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Fluorescent Cholangiography and Bile Duct Stones

Primary Purpose

Gall Stones, Common Bile Duct

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Presence of bile duct stones
Non-presence of bile duct stones
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gall Stones, Common Bile Duct focused on measuring fluorescence, cholangiography, cholecystectomy, laparoscopic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MRCP positive

MRCP negative

Arm Description

Outcomes

Primary Outcome Measures

Sensitivity and specificity
Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography

Secondary Outcome Measures

Visualization
Visualization of the extrahepatic bile ducts

Full Information

First Posted
May 8, 2018
Last Updated
April 1, 2020
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03530241
Brief Title
Fluorescent Cholangiography and Bile Duct Stones
Official Title
Sensitivity and Specificity of Fluorescent Cholangiography to Detect Bile Duct Stones in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gall Stones, Common Bile Duct
Keywords
fluorescence, cholangiography, cholecystectomy, laparoscopic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRCP positive
Arm Type
Experimental
Arm Title
MRCP negative
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Presence of bile duct stones
Intervention Description
MRCP verified gall stones in the bile ducts
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-presence of bile duct stones
Intervention Description
MRCP without bile duct stones
Primary Outcome Measure Information:
Title
Sensitivity and specificity
Description
Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography
Time Frame
120mins
Secondary Outcome Measure Information:
Title
Visualization
Description
Visualization of the extrahepatic bile ducts
Time Frame
120mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars L Lehrskov, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Holte
State/Province
Danmark
ZIP/Postal Code
2840
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Fluorescent Cholangiography and Bile Duct Stones

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