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Fluorescent Cholangiography During Acute Cholecystitis

Primary Purpose

Acute Cholecystitis

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cholangiography
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis focused on measuring Fluorescence, Cholangriography, Cholecystectomy

Eligibility Criteria

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

Inclusion criteria

  • Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window)

Exclusion criteria

  • Laparoscopic operation converted to open operation prior to completed fluorescent and X-ray cholangiography
  • Allergy towards iodine, Iohexol or indocyanine green
  • Legally incompetent (any reason)
  • Cholangitis (as defined above)15
  • Withdrawal of inclusion consent at any time

Sites / Locations

  • Northzealand Hospiral Hillerød
  • Hvidovre University Hospital
  • Zealand University Hospital Køge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluorescent cholangiography

X-ray cholangiography

Arm Description

Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green

Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol

Outcomes

Primary Outcome Measures

Visualizationrate
Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.

Secondary Outcome Measures

Visualizationrate
Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct
Bile duct stones
Percentage of patients with visualization of bile duct stones

Full Information

First Posted
October 29, 2019
Last Updated
April 1, 2020
Sponsor
Hvidovre University Hospital
Collaborators
Hillerod Hospital, Denmark, Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04145869
Brief Title
Fluorescent Cholangiography During Acute Cholecystitis
Official Title
Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Hillerod Hospital, Denmark, Zealand 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
This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
Fluorescence, Cholangriography, Cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluorescent cholangiography
Arm Type
Experimental
Arm Description
Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green
Arm Title
X-ray cholangiography
Arm Type
Active Comparator
Arm Description
Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol
Intervention Type
Procedure
Intervention Name(s)
Cholangiography
Intervention Description
All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography
Primary Outcome Measure Information:
Title
Visualizationrate
Description
Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Visualizationrate
Description
Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct
Time Frame
1 hour
Title
Bile duct stones
Description
Percentage of patients with visualization of bile duct stones
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window) Exclusion criteria Laparoscopic operation converted to open operation prior to completed fluorescent and X-ray cholangiography Allergy towards iodine, Iohexol or indocyanine green Legally incompetent (any reason) Cholangitis (as defined above)15 Withdrawal of inclusion consent at any time
Facility Information:
Facility Name
Northzealand Hospiral Hillerød
City
Hillerød
State/Province
Danmark
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre University Hospital
City
Hvidovre
State/Province
Danmark
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Zealand University Hospital Køge
City
Køge
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Fluorescent Cholangiography During Acute Cholecystitis

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