FLOTOR Pilot Study

NCT03292757 | Completed Phase 1

• 1 other identifier: 12968
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Chylothorax; Esophageal Cancer; Thoracic Duct Intra-Operative Injury

Keywords

Fluorescence

Outcome Measures

Primary Outcomes (1)

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

  Thoracic duct visualised fluorescence assessment

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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Mesenteric ICG

EXPERIMENTAL

Indocyanine green injected into the small bowel mesentery during oesophagectomy.

Drug: Indocyanine Green

Feeding jejunostomy ICG (cream)

EXPERIMENTAL

Indocyanine green mixed with cream infiltrated into the feeding jejunostomy.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Fluorescent dye - indocyanine green

Also known as: ICG

Feeding jejunostomy ICG (cream); Mesenteric ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Department of Upper GI Surgery, Oxford University Hospitals

Headington, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34905086 DERIVED

MeSH Terms

Conditions

Chylothorax; Esophageal Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Richard Gillies, MBChB

  Consultant Upper GI Surgeon

  PRINCIPAL INVESTIGATOR

• Thomas Barnes, MBChB

  Clinical Research Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 26, 2017
• Study Start: December 20, 2017
• Primary Completion: August 20, 2018
• Study Completion: September 20, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)