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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03386201
Other study ID # 13174
Secondary ID
Status Recruiting
Phase N/A
First received December 18, 2017
Last updated December 28, 2017
Start date January 1, 2018
Est. completion date June 1, 2018

Study information

Verified date December 2017
Source University of Oxford
Contact Thomas G Barnes, MBChB (Hons)
Phone 0300 304 7777
Email thomasbarnes@nds.ox.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Oxford University Hospitals NHS Foundation Trust Oxford

Sponsors (2)

Lead Sponsor Collaborator
University of Oxford Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concordance of surgeon anatomy definition with fluorescence outline Intraoperative (At end of laparoscopic cholecystectomy)
Secondary 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
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