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

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Cholecystitis, Acute; Cholangiopathy; Lithiasis

Treatments: Diagnostic Test: systematic intraoperative cholangiography; Procedure: laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04103762

PI2017_843_0020

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

indocyanine green

Experimental group

Description:

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

Treatment:

Procedure: laparoscopic cholecystectomy

Diagnostic Test: systematic intraoperative cholangiography

standard cpo

Active Comparator group

Description:

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

Treatment:

Procedure: laparoscopic cholecystectomy

Diagnostic Test: systematic intraoperative cholangiography