Bile Duct Injury
Conditions
Keywords
Laparoscopic cholecystectomy, Fluorescence
Brief summary
Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.
Interventions
DRUGIntravenous Methylene blue
Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy
Sponsors
Oxford University Hospitals NHS Trust
University of Oxford
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concordance of surgeon anatomy definition with fluorescence outline | Intraoperative (At end of laparoscopic cholecystectomy) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Contacts
Primary ContactThomas G Barnes, MBChB (Hons)
Outcome results
None listed