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) - 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)

Japan Clinical Oncology Group (JCOG)0 sites360 target enrollmentSeptember 5, 2014

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Early stage esophageal cancer after endoscopic submucosal dissection (ESD)
Sponsor: Japan Clinical Oncology Group (JCOG)
Enrollment: 360
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

September 5, 2014

End Date

September 5, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Japan Clinical Oncology Group (JCOG)

•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