FLuorescence Cholangiography Using Methylene Blue (FLoCaMB)

University of Oxford

Status: Unknown

Conditions: Bile Duct Injury

Treatments: Drug: Intravenous Methylene blue

Study type: Interventional

Funder types: Other

Identifiers

NCT03386201

13174

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intravenous methylene blue

Experimental group

Treatment:

Drug: Intravenous Methylene blue