EUCTR2020-003974-33-IT进行中（未招募）1 期
Thoracic duct identification with indocyanine green fluorescence during esophagectomy - VERDEDT 2.0
AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE0 个研究点目标入组 100 人开始时间: 2021年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient aged 18 or over diagnosed with esophageal neoplasia or GEJ undergoing thoracoscopic and thoracotomy esophagectomy.
- •2. American Society of Anesthesiologists (ASA) class I, II or III
- •3. Elective surgery
- •4. Patients' written acceptance to be included in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Class IV-V of the American Society of Anesthesiologists (ASA)
- •2. Patients with hyperthyroidism and/or autoimmune adenomas of the thyroid
- •3. Allergy to contrast medium, hypersensitivity to iodine, indocyanine green or sodium iodine.
- •4. Patients who cannot undergo transthoracic esophagectomy.
- •5. Pregnancy or breastfeeding or positive pregnancy test (tone performed in potentially fertile women)
- •6. Severe kidney failure (estimated GFR <30 ml/min/1.73 m2 at the time of screening)
- •7. Partecipation in a clinical study in which an experimental drug was administered within 30 days or half-lives of the study drug.
- •8. Any clinical condition that in the investigator's judgment would make the patient unsuitable for the study
- •9. Patients who refuse to give their written consent to partecipate in the study
研究者
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