis. 2018 ; Vol. 12, No. 4. pp. 394-401.
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abstract = "Background and Aims: Endoscopic balloon dilation [EBD] is an alternative to surgery for Crohn's strictures. However, there have been no prospective studies of EBD for small bowel strictures in patients with Crohn's disease [CD]. The aim of this study was to clarify the efficacy and safety of EBD using balloon-assisted enteroscopy for small bowel strictures in CD.Methods: This was a nationwide, multi-centre, open-label, prospective cohort study. The subjects were CD patients with at least one symptom [abdominal pain, abdominal bloating, nausea] attributable to small bowel stricture. The primary endpoint related to short-term outcomes was the level of improvement of symptoms evaluated using a 10-cm visual analogue scale [VAS]. Cases in which VAS scores for all symptoms improved 4 weeks after EBD compared with baseline were considered to have short-term symptomatic improvement. Factors related to short-term treatment outcomes and safety were investigated as secondary endpoints.Results: A total of 112 patients were enrolled. Seventeen were later excluded because they did not meet the criteria, and the analysis was conducted with the remaining 95 patients. Of these 95 patients, procedure failure occurred in six [6.3{\%}], and short-term symptomatic improvement was achieved in 66 patients [69.5{\%}]. Adverse events were seen in five patients [5{\%}] and all of these improved with conservative treatment. A large dilation diameter of the balloon was a factor contributing to the success of EBD.Conclusions: EBD using balloon-assisted enteroscopy for small bowel strictures in CD patients was shown to be an effective and safe procedure.Clinical trial registry: UMIN000005946.",
author = "Fumihito Hirai and Akira Andoh and Fumiaki Ueno and Kenji Watanabe and Naoki Ohmiya and Hiroshi Nakase and Shingo Kato and Motohiro Esaki and Yutaka Endo and Hironori Yamamoto and Toshiyuki Matsui and Mitsuo Iida and Toshifumi Hibi and Mamoru Watanabe and Yasuo Suzuki and Takayuki Matsumoto",
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Hirai, F, Andoh, A, Ueno, F, Watanabe, K, Ohmiya, N, Nakase, H, Kato, S, Esaki, M, Endo, Y, Yamamoto, H, Matsui, T, Iida, M, Hibi, T, Watanabe, M, Suzuki, Y & Matsumoto, T 2018, 'Efficacy of Endoscopic Balloon Dilation for Small Bowel Strictures in Patients With Crohn's Disease: A Nationwide, Multi-centre, Open-label, Prospective Cohort Study', Journal of Crohn's & colitis, vol. 12, no. 4, pp. 394-401. https://doi.org/10.1093/ecco-jcc/jjx159

Efficacy of Endoscopic Balloon Dilation for Small Bowel Strictures in Patients With Crohn's Disease : A Nationwide, Multi-centre, Open-label, Prospective Cohort Study. / Hirai, Fumihito; Andoh, Akira; Ueno, Fumiaki; Watanabe, Kenji; Ohmiya, Naoki; Nakase, Hiroshi; Kato, Shingo; Esaki, Motohiro; Endo, Yutaka; Yamamoto, Hironori; Matsui, Toshiyuki; Iida, Mitsuo; Hibi, Toshifumi; Watanabe, Mamoru; Suzuki, Yasuo; Matsumoto, Takayuki.

In: Journal of Crohn's & colitis, Vol. 12, No. 4, 28.03.2018, p. 394-401.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of Endoscopic Balloon Dilation for Small Bowel Strictures in Patients With Crohn's Disease

T2 - A Nationwide, Multi-centre, Open-label, Prospective Cohort Study

AU - Hirai, Fumihito

AU - Andoh, Akira

AU - Ueno, Fumiaki

AU - Watanabe, Kenji

AU - Ohmiya, Naoki

AU - Nakase, Hiroshi

AU - Kato, Shingo

AU - Esaki, Motohiro

AU - Endo, Yutaka

AU - Yamamoto, Hironori

AU - Matsui, Toshiyuki

AU - Iida, Mitsuo

AU - Hibi, Toshifumi

AU - Watanabe, Mamoru

AU - Suzuki, Yasuo

AU - Matsumoto, Takayuki

PY - 2018/3/28

Y1 - 2018/3/28

N2 - Background and Aims: Endoscopic balloon dilation [EBD] is an alternative to surgery for Crohn's strictures. However, there have been no prospective studies of EBD for small bowel strictures in patients with Crohn's disease [CD]. The aim of this study was to clarify the efficacy and safety of EBD using balloon-assisted enteroscopy for small bowel strictures in CD.Methods: This was a nationwide, multi-centre, open-label, prospective cohort study. The subjects were CD patients with at least one symptom [abdominal pain, abdominal bloating, nausea] attributable to small bowel stricture. The primary endpoint related to short-term outcomes was the level of improvement of symptoms evaluated using a 10-cm visual analogue scale [VAS]. Cases in which VAS scores for all symptoms improved 4 weeks after EBD compared with baseline were considered to have short-term symptomatic improvement. Factors related to short-term treatment outcomes and safety were investigated as secondary endpoints.Results: A total of 112 patients were enrolled. Seventeen were later excluded because they did not meet the criteria, and the analysis was conducted with the remaining 95 patients. Of these 95 patients, procedure failure occurred in six [6.3%], and short-term symptomatic improvement was achieved in 66 patients [69.5%]. Adverse events were seen in five patients [5%] and all of these improved with conservative treatment. A large dilation diameter of the balloon was a factor contributing to the success of EBD.Conclusions: EBD using balloon-assisted enteroscopy for small bowel strictures in CD patients was shown to be an effective and safe procedure.Clinical trial registry: UMIN000005946.

AB - Background and Aims: Endoscopic balloon dilation [EBD] is an alternative to surgery for Crohn's strictures. However, there have been no prospective studies of EBD for small bowel strictures in patients with Crohn's disease [CD]. The aim of this study was to clarify the efficacy and safety of EBD using balloon-assisted enteroscopy for small bowel strictures in CD.Methods: This was a nationwide, multi-centre, open-label, prospective cohort study. The subjects were CD patients with at least one symptom [abdominal pain, abdominal bloating, nausea] attributable to small bowel stricture. The primary endpoint related to short-term outcomes was the level of improvement of symptoms evaluated using a 10-cm visual analogue scale [VAS]. Cases in which VAS scores for all symptoms improved 4 weeks after EBD compared with baseline were considered to have short-term symptomatic improvement. Factors related to short-term treatment outcomes and safety were investigated as secondary endpoints.Results: A total of 112 patients were enrolled. Seventeen were later excluded because they did not meet the criteria, and the analysis was conducted with the remaining 95 patients. Of these 95 patients, procedure failure occurred in six [6.3%], and short-term symptomatic improvement was achieved in 66 patients [69.5%]. Adverse events were seen in five patients [5%] and all of these improved with conservative treatment. A large dilation diameter of the balloon was a factor contributing to the success of EBD.Conclusions: EBD using balloon-assisted enteroscopy for small bowel strictures in CD patients was shown to be an effective and safe procedure.Clinical trial registry: UMIN000005946.

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