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临床试验/NCT03292757
NCT03292757已完成1 期

FLuOrescence to Identify the Thoracic Duct During Oesophageal Resections

Oxford University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
21
试验地点
1
主要终点
Number of thoracic ducts seen under fluorescence versus number of thoracic ducts seen with white light. (Change over time)

研究概览

简要总结

This is a non-randomised study assessing the technique of using indocyanine green as a fluorescent dye to highlight the thoracic duct during oesophectomy.

详细描述

The thoracic duct is the largest vessel of the lymphatic system in the body. It transports chyle (a liquid containing both lymph and emulsified fats) from most of the body, including the gastrointestinal tract, into the left internal jugular vein. It is largely located in the thorax and is at risk of injury during the thoracic part of an oesophagectomy.

The reported incidence of thoracic duct injury during oesophagectomy is between 0.2 and 10.5%, although it may be under-reported in the literature. A review of prospective collected complication data from 292 consecutive oesophagectomies performed in Oxford over a 5 year period revealed a chyle leak rate of 9.9%. Chyle leak was associated in a doubling of median length of post-operative stay from 8 to 16 days in these patients. Chylothorax has been associated with a mortality of up to 30%.

Over the years, a number of attempts have been made to visualise chyle leakage following thoracic duct injury including administration of enteral fat containing feed (e.g. double cream), methylene blue and lymphoscintigraphy, but no studies have been published showing a mechanism to aid thoracic duct identification at the index operation, and so prevent injuries.

Fluorescence is a technique which uses fluorescent dyes (fluorophores) that emit invisible (near infra-red (NIR)) light when they are excited by light at a particular wavelength. In order to use this technique, a fluorescence-enabled camera is required in order to shine light at that particular wavelength on the fluorophore and to capture the light emitted. This is then displayed on a screen for the surgeon to see.

Indocyanine green (ICG) is a fluorescent molecule that is approved by the FDA (Food and Drug Administration) and the MHRA for use in humans. It is a widely used near infra-red dye for numerous operations. Near infra-red guided lymphatic mapping with ICG has gained much attention over recent years and its use has widely been published in breast and colorectal surgery. ICG has also been successfully used to identify the thoracic duct in a number of case reports in both adults and children.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Undergoing elective oesophagectomy

排除标准

  • Known allergy to iodine or ICG
  • Female patient who is pregnant, planning pregnancy or breastfeeding
  • Patient has a lactose intolerance (excluded only from receiving cream method)
  • Known significant liver failure

研究组 & 干预措施

Feeding jejunostomy ICG (cream)

Experimental

Indocyanine green mixed with cream infiltrated into the feeding jejunostomy.

干预措施: Indocyanine Green (Drug)

Mesenteric ICG

Experimental

Indocyanine green injected into the small bowel mesentery during oesophagectomy.

干预措施: Indocyanine Green (Drug)

结局指标

主要结局

Number of thoracic ducts seen under fluorescence versus number of thoracic ducts seen with white light. (Change over time)

时间窗: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose

Thoracic duct visualised fluorescence assessment

次要结局

  • Signal to background ratio of fluorescence in thoracic ducts between dosing levels.(0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose)
  • Signal to background ratio of fluorescence in thoracic ducts between 2 methods of ICG administration.(0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Barnes

Clinical Research Fellow

Oxford University Hospitals NHS Trust

研究点 (1)

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