FLuorescence Cholangiography Using Methylene Blue

Plain-language guide to NCT03386201: not phased interventional trial of Methylene blue (non-peptide stack partner), 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03386201
Phase: not phased
Status: status unknown
Start: 2018-01-01
Completion (planned or actual): 2018-06-01
Participants: 40 (estimated)
Design: na, open label (everyone knows who gets what), other
Conditions studied: Bile Duct Injury
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Methylene blue (non-peptide stack partner).

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

It had 1 arm (groups): Intravenous methylene blue (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: 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).

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-01-01 with completion listed for 2018-06-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Concordance of surgeon anatomy definition with fluorescence outline (time frame: Intraoperative (At end of laparoscopic cholecystectomy)).

It also tracked 1 secondary outcome, for example Signal to background ratio over time throughout laparoscopic cholecystectomy.

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Methylene blue (non-peptide stack partner) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.