JCOG1217: A phase III study for the prevention of esophageal stricture after endoscopic submucosal dissectio

Phase 3

• Conditions: Early stage esophageal cancer after endoscopic submucosal dissection (ESD)

• Registration Number: JPRN-jRCTs031180118
• Lead Sponsor: ONO Hiroyuki

Brief Summary

The superiority of oral prednisolone administration to local triamcinolone injection in stricture free survival after esophageal ESD was not shown. Therefore, local triamcinolone injection is the standard treatment for the prevention of esophageal stricture after ESD for wide-spread superficial esophageal cancer.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-13
• Study Completion: 2022-05-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 281

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 except for the following:
(i)Major lesion located within 20 mm from past EMR/ESD scar.
(ii) Inability to pass a standard endoscope with a diameter of 9.6-10.4 mm through the stricture site due to past EMR/ESD scar.13) Dysphagia score of 0 14) Adequate organ functions
(i) White blood cell count >=2000/mm3 and <=12 000/mm3.
(ii) Hemoglobin >=8.0 g/dl.
(iii) Platelet >=100 000/mm3.
(iv) Total bilirubin <=2.0 mg/dl.
(v) Aspartate aminotransferase <=150 IU/l.
(vi) Alanine aminotransferase <=150 IU/l.
(vii) Creatinine <=2.0 mg/dl.
(viii) HbA1c < 7.0%.
15) Written informed consent

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) History 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,examination by ophthalmologist is not necessarily required
14) History of any surgery within 3 months
15) Positive HBs antigen
16) Allergy to Iodine
17) Hypersensitivity for triamcinolone acetonide, prednisolone, proton pump inhibitor, and trimethoprim-sulfamethoxazole.
18) Glucose-6-phosphate dehydrogenase deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified