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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2021

Interventions

  • Procedure: laparoscopic cholecystectomy
    • laparoscopic cholecystectomy
  • Diagnostic Test: systematic intraoperative cholangiography
    • systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)

Arms, Groups and Cohorts

  • Experimental: indocyanine green
    • During the surgery, intraoperative cholangiography using indocyanine green will be performed
  • Active Comparator: standard cpo
    • During the surgery, intraoperative cholangiography using a contrast product “gold standard” will be performed

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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 CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
  • 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 before 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
    • Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire, Amiens
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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
    • AurĂ©lien Gracient, MD, Principal Investigator, CHU Amiens
  • Overall Contact(s)
    • Jean-Marc Regimbeau, Pr, (33)322088893, regimbeau.jean.marc@chu-amiens.fr

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