Bile Duct InjuryFLoCaMBNCT03386201
FLuorescence Cholangiography Using Methylene Blue
A study testing Intravenous Methylene blue in people with Bile Duct Injury, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Injury
- What is being tested?
- Intravenous Methylene blue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DS
Thomas G Barnes, MBChB (Hons) MRCS, 0300 304 7777, thomas.barnes@nds.ox.ac.uk
Giles Bond-Smith, MBBS FRCS
About this study
Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.
- Conditions
- Bile Duct Injury
- Being tested
- Intravenous Methylene blue
- Keywords
- Laparoscopic cholecystectomy, Fluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Methylene blueDrug
Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Intravenous methylene blue | Experimental | Not described Receives: Drug: Intravenous Methylene blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of surgeon anatomy definition with fluorescence outline
Measured: Intraoperative (At end of laparoscopic cholecystectomy)
Secondary outcomes (1)
Signal to background ratio over time throughout laparoscopic cholecystectomy
Measured: 0, 10, 20, 30, 40, 50, 60, minutes and at 10 minute intervals thereafter post injection of methylene blue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct InjuryStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Principal investigator, DrThomasBarnes, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386201
- Sponsor's protocol ID
- 13174
- Acronym
- FLoCaMB
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLuorescence Cholangiography Using Methylene Blue
- ClinicalTrials.gov ID
- NCT03386201
- Acronym / sponsor ID
- FLoCaMB / 13174
- Conditions
- Bile Duct Injury
- Keywords
- Laparoscopic cholecystectomy, Fluorescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous methylene blue | Experimental | Drug: Intravenous Methylene blue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Methylene blueMethylene blue fluorescence cholangiography during laparoscopic cholecystectomy | Drug | Intravenous methylene blue |
Primary outcome
Concordance of surgeon anatomy definition with fluorescence outline
Time frame: Intraoperative (At end of laparoscopic cholecystectomy)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Methylene blue in people with Bile Duct Injury, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas G Barnes, MBChB (Hons) (0300 304 7777, thomasbarnes@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of surgeon anatomy definition with fluorescence outline (time frame: Intraoperative (At end of laparoscopic cholecystectomy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.