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FLoCaMB: FLuorescence Cholangiography Using Methylene Blue

Sponsor
University of Oxford (Other)
Overall Status
Unknown status
CT.gov ID
NCT03386201
Collaborator
Oxford University Hospitals NHS Trust (Other)
40
Enrollment
1
Location
1
Arm
5
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous Methylene blue
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
FLuorescence Cholangiography Using Methylene Blue
Anticipated Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intravenous methylene blue

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. 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 Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom OX3 9DS

Sponsors and Collaborators

  • University of Oxford
  • Oxford University Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DrThomasBarnes, Clinical Research Fellow, University of Oxford
ClinicalTrials.gov Identifier:
NCT03386201
Other Study ID Numbers:
  • 13174
First Posted:
Dec 29, 2017
Last Update Posted:
Dec 29, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by DrThomasBarnes, Clinical Research Fellow, University of Oxford
Laparoscopic cholecystectomy
Fluorescence
Additional relevant MeSH terms:
Methylene Blue

Study Results

No Results Posted as of Dec 29, 2017