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Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy
Plain-language guide to NCT01847612: phase 3 randomized trial of Methylene blue (non-peptide stack partner), 150 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01847612
- Phase
- phase 3
- Status
- completed
- Start
- 2013-07-08
- Completion (planned or actual)
- 2025-07-03
- Participants
- 150 (actual)
- Design
- randomized, single-blind, diagnostic
- Conditions studied
- Liver Disease
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Methylene blue (non-peptide stack partner).
It had two arms (groups): indocyanine green fluorescent cholangiography (experimental) and methylene blue (active comparator).
Use of indocyanine green fluorescent cholangiography in the patients of this arm, an indocyanine green fluorescent cholangiography is performed.
Injection of methylene blue during the surgery.
The registry classes the interventions as drug and procedure.
Who Took Part
Enrollment: 150 actual participants took part.
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: Benin or malignant liver disease with resection of 2 or more segments. Liver resection by laparotomy.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: previous hepatectomy; emergency surgery; allergy to indocyanine green.
How the Study Was Run
Design: randomized, parallel-group and single-blind.
The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Only one side, usually the participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.
Those kept unaware of assignments: outcomes assessor.
It started in 2013-07-08 with completion listed for 2025-07-03.
It ran at 1 site in France.
Its stated primary purpose is diagnostic.
What Was Measured
The main thing measured (primary outcome): biliary fistula rate (time frame: postoperative week 4).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 150 people.
The trial is marked completed; 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.
Related Pages
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.