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The first management using intubation of a nasogastric tube with Gastrografin enterography or long tube for non-strangulated acute small bowel obstruction: a multicenter, randomized controlled trial

  • Original Article–Alimentary Tract
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Abstract

Background

Gastrointestinal decompression is generally applied to a non-strangulated acute small bowel obstruction (NSASBO). Although long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G) have shown advantages over NGT alone in previous studies, no studies appear to have compared LT and NGT-G.

Methods

In this multicenter, randomized controlled trial, patients with NSASBO were randomly assigned to receive LT or NGT-G between July 2016 and November 2018 at 11 Japanese institutions. The primary endpoint was non-inferiority of NGT-G compared to LT for non-surgery rate, and the lower limit of the 95% confidence interval for the non-surgery rate (−15%) was set as the lower margin for inferiority of NGT-G compared to LT.

Results

In total, 223 patients (LT group, n = 111; NGT-G group, n = 112) were analyzed in the present trial. The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI − 5.55 to 12.91; non-inferiority P = 0.00002923). On the other hand, the non-surgery rate with pure NGT-G alone (76.8%) that represents non-cross-over NGT-G without subsequent LT was significantly lower than that with LT (P = 0.039). Median procedure time was significantly shorter with NGT-G (1 min) than with LT (25 min; P < 0.001), whereas no significant differences in mortality or hospital stay were noted between groups.

Conclusion

NGT-G is an effective alternative to LT as a first-line treatment for NSASBO. A sequential strategy comprising NGT-G followed by LT might offer a new standard for NSASBO.

Clinical trials registration

This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (umin.ac.jp/ctr Identifier: UMIN000022669) prior to the start of this trial.

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Acknowledgments

We are grateful to all physicians and institutions who participated in the present study. We also thank Yumi Yoshida (Division of Endoscopy, Nagoya City University Hospital) for creating a computer-aided randomization system, Takako Onodera (Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences) for data management of this clinical trial, and Dr. Satoshi Ohsaga (Clinical Research Management Center, Nagoya City University Hospital) for statistical design and analysis. This study was supported, in part, by multicenter collaborative clinical research funding from the Japanese Gastroenterological Association (to T. Shimura) that had no such involvement to this trial.

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Authors and Affiliations

  1. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan

    Takahito Katano, Takaya Shimura, Hirotada Nishie, Yu Nojiri, Yasuyuki Okamoto, Keiji Ozeki, Noriyuki Hayashi & Hiromi Kataoka

  2. Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan

    Tomohiro Iwai, Shunsuke Shibata, Sho Matoya, Yoshihito Nagura & Yuki Inagaki

  3. Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan

    Keisuke Itoh, Mika Kitagawa & Yoshito Tanaka

  4. Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute, 480-1195, Japan

    Masahide Ebi & Satoshi Ono

  5. Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan

    Yusuke Mizuno & Tomonori Yamada

  6. Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya, 468-8520, Japan

    Shozo Togawa & Miyuki Sugiura

  7. Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, 5-161 Maehata, Tajimi, 507-8522, Japan

    Takashi Mizushima

  8. Department of Gastroenterology, Gamagori City Hospital, 1-1 Mukaida, Hirata-cho, Gamagori, 443-8501, Japan

    Yusuke Inagaki

  9. Department of Gastroenterology, Chukyo Hospital, 1-1-10 Sanjyo, Minami-ku, Nagoya, 457-8510, Japan

    Hiroki Koguchi

  10. Department of Gastroenterology, Nagoya City West Medical Center, 1-1-1 Hirate, Kita-ku, Nagoya, 462-8508, Japan

    Satoshi Ono

  11. Department of Gastroenterological Surgery, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan

    Shuji Takiguchi

Authors
  1. Takahito Katano
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  2. Takaya Shimura
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  3. Hirotada Nishie
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Corresponding author

Correspondence to Takaya Shimura.

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Katano, T., Shimura, T., Nishie, H. et al. The first management using intubation of a nasogastric tube with Gastrografin enterography or long tube for non-strangulated acute small bowel obstruction: a multicenter, randomized controlled trial. J Gastroenterol 55, 858–867 (2020). https://doi.org/10.1007/s00535-020-01708-5

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  • DOI: https://doi.org/10.1007/s00535-020-01708-5

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