A phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection(JCOG1217, Steroid EESD P3)
- Conditions
- Early stage esophageal cancer after endoscopic submucosal dissection (ESD)
- Registration Number
- JPRN-UMIN000015064
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 360
Not provided
1) Synchronous or metachronous (within 1 years) malignancies 2) Active infection requiring systemic therapy 3) Body temperature >=38 degrees Celsius 4) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding 5) Severe psychiatric disease 6) Patients requiring systemic steroid medication 7) Uncontrollable diabetes mellitus 8) Patients requiring continuous anticoagulant or antiplatelet drug 9) Poorly controlled hypertension 10) Histody of unstable angina within 3 weeks or myocardial infarction within 6 months 11) Patients with respiratory disease requiring continuous supplemental oxygen 12) Active gastroduodenal ulcer 13) Glaucoma, posterior capsule opacification or herpetic keratitis 14) History of surgery within 3 months 15) Positive HBs antigen, HBs antibody or HBc antibody 16) Allergy to Iodine 17) Hypersensitivity for triamcinolone acetonide, prednisolone, and proton pump inhibitor 18) Glucose-6-phosphate dehydrogenase deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method stricture-free survival
- Secondary Outcome Measures
Name Time Method the number of endoscopic balloon dilation for 12 weeks after ESD, adverse events, serious adverse events, and proportion of patients with dysphagia score =< 1 at the time of 12 weeks after ESD