jRCTs031240545招募中不适用
JCOG2315: A randomized controlled phase III study comparing local steroid injection alone versus combination therapy of local steroid injection and oral steroid administration for the prevention of esophageal stricture after wide-spreading endoscopic submucosal dissection (E-COMBI)
未提供0 个研究点目标入组 420 人开始时间: 2024年12月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 85age old under（—）
- 性别
- All
入选标准
- •1st inclusion criteria
- •(1) Meet either of the following.
- •(a) Histologically proven squamous cell carcinoma, basaloid carcinoma, adenosquamous carcinoma, or adenocarcinoma.
- •(b) Histologically proven squamous intraepithelial neoplasia and endoscopically diagnosed as esophageal cancer.
- •(c) No histologically proven esophageal cancer, but endoscopically diagnosed as esophageal cancer.
- •(2) Major lesion and adjacent sub-lesions located in the cervical esophagus to the esophagogastric junction diagnosed by endoscopy.
- •(3) The depth of invasion of the major lesion and sub-lesions is diagnosed as cT1a by endoscopy.
- •(4) Neither lymph node metastases nor distant metastases in neck, chest and abdomen confirmed by contrast-enhanced CT.
- •(5) Circumferential spread of the major lesion is 3/4 or more, but not entire circumference diagnosed by endoscopy
- •(6) Length of major lesion is 80 mm or less in longitudinal axis diagnosed by endoscopy.
- •(7) Circumferential spread is 1/2 or less in all sub-lesions in patients with multiple lesions
- •(8) Aged 18 to 85 years old
- •(9) Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •(10) No prior radiotherapy to the neck, chest wall, lung, or mediastinum
- •(11) No prior surgery for esophagus or mediastinum.
- •(12) No plan of treatment other than protocol treatment for pharyngolarynx and esophagus within 13 weeks after first registration.
- •(13) No prior treatment for esophageal cancer unless all of the following are met.
- •(a) Curative resection (pT1a,Ly0,V0,pVM0) was performed by EMR/ESD.
- •(b) No stricture after EMR/ESD.
- •(c) No past EMR/ESD scar contact with major lesion and adjacent sub-lesions.
- •(14) Dysphagia score >=
- •(15) Sufficient organ function
- •(a) White blood cell count >=2,000/mm3 and <=12,000/mm
- •(b) Hemoglobin >=8.0 g/dL.
- •(c) Platelet >=100,000/mm
- •(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.
- •(h) HbA1c <7.0%
- •(16) Written informed consent
- •2nd inclusion criteria
- •(1) After first registration in this study.
- •(2) ESD and local steroid injection have been performed for esophageal cancer and within 6 days from the date of ESD.
- •(3) En bloc endoscopic resection with no endoscopically evident residual tumor.
- •(4) Circumferential spread of the post-ESD mucosal defect is more than 7/8 but not entire circumference, and the longitudinal diameter of the post-ESD mucosal defect is 100 mm or less.
- •(5) Oral steroid administration is possible.
- •(6) Meet all the following within 1 day.
- •(a) Body temperature <38.0 degrees Celsius
- •(b) Infection <=Grade 0
排除标准
- •(1) Synchronous or metachronous (within 1 year) malignancies.
- •(2) Active infection requiring systemic therapy.
- •(3) Body temperature >=38.0 degrees Celsius.
- •(4) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding.
- •(5) Severe psychiatric disease.
- •(6) Receiving continuous systemic steroid or immunosuppressant treatment.
- •(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, trimethoprim-sulfamethoxazole, proton pump inhibitor, and potassium competitive acid blocker.
- •(18) Glucose-6-phosphate dehydrogenase deficiency.
结局指标
主要结局
-
Stricture-free survival
次要结局
- The number of endoscopic balloon dilation(12 weeks after ESD)
- Proportion of patients with dysphagia score =<1(12 weeks after ESD)
研究者
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