LithiasisVIFCALNCT04103762
Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis
A study testing laparoscopic cholecystectomy and systematic intraoperative cholangiography in people with Lithiasis and Cholecystitis, Acute, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Acute lithiasis cholecystitis (ALC) is the third most common cause of surgical emergency admission. The initial treatment of ALC associates a medical support and a cholecystectomy, preferentially performed laparoscopically in the first 5 days of evolution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lithiasis, Cholecystitis, Acute, Cholangiopathy
- What is being tested?
- laparoscopic cholecystectomy and systematic intraoperative cholangiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 9 Jul 2024
- 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
- Adults patient (>18 years old)
- Patients requiring laparoscopic cholecystectomy for grade 1 or 2 acute gallstone cholecystitis according to Tokyo recommendations confirmed by radiological morphological examination
- Acute lithiasis cholecystitis (ALC) evolving for less than 5 days
- Patients affiliated to a social security scheme
Who cannot join
- Antecedent of biliary tract surgery
- Antecedent of cholecystectomy
- Contraindication to laparoscopy
- Contraindication to surgery
- Cholecystectomy by laparotomy out of hand
- Grade 3 cholecystitis according to Tokyo recommendations
Show all 13Show fewer
- Acute alithiasis cholecystitis
- Cirrhosis
- Conversion for gangrenous ALC
- Patient with an allergy to indocyanine green
- Pregnant or lactating woman, childbearing age without effective contraception
- Minor patient
- Physical or psychological state that does not allow participation in the study, patient under guardianship or curatorship or patient deprived of liberty by a judicial or administrative decision (according with articles L 1121-6 and L 1121-8 of the French Public Health Code)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Intravenous Cholangiography With Indocyanine Green, Compared to Contrast Cholangiography, in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis: Prospective, Monocentric, Randomized Study
Acute lithiasis cholecystitis (ALC) is the third most common cause of surgical emergency admission. The initial treatment of ALC associates a medical support and a cholecystectomy, preferentially performed laparoscopically in the first 5 days of evolution. During the surgery, intraoperative cholangiography (CPO) using a contrast product is the "gold standard" to identify the bile ducts. However CPO is performed in approximately 30% of laparoscopic cholecystectomy.
Laparoscopic cholecystectomy for ALC is associated with an increase in the rate of biliary ducts injuries compared with cholecystectomy for symptomatic vesicular lithiasis, evaluated at 0.8 % versus 0.1 %. Its higher rate is related to local inflammation that alters the biliary anatomy and complicates the identification of the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.
- Conditions
- Lithiasis, Cholecystitis, Acute, Cholangiopathy
- Being tested
- laparoscopic cholecystectomy, systematic intraoperative cholangiography
- Keywords
- acute lithiasis cholecystitis, intraoperative cholangiography, indocyanine green, cholecystectomy
- Medical subject headings
- Lithiasis, Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyProcedure or surgery
laparoscopic cholecystectomy
systematic intraoperative cholangiographyDiagnostic test
systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)
| Study group | Role | What they receive |
|---|---|---|
| indocyanine green | Experimental | During the surgery, intraoperative cholangiography using indocyanine green will be performed Receives: Procedure: laparoscopic cholecystectomy; Diagnostic Test: systematic intraoperative cholangiography |
| standard cpo | Active comparator | During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed Receives: Procedure: laparoscopic cholecystectomy; Diagnostic Test: systematic intraoperative cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of surgical procedure after Indocyanine green injection
Change of surgical procedure after Indocyanine green injection compared to intraoperative cholangiography (CPO) using a contrast product as the "gold standard" to identify the bile ducts.
Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.
Measured: day 0 = the day of the surgery
Secondary outcomes (3)
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
Measured: day 0 = the day of the surgery
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
Measured: day 0 = the day of the surgery
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
Measured: day 0 = the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2021
- Study completion9 Jul 2024
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 LithiasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama ABOU ARAB, MD, Principal investigator, CHU AmiensEmilie Dumange Chapuis-Roux, MD, Principal investigator, CHU AmiensRalucar Macovei, MD, Principal investigator, CHU AmiensBaptiste Brac, MD, Principal investigator, CHU AmiensAurélien Gracient, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103762
- Sponsor's protocol ID
- PI2017_843_0020
- Acronym
- VIFCAL
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Defives H, Chive E, Diouf M, Ammar-Khodja N, Pellegrin A, Werey F, Yvart-Degardin J, Sabbagh C, Regimbeau JM. Value of intravenous cholangiography with indocyanine green during laparoscopic cholecystectomy for grade I or II acute lithiasic cholecystitis: Results of a prospective, open, randomized, monocentric study (VIFCAL trial). Curr Probl Surg. 2025 Aug;69:101788. doi: 10.1016/j.cpsurg.2025.101788. Epub 2025 May 2. No abstract available.
