CholelithiasisFLARIOCNCT01881399
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
A study testing Fluorescence cholangiography (da Vinci surgical system), Virtual cholangiography and Conventional IOC in people with Cholelithiasis and Gallbladder Polyps, run by IHU Strasbourg at 1 site in France.
Trial summary
The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis, Gallbladder Polyps
- What is being tested?
- Fluorescence cholangiography (da Vinci surgical system), Virtual cholangiography and Conventional IOC
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jun 2016
- 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
- Man or woman > 18 years old
- Symptomatic gallbladder lithiasis or gallbladder polyps
- Clinical, biological ou medical imaging history leading to suspicion of gallstones migration
- Absence of contra-indication to anesthesia and cholecystectomy procedure
- Ability to understand the study related information and to provide written informed consent
- Registered with the French social security regime
Show all 12Show fewer
- Non inclusion Criteria:
- Inability to give informed consent
- Acute Cholecystitis
- Contraindications to MRI exam (claustrophobia, implantable devices)
- Potential risk of allergic reactions to iodine-containing contrast agents, to indocyanine green or other fluorescent compounds
- Pregnancy or breast-feeding
Who cannot join
- Forfeit freedom from an administrative or legal obligation
- Under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, 67000
About this study
Official title: Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study
The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.
Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:
Read more
- ease of use
- lack of invasiveness
- absence of ionizing radiation to the patient and the operating staff
- performed prior to any dissection (prior to "critical view of safety")
Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.
The study requires a 2-month patient participation.
- Conditions
- Cholelithiasis, Gallbladder Polyps
- Being tested
- Fluorescence cholangiography (da Vinci surgical system), Virtual cholangiography, Conventional IOC
- Keywords
- Cholelithiasis, Gallbladder polyps, Fluorescence, Indocyanine green (ICG), Intraoperative cholangiography (IOC), da Vinci surgical system
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence cholangiography (da Vinci surgical system)Device
Also called da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision System
Patients will received IV injection of ICG intra-operatively, allowing surgeons to view bile ducts under fluorescence imaging using the da Vinci surgical system with fluorescence Imaging system.
Virtual cholangiographyOther
Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.
Conventional IOCProcedure or surgery
Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence/Virtual cholangiography/IOC | Experimental | Prior to cholecystectomy, patients will undergo:
* Fluorescence cholangiography (visualization following up to a maximum of 0.5 mg/kg ICG - usually 10 ml of 0,5 mg/ml solution)
* Virtual cholangiography (enhanced-reality) superimposed on fluorescence images
* Conventional IOC (intraoperative cholangiography) Receives: Device: Fluorescence cholangiography (da Vinci surgical system); Other: Virtual cholangiography; Procedure: Conventional IOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography
Percentage of patients for whom fluorescence allows for cysticocholedochal junction with precision at least as good as intraoperative cholangiography (identification of anatomical details and information).
Independent aposteriori evaluation performed by a radiologist/surgeon team.
Measured: Intra-operatively
Secondary outcomes (3)
To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy
Percentage of patients for whom fluorescence-based imaging allows correct identification of biliary tree anatomy (anatomical variant, cystic duct stones, bile duct stones, dilated ducts)
Measured: Intra-operatively
To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction
Percentage of patients for whom enhanced reality allows correct identification of biliary tree anatomy,especially the cysticocholedochal junction
Measured: Intra-operatively
To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography
Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute)
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
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 CholelithiasisStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Pessaux, Pr, Principal investigator, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881399
- Sponsor's protocol ID
- 12-004
- Other IDs
- 2012-A01664-39
- Acronym
- FLARIOC
- Status last verified
- Mar 2018
- First submitted
- 17 Jun 2013
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Diana M, Soler L, Agnus V, D'Urso A, Vix M, Dallemagne B, Faucher V, Roy C, Mutter D, Marescaux J, Pessaux P. Prospective Evaluation of Precision Multimodal Gallbladder Surgery Navigation: Virtual Reality, Near-infrared Fluorescence, and X-ray-based Intraoperative Cholangiography. Ann Surg. 2017 Nov;266(5):890-897. doi: 10.1097/SLA.0000000000002400.
