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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lithiasis, Cholecystitis, Acute, Cholangiopathy

Intervention / Treatment
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* Procedure: laparoscopic cholecystectomy
* Diagnostic Test: systematic intraoperative cholangiography


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: indocyanine green<br>During the surgery, intraoperative cholangiography using indocyanine green will be performed | Procedure: laparoscopic cholecystectomy<br>* laparoscopic cholecystectomy<br>Diagnostic Test: systematic intraoperative cholangiography<br>* systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)<br>|
| Active Comparator: standard cpo<br>During the surgery, intraoperative cholangiography using a contrast product gold standard will be performed | Procedure: laparoscopic cholecystectomy<br>* laparoscopic cholecystectomy<br>Diagnostic Test: systematic intraoperative cholangiography<br>* systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute lithiasis cholecystitis, intraoperative cholangiography, indocyanine green, cholecystectomy