FLuorescence Cholangiography Using Methylene Blue (FLoCaMB)

December 28, 2017 updated by: DrThomasBarnes, University of Oxford
Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 9DS
        • Recruiting
        • Oxford University Hospitals Nhs Foundation Trust
        • Contact:
        • Sub-Investigator:
          • Giles Bond-Smith, MBBS FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous methylene blue
Drug: Intravenous Methylene blue
Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concordance of surgeon anatomy definition with fluorescence outline
Time Frame: Intraoperative (At end of laparoscopic cholecystectomy)
Intraoperative (At end of laparoscopic cholecystectomy)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Oxford University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 28, 2017

First Posted (Actual)

December 29, 2017

Study Record Updates

Last Update Posted (Actual)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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