JCOG2215: A randomized controlled phase III trial comparing endoscopic balloon dilation alone versus endoscopic balloon dilation with local triamcinolone injection for esophageal stricture after endoscopic submucosal dissection for esophageal cancer

JRCT ID: jRCTs031230645

Registered date:19/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal stricture after endoscopic submucosal dissection for esophageal cancer
• Date of first enrollment: 19/02/2024
• Target sample size: 260
• Study type: Interventional

Intervention(s)

Arm A: Endoscopic balloon dilation for the post-ESD esophageal stricture.
Arm B: Endoscopic balloon dilation combined with local triamcinolone injection of 40 mg/4 mL at the margin of laceration caused by EBD for the post-ESD esophageal stricture.

Outcome(s)

• Primary Outcome: Time to post-ESD esophageal stricture resolution
• Secondary Outcome: Proportion of patients who required rescue EBD, Number of endoscopic balloon dilation for 24 weeks, proportion of patients with dysphagia score 0 at the time of 24 weeks after treatment, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1st inclusion criteria
(1) Meet all the following about endoscopic submucosal dissection (ESD) for esophageal cancer:
(a) Meet either of the following.
(i) For a single lesion:
non-circumferential lesion measuring 8 cm or less in the longitudinal axis, or circumferential lesion measuring 5 cm or less in the longitudinal axis
(ii) For synchronous multiple lesions:
all lesions are non-circumferential and the entire lesion has a longitudinal axis of 8 cm or less, or either lesion is circumferential and the entire lesion has a longitudinal axis of 5 cm or less.
(b) En bloc resection and no macroscopic residual tumor.
(c) Histologically proven squamous cell carcinoma or basaloid carcinoma.
(d) Histologically diagnosed pT1a, Ly0, V0 and pVM0.
(2) No rule on whether and how to prevent post-ESD stricture.
(3) Dysphagia score >=1.
(4) Meet either of the following criteria in terms of endoscopic balloon dilation (EBD) for post-ESD stricture
(a)No prior dilation therapy
(b) Only one EBD alone and the period between that EBD and the secondary enrollment can be at least 14 days (the same day of the week two weeks later is acceptable).
(5) Age >=18
(6) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
(7) No prior treatment for esophageal cancer other than endoscopic resection
(8) No history of metachronous multiple esophageal cancers unless all of the following are met.
(a) Prior endoscopic resection
(b) No macroscopic residual tumor.
(c) Histologically proven squamous cell carcinoma or basaloid carcinoma.
(d) Histologically diagnosed pT1a, Ly0, V0 and pVM0.
(e) No post esophageal ESD stricture with scarring confirmed by a surveillance endoscopy, or a resolved post ESD esophageal stricture confirmed by a follow up endoscopy 4 weeks or later after dilation therapies.
(9) No history of head and neck cancer unless all of the following are met.
(a) No evidence of recurrence.
(b) No post ESD stricture with scarring confirmed by a surveillance endoscopy, or a resolved post ESD esophageal stricture confirmed by a follow up endoscopy 4 weeks or later after dilation therapies
(10) No prior chemotherapy for any cancer within 28 days before registration, and no plan of chemotherapy within 24 weeks after registration.
(11) No prior radiotherapy to the neck, chest wall, lung, or mediastinum
(12) Sufficient organ function
(a) White blood cell count >=2,000/mm3 and <=12,000/mm3.
(b) Hemoglobin >=8.0 g/dL.
(c) Platelet >=100,000/mm3.
(d) Total bilirubin <=2.0 mg/dL.
(e) Aspartate aminotransferase <=150 U/L.
(f) Alanine aminotransferase <=150 U/L.
(g) Creatinine <=2.0 mg/dL.
(13) Written informed consent

2nd inclusion criteria
(1) Within 28 days from the first registration.
(2) No treatment for post-ESD stricture has been done since the first registration.
(3) If a patient has received a single dose of EBD for post-ESD esophageal stricture before the first registration, it has been more than 14 days since the EBD.
(4) All of the following are met with the latest follow-up endoscopy performed within 28 days before the second registration.
(a) There is a post-ESD stricture in the thoracic esophagus that the endoscope (9.8-9.9 mm in diameter) does not pass through. Pinhole stricture which an EBD balloon catheter cannot pass through is ineligible.
(b) No stricture in the pharynx and cervical esophagus
(c) No ulceration in the post-ESD stricture. Erosion is acceptable.

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) Severe psychiatric disease.
(5) Receiving continuous systemic steroid or immunosuppressant treatment except steroid for the prevention of stricture after ESD for esophageal cancer.
(6) Patients requiring continuous anticoagulant or antiplatelet drug.
(7) Poorly controlled hypertension.
(8) History of unstable angina within 3 weeks or myocardial infarction within 6 months.

Related Information

• Primary Sponsor: Yano Tomonori
• Source(s) of Monetary Support: National Cancer Center Japan