Acute CholecystitisNCT04145869
Fluorescent Cholangiography During Acute Cholecystitis
A study testing Cholangiography in people with Acute Cholecystitis, run by Hvidovre University Hospital at 3 sites in Denmark.
Trial summary
This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Cholangiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Apr 2020to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Northzealand Hospiral Hillerød
Hillerød, Danmark, 3400
Hvidovre University Hospital
Hvidovre, Danmark, 2650
Zealand University Hospital Køge
Køge, 4600
About this study
Official title: Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis
This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis
- Conditions
- Acute Cholecystitis
- Being tested
- Cholangiography
- Keywords
- Fluorescence, Cholangriography, Cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholangiographyProcedure or surgery
All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography
| Study group | Role | What they receive |
|---|---|---|
| Fluorescent cholangiography | Experimental | Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green Receives: Procedure: Cholangiography |
| X-ray cholangiography | Active comparator | Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol Receives: Procedure: Cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualizationrate
Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.
Measured: 1 hour
Secondary outcomes (2)
Visualizationrate
Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct
Measured: 1 hour
Bile duct stones
Percentage of patients with visualization of bile duct stones
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Apr 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hillerod Hospital, Denmark, Zealand University Hospital
- Responsible party
- Principal investigator, Lars Lang Lehrskov, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145869
- Sponsor's protocol ID
- IFC3
- Status last verified
- Feb 2024
- First submitted
- 29 Oct 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT04145869
- Acronym / sponsor ID
- IFC3
- Conditions
- Acute Cholecystitis
- Keywords
- Fluorescence, Cholangriography, Cholecystectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Hillerod Hospital, Denmark, Zealand University Hospital
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescent cholangiography | Experimental | Procedure: CholangiographyIntraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green |
| X-ray cholangiography | Active comparator | Procedure: CholangiographyIntraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholangiographyAll patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography | Procedure or surgery | Fluorescent cholangiography, X-ray cholangiography |
Primary outcome
Visualizationrate
Time frame: 1 hour
Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.
2 secondary outcomes
Visualizationrate
Time frame: 1 hour
Bile duct stones
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholangiography in people with Acute Cholecystitis, run by Hvidovre University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualizationrate (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.