Clinical trial NCT04103762: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lithiasis
Cholecystitis, Acute
Cholangiopathy
Keywords: acute lithiasis cholecystitis
intraoperative cholangiography
indocyanine green
cholecystectomy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change of surgical procedure after Indocyanine green injection
timeFrame: day 0 = the day of the surgery
Secondary outcomes:
measure: Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
timeFrame: day 0 = the day of the surgery
measure: Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
timeFrame: day 0 = the day of the surgery
measure: Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
timeFrame: day 0 = the day of the surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Osama ABOU ARAB, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Emilie Dumange Chapuis-Roux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Ralucar Macovei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Baptiste Brac, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Aurélien Gracient, MD
role: PRINCIPAL_INVESTIGATOR
References: