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Steroid for stenosis after esophageal ESD

Steroid injection with oral administration in preventing stricture after endoscopic submucosal dissection for esophageal carcinoma. - Stellar Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031220557
Enrollment
30
Registered
2023-01-05
Start date
2023-01-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal carcinoma esophageal stricture

Interventions

After ESD for superficial esophageal cancer, combination therapy with local injection of triamcinolone and oral prednisolone is performed for an off-label purpose.
D014222,D011239
Steroid injection with oral administration

Sponsors

Kakushima Naomi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as esophageal carcinoma. 2. Depth up to cT1b(SM1, =1/2 circumference or simultaneous resection of multiple adjacent lesions which are expected to have ulcer with >3/4 circumference after ESD. 5. Patients who are indicated and scheduled for esophageal ESD. 6. ECOG performance status of 0 or1. 7. Age >= 18. 8. Patients who provide written informed consent. 9. Patients who can go to the outpatient clinic according to the clinical research schedule

Exclusion criteria

Exclusion criteria: 1. Diabetes Mellitus with HbA1c >=8%. 2. Severe liver, renal, cardiovascular disease. 3. Patients who are receiving continuous systemic administration of steroids or other immunosuppressants at the time of informed consent 4. Patients with infectious diseases that require systemic treatment. 5. Patients who have allergy to triamcinolone, prednisolone, and sulfamethoxazole trimethoprim. 6. Patients taking desmopressin acetate. 7. Patients who have active HBV hepatitis. 8. Patients who are pregnant. 9. Patients who the investigator judges inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Esophageal non-stenosis rate up to 12 weeks after ESD

Secondary

MeasureTime frame
1. Number of endoscopic dilations for esophageal stenosis up to 12 weeks after ESD. 2. Stenosis-free period after ESD. 3. Rate of adverse events

Contacts

Public ContactNaomi Kakushima

The University of Tokyo Hospital

n.kakushima@gmail.com+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026