A randomized controlled phase II/III study comparing EBD combined with steroid to RIC combined with steroid for refractory anastomotic stricture after esophagectomy (JCOG1207: RICS study)
Phase 2
Recruiting
- Conditions
- Refractory anastomotic stricture after surgical resection for esophageal cancer
- Registration Number
- JPRN-UMIN000014017
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
1) Active infection requiring systemic therapy 2) Body temperature >=38 degrees Celsius 3) Pregnancy, possible pregnancy within 28 days after delivery or breastfeeding 4) Psychiatric disease 5) Patients requiring systemic steroid medication 6) Patients requiring continuous anticoagulant or antiplatelet drug 7) Poorly controlled hypertension 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II: Proportion of Grade 3/4 intraoperative hemorrhage, esophageal perforation or hemorrhage, pneumothorax, lung or mediastinum infection, or other unexpected adverse reactions. Phase III: Restenosis-free survival; Number of dilation for 24 weeks after treatment
- Secondary Outcome Measures
Name Time Method Phase II/III: Proportion of patients with anastomotic diameter > 10 mm at the time of 8 weeks after treatment; Proportion of adverse events; Proportion of patients experiencing improvement of dysphagia score at the time of 2, 4, 8, 24 weeks after treatment; Proportion of patients with dysphagia score <= 1 at the time of 24 weeks after treatment.