Gall Stone DiseaseNCT02136095
Promising Initial Experience With Intra-operative Fluorescent Cholangiography
A study testing Intraoperative fluorescent cholangiography (IFC) in people with Gall Stone Disease, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is a recently developed method for non-invasive visualisation of the relevant anatomy during laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gall Stone Disease
- What is being tested?
- Intraoperative fluorescent cholangiography (IFC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Dec 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Scheduled for acute- or elective laparoscopic cholecystectomy
- Informed consent
Who cannot join
- Known iodine-hypersensitivity
- Liver- or renal insufficiency
- Known thyrotoxicosis
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is a recently developed method for non-invasive visualisation of the relevant anatomy during laparoscopic cholecystectomy. The objective of this study was to assess the time required by routine-use of IFC and to evaluate success-rate of the procedures.
Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the same surgeon were consecutively enrolled. A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative time-registration and exposure of predefined anatomical structures were recorded.
- Conditions
- Gall Stone Disease
- Being tested
- Intraoperative fluorescent cholangiography (IFC)
- Keywords
- Fluorescent cholangiography, Laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative fluorescent cholangiography (IFC)Procedure or surgery
A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| IFC-group | Experimental | The investigators included patients undergoing laparoscopic cholecystectomy by a single surgeon between September and December 2013 at a single centre university department with unrestricted referral of patients. The included patients represented all patients undergoing laparoscopic cholecystectomy by one surgeon during the study period. All patients underwent intra-operative fluorescent cholangiography (IFC) with concomitant angiography, according to a standardized protocol, during their laparoscopic cholecystectomy. Receives: Procedure: Intraoperative fluorescent cholangiography (IFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time expenditure of IFC with concomitant angiography.
Intra-operative fluorescent-imaging-mode-time was registered by a study-nurse during the operations (performed between september and december 2013)
Measured: Four months
Secondary outcomes (1)
Success-rate of the IFC-procedures.
The operating surgeon completed a structured questionnaire immediately after each operation regarding anatomical identification by IFC (visible cystic duct, -common bile duct, -common hepatic duct, -right and left hepatic ducts, -cystic artery, -aberrant bile ducts, and/or other abnormalities).
Successful IFC was defined as exposure of the junction between the cystic duct, common bile duct and common hepatic duct by IFC. Success-full fluorescent angiography was defined as adequate visualisation of the cystic artery within Calot´s triangle by the method.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gall Stone DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Søren S. Larsen, Hvidovre University Hospital
- Investigators
- Søren Larsen, MD, PhD, Principal investigator, Gastroenheden, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136095
- Sponsor's protocol ID
- IFC_Feasibility_study
- Status last verified
- May 2014
- First submitted
- 7 May 2014
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Larsen SS, Schulze S, Bisgaard T. Non-radiographic intraoperative fluorescent cholangiography is feasible. Dan Med J. 2014 Aug;61(8):A4891.
PubMed 25162446
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promising Initial Experience With Intra-operative Fluorescent Cholangiography
- ClinicalTrials.gov ID
- NCT02136095
- Acronym / sponsor ID
- IFC_Feasibility_study
- Conditions
- Gall Stone Disease
- Keywords
- Fluorescent cholangiography, Laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 May 2014 (estimated)
- 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.
Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is a recently developed method for non-invasive visualisation of the relevant anatomy during laparoscopic cholecystectomy. The objective of this study was to assess the time required by routine-use of IFC and to evaluate success-rate of the procedures.
Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the same surgeon were consecutively enrolled. A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative time-registration and exposure of predefined anatomical structures were recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFC-group | Experimental | Procedure: Intraoperative fluorescent cholangiography (IFC)The investigators included patients undergoing laparoscopic cholecystectomy by a single surgeon between September and December 2013 at a single centre university department with unrestricted referral of patients. The included patients represented all patients undergoing laparoscopic cholecystectomy by one surgeon during the study period. All patients underwent intra-operative fluorescent cholangiography (IFC) with concomitant angiography, according to a standardized protocol, during their laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Scheduled for acute- or elective laparoscopic cholecystectomy
- Informed consent
Key exclusion criteria (4 listed)
- Known iodine-hypersensitivity
- Liver- or renal insufficiency
- Known thyrotoxicosis
- Pregnancy or lactation
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 |
|---|---|---|
| Intraoperative fluorescent cholangiography (IFC)A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy. | Procedure or surgery | IFC-group |
Primary outcome
Time expenditure of IFC with concomitant angiography.
Time frame: Four months
Intra-operative fluorescent-imaging-mode-time was registered by a study-nurse during the operations (performed between september and december 2013)
1 secondary outcome
Success-rate of the IFC-procedures.
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
- Derived from this study: PubMed 25162446Larsen SS, Schulze S, Bisgaard T. Non-radiographic intraoperative fluorescent cholangiography is feasible. Dan Med J. 2014 Aug;61(8):A4891.
Related trials for Gall Stone Disease
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
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
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.
Søren Larsen, MD, PhD principal investigator
Gastroenheden, 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 Intraoperative fluorescent cholangiography (IFC) in people with Gall Stone Disease, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 May 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time expenditure of IFC with concomitant angiography. (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136095, which also lists 1 linked publication.
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 12 May 2014.