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Completed

NCT Number: NCT03292757

FLOTOR Pilot Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Upper GI Surgery, Oxford University Hospitals

Headington, Oxfordshire, OX3 7LE, United Kingdom

About this study

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.

ICG can be injected into the small bowel mesentery to aid identification of thoracic duct injury at re-exploration. This study aims to assess the feasibility of using ICG fluorescence to identify the thoracic duct during oesophagectomy, with the eventual aim of developing its routine use to prevent thoracic duct injuries.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Indocyanine green

Drug

Fluorescent dye - indocyanine green

Other names: ICG

Primary outcomes

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

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

    Thoracic duct visualised fluorescence assessment

Secondary outcomes

  1. Signal to background ratio of fluorescence in thoracic ducts between 2 methods of ICG administration.

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

    Thoracic duct fluorescence levels between methods of ICG administration

  2. Signal to background ratio of fluorescence in thoracic ducts between dosing levels.

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

    Thoracic duct fluorescence levels between ICG doses

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study title

FLuOrescence to Identify the Thoracic Duct During Oesophageal Resections

Acronym: FLOTOR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2017
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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