Brief Title
Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis
Official Title
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
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.
Study Type
Interventional
Primary Outcome
Change of surgical procedure after Indocyanine green injection
Secondary Outcome
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
Condition
Lithiasis
Intervention
laparoscopic cholecystectomy
Study Arms / Comparison Groups
indocyanine green
Description: During the surgery, intraoperative cholangiography using indocyanine green will be performed
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
128
Start Date
October 2019
Completion Date
November 2021
Primary Completion Date
October 2021
Eligibility Criteria
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
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Osama ABOU ARAB, MD, (33)322088893, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04103762
Organization ID
PI2017_843_0020
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire, Amiens
Study Sponsor
Osama ABOU ARAB, MD, Principal Investigator, CHU Amiens
Verification Date
September 2019