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

Not Applicable

Completed

• Conditions: Cholecystitis, Acute; Cholangiopathy; Lithiasis
• Interventions: Procedure: laparoscopic cholecystectomy; Diagnostic Test: systematic intraoperative cholangiography

• Registration Number: NCT04103762
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Study Start: 2019-10-01
• Primary Completion: 2021-10-01
• Status Verified: 2024-07
• Study Completion: 2024-07-09
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
indocyanine green	laparoscopic cholecystectomy	During the surgery, intraoperative cholangiography using indocyanine green will be performed
standard cpo	laparoscopic cholecystectomy	During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed
indocyanine green	systematic intraoperative cholangiography	During the surgery, intraoperative cholangiography using indocyanine green will be performed
standard cpo	systematic intraoperative cholangiography	During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed

Primary Outcome Measures

Name	Time	Method
Change of surgical procedure after Indocyanine green injection	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 Outcome Measures

Name	Time	Method
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 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 after 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
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 before dissection

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France