FLuorescence Cholangiography Using Methylene Blue

NCT ID: NCT03386201

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bile Duct Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Laparoscopic cholecystectomy Fluorescence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous methylene blue

Group Type EXPERIMENTAL

Intravenous Methylene blue

Intervention Type DRUG

Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous Methylene blue

Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

DrThomasBarnes

Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas G Barnes, MBChB (Hons)

Role: CONTACT

Phone: 0300 304 7777

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thomas G Barnes, MBChB (Hons) MRCS

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13174

Identifier Type: -

Identifier Source: org_study_id