FLuorescence Cholangiography Using Methylene Blue | NCT03386201

Studies
FLuorescence Cholangiography Using Methylene Blue

NCT03386201

Sponsor

University of Oxford

Status

Unknown status

Last Update Posted

Dec 29, 2017Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Bile Duct Injury

Interventions

Intravenous Methylene blue

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Jun 1, 2018Estimated

Completion Date

Jun 1, 2018Estimated

First Submitted Date

Dec 18, 2017

First Submission Date that Met QC Criteria

Dec 28, 2017

First Posted Date

Dec 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2017

Last Update Posted Date

Dec 29, 2017Actual

Name	Class
Oxford University Hospitals NHS Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous methylene blue	Experimental		Drug: Intravenous Methylene blue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous Methylene blue	Drug	Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy	Intravenous methylene blue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concordance of surgeon anatomy definition with fluorescence outline		Intraoperative (At end of laparoscopic cholecystectomy)

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas G Barnes, MBChB (Hons)	Contact	0300 304 7777		thomasbarnes@nds.ox.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oxford University Hospitals NHS Foundation Trust	Recruiting	Oxford		OX3 9DS	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided