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

NCT04103762 | Completed

• 1 other identifier: PI2017_843_0020
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lithiasis; Cholecystitis, Acute; Cholangiopathy

Keywords

acute lithiasis cholecystitis; intraoperative cholangiography; indocyanine green; cholecystectomy

Outcome Measures

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.

  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

  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

  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

  day 0 = the day of the surgery

Study Arms (2)

indocyanine green

EXPERIMENTAL

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

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

Procedure: laparoscopic cholecystectomy; Diagnostic Test: systematic intraoperative cholangiography

Interventions

laparoscopic cholecystectomy PROCEDURE

laparoscopic cholecystectomy

indocyanine green; standard cpo

systematic intraoperative cholangiography DIAGNOSTIC_TEST

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

indocyanine green; standard cpo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Related Publications (1)

• 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.

  PMID: 40716885 RESULT

MeSH Terms

Conditions

Lithiasis; Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Osama ABOU ARAB, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Emilie Dumange Chapuis-Roux, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Ralucar Macovei, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Baptiste Brac, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Aurélien Gracient, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 25, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: July 9, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)