Early stage esophageal cancer after endoscopic submucosal dissection (ESD)
Conditions
Interventions
A: Local steroid (triamcinolone acetonide) injection to the ulcer immediately after ESD. Total amount of injected triamcinolone is 100 mg.
B: Oral steroid (predonisolone) administration two days afte
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven esophageal squamous cell carcinoma or basaloid cell carcinoma 2) Primary tumor located in the thoracic esophagus confirmed by endoscopy 3) Primary tumor located in the epithelium or lamina propria mucosa or muscularis mucosa confirmed by endoscopy 4) Neither lymph node metastases nor distant metastases in neck, chest and abdomen confirmed by computed tomography 5) Circumferential spread of the major lesion is 1/2 or more, but not entire circumference by endoscopy 6) Length of major lesion is 50 mm or less in longitudinal axis by endoscopy. 7) Circumferential spread 1/2 or less in all sub-lesions in patients with multiple lesions 8) Aged 20 to 85 years old 9) ECOG performance status of 0 to 1 10) No prior radiotherapy to the neck, chest wall, lung, or mediastinum 11) No prior surgery for esophagus or mediastinum 12) No prior treatment for esophageal cancer 13) Dysphagia score of 0 14) Adequate organ functions and HbA1c < 7.0% 15) Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| stricture-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMasaki Tanaka
JCOG1217Coordinating Office Endoscopy division, Shizuoka Cancer Cente
Outcome results
None listed