Fluorescent Cholangiography and Bile Duct Stones | NCT03530241

Studies
Fluorescent Cholangiography and Bile Duct Stones

NCT03530241

Sponsor

Hvidovre University Hospital

Status

Withdrawn

Last Update Posted

Feb 28, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Gall Stones, Common Bile Duct

Interventions

Presence of bile duct stones
Non-presence of bile duct stones

Countries

Denmark

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No funding

Expanded Access Info

Start Date

Mar 25, 2019Actual

Primary Completion Date

Oct 31, 2020Estimated

Completion Date

Aug 1, 2023Estimated

First Submitted Date

May 8, 2018

First Submission Date that Met QC Criteria

May 8, 2018

First Posted Date

May 21, 2018Actual

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

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection.

Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order.

Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRCP positive	Experimental		Diagnostic Test: Presence of bile duct stones
MRCP negative	Active Comparator		Diagnostic Test: Non-presence of bile duct stones

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Presence of bile duct stones	Diagnostic Test	MRCP verified gall stones in the bile ducts	MRCP positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity	Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography	120mins

Secondary Outcomes

Measure	Description	Time Frame
Visualization	Visualization of the extrahepatic bile ducts	120mins

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Patients suspected of having bile duct stones by either blood samples, MRCP or medical history (see definitions)
Patient age ≥ 18 years
Preoperative MRCP
Operation performed by a project surgeon

Exclusion criteria

Open cholecystectomy (including conversion from laparoscopic to open)
Acute cholecytitis or cholangitis
Pancreatitis
Iodine or indocyanine green allergy
Liver or renal insufficiency
Thyrotoxicosis
Cholecystectomy not the primary surgical procedure
Pregnancy or lactation
Legally incompetent for any reason
Withdrawal of inclusion consent at any time

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

Not provided

Overall Officials

Name	Affiliation	Role
Lars L Lehrskov, MD	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Holte	Danmark	2840	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis

Browse Leaves

Not provided

Browse Branches

Not provided