Steroid for stenosis after esophageal ESD

Phase 2

Recruiting

• Conditions: esophageal carcinoma; esophageal stricture; D000077277

• Registration Number: JPRN-jRCTs031220557
• Lead Sponsor: Kakushima Naomi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients diagnosed as esophageal carcinoma.
2. Depth up to cT1b(SM1, <200micrometers)
3. No metastasis confirmed by neck to abdominal CT.
4. Tumor with >=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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Esophageal non-stenosis rate up to 12 weeks after ESD

Secondary Outcome Measures

Name	Time	Method
1. Number of endoscopic dilations for esophageal stenosis up to 12 weeks after ESD.<br>2. Stenosis-free period after ESD.<br>3. Rate of adverse events