NCT03386201

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

December 18, 2017

Last Update Submit

December 28, 2017

Conditions

Bile Duct Injury

Keywords

Laparoscopic cholecystectomyFluorescence

Outcome Measures

Primary Outcomes (1)

  • Concordance of surgeon anatomy definition with fluorescence outline

    Intraoperative (At end of laparoscopic cholecystectomy)

Secondary Outcomes (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

Study Arms (1)

Intravenous methylene blue

EXPERIMENTAL
Drug: Intravenous Methylene blue

Interventions

Intravenous Methylene blueDRUG

Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy

Intravenous methylene blue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DS, United Kingdom

RECRUITING

Central Study Contacts

Thomas G Barnes, MBChB (Hons)

CONTACT

0300 304 7777thomasbarnes@nds.ox.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

December 18, 2017

First Posted

December 29, 2017

Study Start

January 1, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

December 29, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)