NCT04145869

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3.9 years

First QC Date

October 29, 2019

Last Update Submit

February 26, 2024

Conditions

Acute Cholecystitis

Keywords

FluorescenceCholangriographyCholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Visualizationrate

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

    1 hour

Secondary Outcomes (2)

  • Visualizationrate

    1 hour

  • Bile duct stones

    1 hour

Study Arms (2)

Fluorescent cholangiography

EXPERIMENTAL

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

Procedure: Cholangiography

X-ray cholangiography

ACTIVE COMPARATOR

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

Procedure: Cholangiography

Interventions

CholangiographyPROCEDURE

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

Fluorescent cholangiographyX-ray cholangiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northzealand Hospiral Hillerød

Hillerød, Danmark, 3400, Denmark

Location

Hvidovre University Hospital

Hvidovre, Danmark, 2650, Denmark

Location

Zealand University Hospital Køge

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 29, 2019

First Posted

October 31, 2019

Study Start

April 1, 2020

Primary Completion

March 1, 2024

Study Completion

March 1, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

DK(3)