A Randomized Controlled Phase 3 Trial of Oral Prednisolone Administration Versus Local Triamcinolone Injection Therapy for Esophageal Stricture Prevention After Extensive Endoscopic Submucosal Dissection (JCOG1217).

Authors

Masaki Tanaka, Hiroyuki Ono, Kohei Takizawa, Shintaro Iwamoto, Yusuke Sano, Seiichiro Abe, Tomohiro Kadota, Takuya Wada, Akiyoshi Ishiyama, Hiroyoshi Nakanishi, Shinji Nagata, Haruhiko Fukuda, Manabu Muto, Tomonori Yano, Gastrointestinal Endoscopy Study Group of the Japan Clinical Oncology Group

Published in

Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society. Volume 38. Issue 6. Pages e70195.

Abstract

Endoscopic local triamcinolone injection is a standard therapy for esophageal stricture (ES) prevention after extensive endoscopic submucosal dissection (ESD); however, oral prednisolone administration is a promising alternative. This trial aimed to investigate the superiority of oral prednisolone administration to local triamcinolone injection for ES prevention after extensive ESD.
This phase 3, open-label, multicenter, randomized controlled trial enrolled patients with extensive superficial esophageal squamous cell carcinoma. The primary endpoint was stricture-free survival (SFS). Secondary endpoints were the number of endoscopic balloon dilations (EBDs) for 12 weeks after ESD, dysphagia score ≤ 1 at 12 weeks after ESD, and adverse events (AEs).
A total of 281 patients from 45 institutions were enrolled. The 12-week SFS rates were 88.5% (95% confidence interval [CI]: 81.6-92.9) and 94.8% (95% CI: 89.4-97.5) in the triamcinolone and prednisolone arms, respectively (hazard ratio 0.672, 90% CI [0.361-1.250], p = 0.14). Thirty-eight and 26 EBDs were performed for 14 and 10 patients, respectively, in the triamcinolone and prednisolone arms within 12 weeks after ESD. In the triamcinolone and prednisolone arms, 73.8% (95% CI: 65.7-80.8) and 80.7% (95% CI: 73.2-86.9) of patients, respectively, had dysphagia scores ≤ 1 at 12 weeks after ESD (p = 0.20). Grade 3/4 AEs occurred in 12 (8.7%) and 9 patients (6.7%) in the triamcinolone and prednisolone arms, respectively.
While oral prednisolone administration and local triamcinolone injection demonstrated comparable outcomes, oral prednisolone did not demonstrate superiority for ES prevention after extensive esophageal ESD.

PMID:
42313516
Bibliographic data and abstract were imported from PubMed on 19 Jun 2026.

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