Evidence map›Paper›PMID 42313516›Full record

Trial reportDigestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society2026

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).

Masaki Tanaka, Hiroyuki Ono, Kohei Takizawa, Shintaro Iwamoto, Yusuke Sano, Seiichiro Abe, Tomohiro Kadota, Takuya Wada, Akiyoshi Ishiyama, Hiroyoshi Nakanishi and 5 more

Abstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. After JCOG1217: Toward Risk-Adapted Steroid Prophylaxis for Post-ESD Esophageal Strictures.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Masaki TanakaDivision of Endoscopy, Shimane Prefectural Central Hospital, Izumo, Shimane, Japan.
Hiroyuki OnoDivision of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
Kohei TakizawaDivision of Gastroenterology, Kanagawa Cancer Center, Yokohama, Kanagawa, Japan.
Shintaro IwamotoJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Yusuke SanoJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Seiichiro AbeEndoscopy Division, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-2736-6921
Tomohiro KadotaDepartment of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.ORCID https://orcid.org/0000-0002-0408-3494
Takuya WadaDepartment of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Akiyoshi IshiyamaDepartment of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Hiroyoshi NakanishiDepartment of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.
Shinji NagataDepartment of Gastroenterology, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan.
Haruhiko FukudaJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Manabu MutoDepartment of Medical Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Tomonori YanoDepartment of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
Gastrointestinal Endoscopy Study Group of the Japan Clinical Oncology Group

Funding

National Cancer Center Research and Development Fund 2020-J-3National Cancer Center Research and Development Fund 2023-J-03National Cancer Center Research and Development Fund 2026-J-03National Cancer Center Research and Development Fund 23-A-16National Cancer Center Research and Development Fund 23-A-19National Cancer Center Research and Development Fund 26-A-4National Cancer Center Research and Development Fund 29-A-3
6 · The paper itself

Abstract

objectivesEndoscopic 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.

methodsThis 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).

resultsA 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.

conclusionsWhile oral prednisolone administration and local triamcinolone injection demonstrated comparable outcomes, oral prednisolone did not demonstrate superiority for ES prevention after extensive esophageal ESD.

Indexed as

Endoscopic Mucosal ResectionEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaEsophageal StenosisPostoperative ComplicationsPrednisoloneTriamcinoloneAdministration, OralAgedAnti-Inflammatory AgentsFemaleGlucocorticoidsHumansInjectionsInjections, IntralesionalMaleAnti-Inflammatory AgentsGlucocorticoidsPrednisoloneTriamcinoloneendoscopic submucosal dissectionesophageal stricturepreventionrandomized controlled trial

Identifiers

PMID42313516
PMCPMC13277963

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.