FLuorescence Cholangiography Using Methylene Blue
Not Applicable
- Conditions
- Bile Duct Injury
- Interventions
- Drug: Intravenous Methylene blue
- Registration Number
- NCT03386201
- Lead Sponsor
- University of Oxford
- Brief Summary
Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intravenous methylene blue Intravenous Methylene blue -
- Primary Outcome Measures
Name Time Method Concordance of surgeon anatomy definition with fluorescence outline Intraoperative (At end of laparoscopic cholecystectomy)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom