Refractory anastomotic stricture after surgical resection for esophageal cancer
Conditions
Interventions
A: EBD (endoscopic balloon dilation) followed by steroid (triamcinolone) injection to the dilated anastomotic stricture. Total amount of injected triamcinolone is 40mg/4ml.
B: RIC (Radical Incision a
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 st inclusion criteria 1) Meet all the following criteria about surgery for esophageal cancer: a) Subtotal esophagectomy for thoracic esophageal cancer performed. b) No finding of recurrence. c) Gastric tube reconstruction. d) No residual tumor. 2) Endoscopic balloon dilation (EBD) or bougienage for anastomotic stricture was performed more than twice for 24 weeks. If dilations were performed twice or more within 6 days , dilation was counted as once. 3) No prior history of endoscopic incision for anastomotic stricture. 4) Dysphagia score >=2. 5) Stricture length <=2cm diagnosed by endoscopy or X-ray fluoroscopy. 6) No postoperative chemotherapy for esophageal cancer within 28 days before registration. 7) No prior history of radiotherapy for recurrence after esophagectomy or preoperative radiotherapy more than 60 Gy. 8) No prior history of chemotherapy for any cancer within 28 days before registration. 9) No plan of chemotherapy within 24 weeks after registration. 10) Age>=20 11) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 12) Sufficient organ function 13) Written informed consent 2 nd inclusion criteria At any point after the last dilatation, the presence of anastomotic stricture was confirmed by endoscopic examination performed within 28 days before second registration. The presence of anastomotic stricture is defined as the situation that endoscope (diameter, 9.6 mm-10.4 mm) does not pass through the anastomotic stricture. Pinhole stricture which a device for dilatation or RIC cannot pass through is ineligible.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactIkuo Aoyama, MD
JCOG1207 Coordinating Office department of gastroenterology, Japanese Red Cross Otsu Hospital
Outcome results
None listed