JPRN-jRCTs031180118已完成3 期
JCOG1217: A phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection - Steroid EESD P3
ONO Hiroyuki0 个研究点目标入组 281 人开始时间: 2019年2月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 281
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
3 期
A phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection(JCOG1217, Steroid EESD P3)Early stage esophageal cancer after endoscopic submucosal dissection (ESD)JPRN-UMIN000015064Japan Clinical Oncology Group (JCOG)360
已完成
4 期
Oral Glucocorticosteroid in the Treatment of Severe Asthma Exacerbation in Hospitalized PatientsAsthmaNCT00627731Hamamatsu University50
已完成
不适用
Clinical effectiveness of prednisolone oral administration for esophageal stricture after endoscopic submucosal dissection.esophageal neoplasmJPRN-UMIN000016178agasaki University Hospital30
已完成
不适用
PRedSS: Prednisolone in early diffuse systemic sclerosisSystemic sclerosisISRCTN75313566The University of Manchester35
已完成
2 期
Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye DiseaseThyroid Eye DiseaseNCT04976816Assiut University92