Subjects

ABSTRACT

Objective

Endoscopic balloon dilation (EBD) is a standard treatment for anastomotic strictures after esophagectomy, and requires multiple dilations. We conducted a randomized controlled trial to assess the efficacy of adding a steroid injection to EBD to reduce restricture.

Methods

Patients were randomized to receive EBD combined with either triamcinolone or placebo injection. The primary endpoint was the number of dilations required to resolve the stricture. The secondary endpoints were restricture-free survival and adverse events. Patients with a dysphagia symptom score of ≥2 after esophagectomy with an endoscopy-confirmed anastomotic stricture were included. A total of 50 mg of triamcinolone acetonide (50 mg/5 mL) or an identical volume of normal saline solution as a placebo was injected per site using a 25-gauge needle immediately after EBD. Both the patient and treating physician were blinded to the treatment given.

Results

During the 4-year study period, 65 patients were randomized to either the steroid group (n = 33) or placebo group (n = 32). The median number of EBDs required to resolve strictures was 2.0 (interquartile range, 1.0–2.5) in the steroid group and 4.0 (interquartile range, 2.0–6.8) in the placebo group (p < 0.001). After 6 months of follow-up, 39% of patients who had received steroid injections remained recurrence free compared with 16% of those who had received saline injections (p = 0.002). No adverse events occurred during follow-up.

Conclusions

Steroid injection shows promising results for the prevention of stricture recurrence in patients who underwent EBD for anastomotic strictures.

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Acknowledgements

We thank Kelly Zammit, BVSc, from Edanz Group (www.edanzediting.com/ac), for editing a draft of this manuscript.

Author information

Affiliations

  1. Department of Gastroenterology, Osaka Red Cross Hospital, Osaka, Japan

    • Noboru Hanaoka MD
    •  & Takeshi Yamashina , MD
  2. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

    • Ryu Ishihara MD
    • , Yoji Takeuchi MD
    • , Noriya Uedo MD
    • , Noriko Matsuura MD
    • , Koji Higashino MD
    •  & Takashi Kanesaka MD
  3. Department of Surgery, Osaka General Medical Center, Osaka, Japan

    • Masaaki Motoori MD
  4. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Japan

    • Yoshito Hayashi MD
  5. Department of Gastroenterology, Osaka Rosai Hospital, Sakai, Japan

    • Takuya Yamada MD
  6. Department of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka, Japan

    • Tomofumi Akasaka MD
  7. Department of Surgery, Osaka International Cancer Institute, Osaka, Japan

    • Masahiko Yano MD
    • , Hiroshi Miyata MD
    •  & Keijiro Sugimura MD
  8. Department of Cancer Epidemiology and Prevention, Center for Cancer Control and Statistics, Osaka International Cancer Institute, Osaka, Japan

    • Yuri Ito PhD
  9. Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan

    • Kenta Hamada MD
    •  & Yasushi Yamasaki MD
  10. Department of Gastroenterology, Kaizuka City Hospital, Kaizuka, Japan

    • Kenji Aoi MD
  11. Department of Gastroenterology, Obihiro-Kosei General Hospital, Obihiro, Japan

    • Takashi Ito MD
  12. Department of Gastroenterology, Itami City Hospital, Itami, Japan

    • Hiroyasu Iishi MD

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Guarantor of the article

Noboru Hanaoka, MD.

Specific author contributions

NH and RI conceived and designed the study. MM, YT, NU, YT, TY, KH, TA, MY, HM, KS, KH, YY, NM, TK, KA, and TI provided study materials or patients. NH, NU, and YT analyzed and interpreted the data. NH drafted the article. HI critically revised the article for important intellectual content. YI performed the statistical analyses. NH acquired the funding. All authors were responsible for conducting the study, including care of the patients, acquisition of the data, and interpretation of the data after analysis. After drafting of the initial manuscript, all authors critically revised the manuscript and approved the final version.

Financial support

This study was supported by the Japanese Foundation for Research and Promotion of Endoscopy.

Potential competing interests

None.

Corresponding author

Correspondence to Noboru Hanaoka MD.

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DOI

https://doi.org/10.1038/s41395-018-0253-y