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Status unknownNCT03386201FLoCaMBUpdated Dec 29, 2017

FLuorescence Cholangiography Using Methylene Blue

An interventional study of Intravenous Methylene blue in Bile Duct Injury, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-29.

Sponsored by University of Oxford · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Bile Duct Injury

Keywords

  • Laparoscopic cholecystectomy
  • Fluorescence
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intravenous methylene blue

    Drug: Intravenous Methylene blue

Interventions

  • DrugIntravenous Methylene blue

    Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy

05

What researchers measure

Primary outcomes

  1. Concordance of surgeon anatomy definition with fluorescence outline

    Time frame: Intraoperative (At end of laparoscopic cholecystectomy)

Secondary outcomes

  1. Signal to background ratio over time throughout laparoscopic cholecystectomy

    Time frame: 0, 10, 20, 30, 40, 50, 60, minutes and at 10 minute intervals thereafter post injection of methylene blue

06

Study locations

1 of 1 sites recruiting
  • Oxford University Hospitals NHS Foundation Trust
    Oxford, OX3 9DS, United Kingdom
    • Thomas G Barnes, MBChB (Hons) MRCS · Contact · thomas.barnes@nds.ox.ac.uk · 0300 304 7777
    • Giles Bond-Smith, MBBS FRCS · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03386201
Lead sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust
Responsible party
DrThomasBarnes (Clinical Research Fellow, University of Oxford) — Principal investigator
First posted
Dec 29, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Jun 1, 2018 (estimated)
Completion
Jun 1, 2018 (estimated)
Last update
Dec 29, 2017

Study contacts

Thomas G Barnes, MBChB (Hons)
Contact
thomasbarnes@nds.ox.ac.uk
0300 304 7777

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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