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CompletedNCT04103762VIFCALUpdated Sep 19, 2025

Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis

An interventional study of laparoscopic cholecystectomy and systematic intraoperative cholangiography in Lithiasis, Cholecystitis, Acute and Cholangiopathy, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Lithiasis
  • Cholecystitis, Acute
  • Cholangiopathy

Keywords

  • acute lithiasis cholecystitis
  • intraoperative cholangiography
  • indocyanine green
  • cholecystectomy
03

In context

Lithiasis

11 studies on the registry are indexed under Lithiasis; 2 are open to participants now.

Browse Lithiasis studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Antecedent of biliary tract surgery
  • Antecedent of cholecystectomy
  • to laparoscopy
  • Contraindication to surgery
  • Cholecystectomy by laparotomy out of hand
  • Grade 3 cholecystitis according to Tokyo recommendations
  • Acute alithiasis cholecystitis
  • Cirrhosis
  • Conversion for gangrenous ALC
  • Patient with an allergy to indocyanine green
  • Pregnant or lactating woman, childbearing age without effective
  • 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    indocyanine green

    During the surgery, intraoperative cholangiography using indocyanine green will be performed

    Procedure: laparoscopic cholecystectomy · Diagnostic Test: systematic intraoperative cholangiography

  • Active comparator
    standard cpo

    During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed

    Procedure: laparoscopic cholecystectomy · Diagnostic Test: systematic intraoperative cholangiography

Interventions

  • Procedurelaparoscopic cholecystectomy

    laparoscopic cholecystectomy

  • Diagnostic testsystematic intraoperative cholangiography

    systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 0 = the day of the surgery

Secondary outcomes

  1. 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

    Time frame: day 0 = the day of the surgery

  2. 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

    Time frame: day 0 = the day of the surgery

  3. 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

    Time frame: day 0 = the day of the surgery

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80480, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04103762
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Oct 1, 2019
Primary completion
Oct 1, 2021
Completion
Jul 9, 2024
Last update
Sep 19, 2025

Study contacts

Osama ABOU ARAB, MD
principal investigator · CHU Amiens
Emilie Dumange Chapuis-Roux, MD
principal investigator · CHU Amiens
Ralucar Macovei, MD
principal investigator · CHU Amiens
Baptiste Brac, MD
principal investigator · CHU Amiens
Aurélien Gracient, MD
principal investigator · CHU Amiens

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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