Fluorescent Cholangiography During Acute Cholecystitis

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04145869

Collaborator

Hillerod Hospital, Denmark (Other), Zealand University Hospital (Other)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

66.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis	Procedure: Cholangiography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluorescent cholangiography Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green	Procedure: Cholangiography All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography
Active Comparator: X-ray cholangiography Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol	Procedure: Cholangiography All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography

Arm

Intervention/Treatment

Experimental: Fluorescent cholangiography

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

Procedure: Cholangiography

All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography

Active Comparator: X-ray cholangiography

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

Procedure: Cholangiography

All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography

Outcome Measures

Primary Outcome Measures

Visualizationrate [1 hour]
Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.

Secondary Outcome Measures

Visualizationrate [1 hour]
Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct
Bile duct stones [1 hour]
Percentage of patients with visualization of bile duct stones

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northzealand Hospiral Hillerød	Hillerød	Danmark	Denmark	3400
2	Hvidovre University Hospital	Hvidovre	Danmark	Denmark	2650
3	Zealand University Hospital Køge	Køge		Denmark	4600