PubMed 28742709
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study
- ClinicalTrials.gov ID
- NCT01881399
- Acronym / sponsor ID
- FLARIOC / 12-004
- Conditions
- Cholelithiasis, Gallbladder Polyps
- Keywords
- Cholelithiasis, Gallbladder polyps, Fluorescence, Indocyanine green (ICG), Intraoperative cholangiography (IOC), da Vinci surgical system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Jun 2013 (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.
The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.
Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:
- ease of use
- lack of invasiveness
- absence of ionizing radiation to the patient and the operating staff
- performed prior to any dissection (prior to "critical view of safety")
Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.
The study requires a 2-month patient participation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescence/Virtual cholangiography/IOC | Experimental | Device: Fluorescence cholangiography (da Vinci surgical system), Other: Virtual cholangiography, Procedure: Conventional IOCPrior to cholecystectomy, patients will undergo: * Fluorescence cholangiography (visualization following up to a maximum of 0.5 mg/kg ICG - usually 10 ml of 0,5 mg/ml solution) * Virtual cholangiography (enhanced-reality) superimposed on fluorescence images * Conventional IOC (intraoperative cholangiography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Man or woman > 18 years old
- Symptomatic gallbladder lithiasis or gallbladder polyps
- Clinical, biological ou medical imaging history leading to suspicion of gallstones migration
- Absence of contra-indication to anesthesia and cholecystectomy procedure
- Ability to understand the study related information and to provide written informed consent
Key exclusion criteria (2 listed)
- Forfeit freedom from an administrative or legal obligation
- Under guardianship
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 |
|---|---|---|
| Fluorescence cholangiography (da Vinci surgical system)Also: da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision SystemPatients will received IV injection of ICG intra-operatively, allowing surgeons to view bile ducts under fluorescence imaging using the da Vinci surgical system with fluorescence Imaging system. | Device | Fluorescence/Virtual cholangiography/IOC |
| Virtual cholangiographyImages from virtual cholangiography will be superimposed in real time on images obtained with fluorescence. | Other | Fluorescence/Virtual cholangiography/IOC |
| Conventional IOCPatients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging. | Procedure or surgery | Fluorescence/Virtual cholangiography/IOC |
Primary outcome
To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography
Time frame: Intra-operatively
Percentage of patients for whom fluorescence allows for cysticocholedochal junction with precision at least as good as intraoperative cholangiography (identification of anatomical details and information). Independent aposteriori evaluation performed by a radiologist/surgeon team.
3 secondary outcomes
To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy
Time frame: Intra-operatively
To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction
Time frame: Intra-operatively
To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography
Time frame: Intra-operatively
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 14 Mar 2018.
- Results publication: PubMed 28742709Diana M, Soler L, Agnus V, D'Urso A, Vix M, Dallemagne B, Faucher V, Roy C, Mutter D, Marescaux J, Pessaux P. Prospective Evaluation of Precision Multimodal Gallbladder Surgery Navigation: Virtual Reality, Near-infrared Fluorescence, and X-ray-based Intraoperative Cholangiography. Ann Surg. 2017 Nov;266(5):890-897. doi: 10.1097/SLA.0000000000002400.
Related trials for Cholelithiasis
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
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.
Patrick Pessaux, Pr principal investigator
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence cholangiography (da Vinci surgical system), Virtual cholangiography and Conventional IOC in people with Cholelithiasis and Gallbladder Polyps, run by IHU Strasbourg at 1 site in France.
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 12 inclusion and 2 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 14 Mar 2018. 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 France. 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?
To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography (time frame: Intra-operatively). 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 NCT01881399, 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 14 Mar 2018.