FLuorescence Cholangiography Using Methylene Blue

University of Oxford40 enrolled

Overview

Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bile Duct Injury

Interventions

Intravenous Methylene blueDRUG

Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 laparoscopic cholecystectomy Exclusion Criteria: * Patient who is unable or unwilling to give informed consent * Known allergy to methylene blue * Risk of serotonin syndrome (taking SSRI / G6PD deficiency / previous serotonin syndrome) * Significant renal failure * Pregnant / planning pregnancy or breastfeeding

Locations (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Concordance of surgeon anatomy definition with fluorescence outline

Time frame: Intraoperative (At end of laparoscopic cholecystectomy)

Secondary Outcomes

Signal to background ratio over time throughout laparoscopic cholecystectomy

Time frame: 0, 10, 20, 30, 40, 50, 60, minutes and at 10 minute intervals thereafter post injection of methylene blue

Central Contacts

Thomas G Barnes, MBChB (Hons)

CONTACT

0300 304 7777 thomasbarnes@nds.ox.ac.uk

Data from ClinicalTrials.gov

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