PubMed 40716885
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Intravenous Cholangiography With Indocyanine Green, Compared to Contrast Cholangiography, in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis: Prospective, Monocentric, Randomized Study
- ClinicalTrials.gov ID
- NCT04103762
- Acronym / sponsor ID
- VIFCAL / PI2017_843_0020
- Conditions
- Lithiasis, Cholecystitis, Acute, Cholangiopathy
- Keywords
- acute lithiasis cholecystitis, intraoperative cholangiography, indocyanine green, cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 25 Sep 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.
Acute lithiasis cholecystitis (ALC) is the third most common cause of surgical emergency admission. The initial treatment of ALC associates a medical support and a cholecystectomy, preferentially performed laparoscopically in the first 5 days of evolution. During the surgery, intraoperative cholangiography (CPO) using a contrast product is the "gold standard" to identify the bile ducts. However CPO is performed in approximately 30% of laparoscopic cholecystectomy.
Laparoscopic cholecystectomy for ALC is associated with an increase in the rate of biliary ducts injuries compared with cholecystectomy for symptomatic vesicular lithiasis, evaluated at 0.8 % versus 0.1 %. Its higher rate is related to local inflammation that alters the biliary anatomy and complicates the identification of the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indocyanine green | Experimental | Procedure: laparoscopic cholecystectomy, Diagnostic Test: systematic intraoperative cholangiographyDuring the surgery, intraoperative cholangiography using indocyanine green will be performed |
| standard cpo | Active comparator | Procedure: laparoscopic cholecystectomy, Diagnostic Test: systematic intraoperative cholangiographyDuring the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults patient (>18 years old)
- Patients requiring laparoscopic cholecystectomy for grade 1 or 2 acute gallstone cholecystitis according to Tokyo recommendations confirmed by radiological morphological examination
- Acute lithiasis cholecystitis (ALC) evolving for less than 5 days
- Patients affiliated to a social security scheme
Key exclusion criteria (13 listed)
- Antecedent of biliary tract surgery
- Antecedent of cholecystectomy
- Contraindication to laparoscopy
- Contraindication to surgery
- Cholecystectomy by laparotomy out of hand
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 |
|---|---|---|
| laparoscopic cholecystectomylaparoscopic cholecystectomy | Procedure or surgery | indocyanine green, standard cpo |
| systematic intraoperative cholangiographysystematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group) | Diagnostic test | indocyanine green, standard cpo |
Primary outcome
Change of surgical procedure after Indocyanine green injection
Time frame: day 0 = the day of the surgery
Change of surgical procedure after Indocyanine green injection compared to intraoperative cholangiography (CPO) using a contrast product as the "gold standard" to identify the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.
3 secondary outcomes
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
Time frame: day 0 = the day of the surgery
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
Time frame: day 0 = the day of the surgery
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
Time frame: day 0 = the day of the surgery
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 19 Sep 2025.
- Results publication: PubMed 40716885Defives H, Chive E, Diouf M, Ammar-Khodja N, Pellegrin A, Werey F, Yvart-Degardin J, Sabbagh C, Regimbeau JM. Value of intravenous cholangiography with indocyanine green during laparoscopic cholecystectomy for grade I or II acute lithiasic cholecystitis: Results of a prospective, open, randomized, monocentric study (VIFCAL trial). Curr Probl Surg. 2025 Aug;69:101788. doi: 10.1016/j.cpsurg.2025.101788. Epub 2025 May 2. No abstract available.
- Individual participant dataSharing planned: No
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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.
Osama ABOU ARAB, MD principal investigator
CHU Amiens
Emilie Dumange Chapuis-Roux, MD principal investigator
CHU Amiens
Ralucar Macovei, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic cholecystectomy and systematic intraoperative cholangiography in people with Lithiasis and Cholecystitis, Acute, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 13 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 19 Sep 2025. 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?
Change of surgical procedure after Indocyanine green injection (time frame: day 0 = the day of the surgery). 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 NCT04103762, 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 19 Sep 2025.