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FLOTOR Pilot Study (FLOTOR)

Primary Purpose

Chylothorax, Esophageal Cancer, Thoracic Duct Intra-Operative Injury

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chylothorax focused on measuring Fluorescence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Upper GI Surgery, Oxford University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mesenteric ICG

Feeding jejunostomy ICG (cream)

Arm Description

Indocyanine green injected into the small bowel mesentery during oesophagectomy.

Indocyanine green mixed with cream infiltrated into the feeding jejunostomy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Signal to background ratio of fluorescence in thoracic ducts between 2 methods of ICG administration.
Thoracic duct fluorescence levels between methods of ICG administration
Signal to background ratio of fluorescence in thoracic ducts between dosing levels.
Thoracic duct fluorescence levels between ICG doses

Full Information

First Posted
September 18, 2017
Last Updated
November 16, 2018
Sponsor
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03292757
Brief Title
FLOTOR Pilot Study
Acronym
FLOTOR
Official Title
FLuOrescence to Identify the Thoracic Duct During Oesophageal Resections
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chylothorax, Esophageal Cancer, Thoracic Duct Intra-Operative Injury
Keywords
Fluorescence

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenteric ICG
Arm Type
Experimental
Arm Description
Indocyanine green injected into the small bowel mesentery during oesophagectomy.
Arm Title
Feeding jejunostomy ICG (cream)
Arm Type
Experimental
Arm Description
Indocyanine green mixed with cream infiltrated into the feeding jejunostomy.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG
Intervention Description
Fluorescent dye - indocyanine green
Primary Outcome Measure Information:
Title
Number of thoracic ducts seen under fluorescence versus number of thoracic ducts seen with white light. (Change over time)
Description
Thoracic duct visualised fluorescence assessment
Time Frame
0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Secondary Outcome Measure Information:
Title
Signal to background ratio of fluorescence in thoracic ducts between 2 methods of ICG administration.
Description
Thoracic duct fluorescence levels between methods of ICG administration
Time Frame
0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Title
Signal to background ratio of fluorescence in thoracic ducts between dosing levels.
Description
Thoracic duct fluorescence levels between ICG doses
Time Frame
0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gillies, MBChB
Organizational Affiliation
Consultant Upper GI Surgeon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Barnes, MBChB
Organizational Affiliation
Clinical Research Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Upper GI Surgery, Oxford University Hospitals
City
Headington
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data
Citations:
PubMed Identifier
34905086
Citation
Barnes TG, MacGregor T, Sgromo B, Maynard ND, Gillies RS. Near infra-red fluorescence identification of the thoracic duct to prevent chyle leaks during oesophagectomy. Surg Endosc. 2022 Jul;36(7):5319-5325. doi: 10.1007/s00464-021-08912-1. Epub 2021 Dec 14.
Results Reference
derived

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FLOTOR Pilot Study

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