JPRN-jRCTs062220110招募中2 期
Exploratory Clinical Study on the Efficacy and Safety of Peptide-Derived Hemostatic Material for the Prevention of Esophageal Stenosis after Endoscopic Submucosal Dissection of Superficial Esophageal Carcinoma
Oka Shiro0 个研究点目标入组 20 人开始时间: 2023年3月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1. Histologically confirmed primary squamous cell carcinoma (including HGIN) or basal cell carcinoma of the esophagus by endoscopic biopsy.
- •2. Endoscopic diagnosis of tumor confined to the thoracic esophagus.
- •3. Endoscopic diagnosis of tumor wall depth within the epithelium (EP), mucosal lamina propria (LPM), or mucosal muscularis mucosae (MM).
- •4. No evidence of lymph node or distant metastasis on cervical to abdominal contrast-enhanced CT or PET-CT. Simple CT is acceptable in the presence of renal dysfunction, contrast allergy, or bronchial asthma.
- •5. The tumor is more than 1/2 circumferential and non-total circumferential. If the tumor is more than 1/2 circumferential and non-peripheral, the circumference of the resected area is expected to be 3/4 circumferential to subperipheral.
- •6. Tumor diameter is less than 50 mm in the longitudinal direction at endoscopic examination.
- •7. If multiple lesions are present, all secondary lesions except the most circumscribed lesion (main lesion) have a circumference of less than 1/2 circumference.
- •8. Age on the date consent is obtained is at least 18 years old and less than 85 years old.
- •9. Performance status (PS) is 0-1 according to ECOG criteria.
- •10. No prior radiation therapy to the cervicothoracic region, lung fields, or mediastinum, including treatment for other types of carcinoma.
- •11. No previous surgery to the esophagus or mediastinum, including treatment for benign tumors.
- •12. No prior treatment for esophageal carcinoma.
- •13. Dysphagia score is 0.
- •14. The most recent laboratory values within 90 days prior to provisional enrollment meet all of the following
- •(1) White blood cell count >=2,000/mm3 and <=12,000/mm3
- •(2) Hemoglobin >=8.0 g/dL
- •(3) Platelet count >=10,000/ mm3
- •(4) Total bilirubin <=2.0 mg/dL
- •(5) AST (GOT) <=150 IU/L
- •(6) ALT (GPT) <=150 IU/L
- •(7) Serum creatinine <=2.0 mg/dL
- •(8) Hemoglobin A1c (international standard (NGSP) value) <7.0
- •15. The patient's written consent to participate in the study has been obtained.
- •16. ESD was performed, and at the end of ESD, the resection area was confirmed to be 3/4 circumference to sub-total circumference.
排除标准
- •1. Active overlapping cancers.
- •2. Infections requiring systemic treatment.
- •3. Fever of 38 degrees or higher at axillary temperature at the time of registration.
- •4. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
- •5. Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study.
- •6. Receiving continuous systemic administration of steroids or other immunosuppressive agents.
- •7. Receiving a steroid combination inhaler.
- •8. Complicated by poorly controlled hypertension.
- •9. Complicated unstable angina (angina with onset or worsening attacks within the last 3 weeks) or history of myocardial infarction within 6 months.
- •10. Complicated respiratory disease requiring continuous oxygen administration.
- •11. Previous surgery within 3 months (regardless of surgical site).
- •12. History of hypersensitivity to peptide or protein preparations.
研究者
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