CTRI/2025/05/087514尚未招募2/3 期
Feasibility and safety of indocyanine green nebulization for identification of tracheobronchial tree in patients undergoing minimally invasive esophagectomy - a pilot study
Surgical Gastroenterology Department AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月3日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Florescence Of Tracheo-Bronchial Tree
研究概览
简要总结
Use of ICG fluorescence-guided surgery can assist the surgeon in identifying the trachea-bronchial tree and hence prevent its injury intra-operatively. This may lead to improved post operative outcome and reduced post op stay of patient.
Use of ICG in an aerosol form via this nebulisation route has not been described to assess trachea-bronchial tree before and the aim of this study is to assess thefeasibility and safety of the same.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between the age of 18-80 years
- •Patients willing to participate in the study by giving a written informed consent.
- •ECOG less or equal to 2
- •All patients undergoing MIE for esophageal and esophagogastric junction malignancy or benign pathology.
排除标准
- •Age of patients less than 18 year
- •Allergy to Iodine or ICG
- •Patient not willing to be a part of study
- •Patients unfit for GA.
结局指标
主要结局
Florescence Of Tracheo-Bronchial Tree
时间窗: Before beginning of esophageal mobilisation and then it will be noted till end of surgery before removing port
次要结局
- Tracheo-bronchial injury identified intra-operatively(Intra-operatively at any point of time)
研究者
Dr Aman Bansal
AIIMS Rishikesh
研究点 (1)
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