FLuorescence Cholangiography Using Methylene Blue NCT03386201

Clinical Trial Details — Status: Recruiting

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

Recruitment information / eligibility
Status	Recruiting
Enrollment	40
Est. completion date	June 1, 2018
Est. primary completion date	June 1, 2018
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	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

Drug:
• Intravenous Methylene blue
Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy

Locations
Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors *(2)*
Lead Sponsor	Collaborator
University of Oxford	Oxford University Hospitals NHS Trust

United Kingdom,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Concordance of surgeon anatomy definition with fluorescence outline		Intraoperative (At end of laparoscopic cholecystectomy)
Secondary	Signal to background ratio over time throughout laparoscopic cholecystectomy		0, 10, 20, 30, 40, 50, 60, minutes and at 10 minute intervals thereafter post injection of methylene blue

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