Can a simple steroid injection prevent a painful complication of esophageal surgery?
NCT ID NCT04498260
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
After endoscopic removal of large, early-stage esophageal tumors, the esophagus can narrow and make swallowing difficult. This trial tests whether injecting a steroid directly into the surgical site works better than taking oral steroids to prevent that narrowing. About 30 people who have had extensive endoscopic resections will be randomly assigned to one of the two steroid approaches, and doctors will track how many develop strictures and how many dilation procedures are needed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- triamcinolone acetonide (injected steroid) or prednisolone (oral steroid)
- What this could lead to
- If one method works better, it could become the standard way to prevent painful narrowing of the esophagus after endoscopic surgery.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. Steroids carry risks like infection and high blood sugar.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
30 people
The number who actually took part.
- Started
-
Jan 2019
- Finished
-
May 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with a diagnosis of superficial esophageal neoplasm submitted to submucosal endoscopic resection greater than 3/4 of the organ circumference; * Absence of lymph node or distant metastases, evaluated through echoendoscopy, CT and PET-CT; * Signed informed consent form Exclusion Criteria: * Presence of invasive esophageal neoplasia * Hepatical cirrhosis * Diabetes mellitus with fasting glycemia above 200mg% * Use of corticosteroids in the 30 days prior to ESD * INR\> 1.5 * Platelet count less than 50,000 * Active gastrointestinal ulcer * Severe psychiatric illness * Glaucoma * History of allergy or hypersensitivity to corticosteroids or proton pump inhibitor
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, 01246-000, Brazil
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