JCOG1207: A randomized controlled phase II/III study comparing EBD combined with steroid versus RIC combined with steroid for refractory anastomotic stricture after esophagectomy

JRCT ID: jRCTs031180177

Registered date:05/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Refractory anastomotic stricture after surgical resection for esophageal cancer
• Date of first enrollment: 01/07/2014
• Target sample size: 130
• Study type: Interventional

Intervention(s)

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 and Cutting) followed by steroid (triamcinolone) injection to the dilated anastomotic stricture. Total amount of injected triamcinolone is 40mg/4ml.

Outcome(s)

• Primary Outcome: 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: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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) Dysphagia score >=2.
4) Stricture length <=2cm diagnosed by endoscopy or X-ray fluoroscopy.
5) No postoperative chemotherapy for esophageal cancer within 28 days before registration.
6) No prior history of radiotherapy for recurrence after esophagectomy or preoperative radiotherapy more than 60 Gy.
7) No prior history of chemotherapy for any cancer within 28 days before registration, and
no plan of chemotherapy within 24 weeks after registration.
8) Age>=20
9) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
10) Sufficient organ function
11) Written informed consent

2 nd inclusion criteria
i) At any point after the last dilatation, the presence of anastomotic stricture was confirmed by endoscopic examination performed within 28 days before second registration.
ii) 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.

Exclude 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

Related Information

• Primary Sponsor: MUTO Manabu
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000014017