Gall Stones, Common Bile DuctNCT03530241
Fluorescent Cholangiography and Bile Duct Stones
A study testing Presence of bile duct stones and Non-presence of bile duct stones in people with Gall Stones, Common Bile Duct, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gall Stones, Common Bile Duct
- What is being tested?
- Presence of bile duct stones and Non-presence of bile duct stones
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Mar 2019to 1 Aug 2023
- 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
- 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
Who cannot join
- Open cholecystectomy (including conversion from laparoscopic to open)
- Acute cholecytitis or cholangitis
- Pancreatitis
- Iodine or indocyanine green allergy
- Liver or renal insufficiency
- Thyrotoxicosis
Show all 10Show fewer
- Cholecystectomy not the primary surgical procedure
- Pregnancy or lactation
- Legally incompetent for any reason
- Withdrawal of inclusion consent at any time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensitivity and Specificity of Fluorescent Cholangiography to Detect Bile Duct Stones in Patients Undergoing Laparoscopic Cholecystectomy
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.
- Conditions
- Gall Stones, Common Bile Duct
- Being tested
- Presence of bile duct stones, Non-presence of bile duct stones
- Keywords
- fluorescence, cholangiography, cholecystectomy, laparoscopic
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of bile duct stonesDiagnostic test
MRCP verified gall stones in the bile ducts
Non-presence of bile duct stonesDiagnostic test
MRCP without bile duct stones
| Study group | Role | What they receive |
|---|---|---|
| MRCP positive | Experimental | Not described Receives: Diagnostic Test: Presence of bile duct stones |
| MRCP negative | Active comparator | Not described Receives: Diagnostic Test: Non-presence of bile duct stones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography
Measured: 120mins
Secondary outcomes (1)
Visualization
Visualization of the extrahepatic bile ducts
Measured: 120mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start25 Mar 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion1 Aug 2023 (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 Gall Stones, Common Bile DuctStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Lang Lehrskov, Hvidovre University Hospital
- Investigators
- Lars L Lehrskov, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530241
- Sponsor's protocol ID
- IFC4
- Status last verified
- Feb 2024
- First submitted
- 8 May 2018
- 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
- Sensitivity and Specificity of Fluorescent Cholangiography to Detect Bile Duct Stones in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03530241
- Acronym / sponsor ID
- IFC4
- Conditions
- Gall Stones, Common Bile Duct
- Keywords
- fluorescence, cholangiography, cholecystectomy, laparoscopic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 21 May 2018 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRCP positive | Experimental | Diagnostic Test: Presence of bile duct stones |
| MRCP negative | Active comparator | Diagnostic Test: Non-presence of bile duct stones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Open cholecystectomy (including conversion from laparoscopic to open)
- Acute cholecytitis or cholangitis
- Pancreatitis
- Iodine or indocyanine green allergy
- Liver or renal insufficiency
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 |
|---|---|---|
| Presence of bile duct stonesMRCP verified gall stones in the bile ducts | Diagnostic test | MRCP positive |
| Non-presence of bile duct stonesMRCP without bile duct stones | Diagnostic test | MRCP negative |
Primary outcome
Sensitivity and specificity
Time frame: 120mins
Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography
1 secondary outcome
Visualization
Time frame: 120mins
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
Related trials for Gall Stones, Common Bile Duct
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones
Recruiting
Laparoendoscopic Rendezvous for Concomitant Gall Bladder Stones and Common Bile Duct Stones
Gall Stone, Common Bile Duct Calculi
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.
Lars L Lehrskov, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presence of bile duct stones and Non-presence of bile duct stones in people with Gall Stones, Common Bile Duct, run by Hvidovre University Hospital at 1 site 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 4 inclusion and 10 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 1 site 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?
Sensitivity and specificity (time frame: 120mins). 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; AzTrials last refreshed its copy on 26 Oct 2026.