FLuorescence Cholangiography Using Methylene Blue

NCT03386201 — Not applicable, Unknown, 40 participants, University of Oxford

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Registry	NCT03386201, acronym FLoCaMB
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	40 (Estimated)
Sponsor	University of Oxford (Other); collaborators: Oxford University Hospitals NHS Trust
Conditions	Bile Duct Injury
Interventions	Intravenous Methylene blue (Drug)
Dates	start 2018-01-01 (estimated), primary completion 2018-06-01 (estimated), completion 2018-06-01 (estimated), first posted 2017-12-29, last updated 2017-12-29
Locations	1 site in United Kingdom

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Intravenous methylene blue	Experimental	Drug: Intravenous Methylene blue

Intravenous Methylene blue (Drug): Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy

+Outcome measures

Primary outcomes

Concordance of surgeon anatomy definition with fluorescence outline [Intraoperative (At end of laparoscopic cholecystectomy)]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country	Status
Oxford University Hospitals NHS Foundation Trust	Oxford	United Kingdom	Recruiting

My Notes

Public

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