Cholangiopathy, Cholecystitis, Acute, Lithiasis
Conditions
Keywords
acute lithiasis cholecystitis, intraoperative cholangiography, indocyanine green, cholecystectomy
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.
Interventions
PROCEDURElaparoscopic cholecystectomy
laparoscopic cholecystectomy
DIAGNOSTIC_TESTsystematic intraoperative cholangiography
systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
France
Outcome results
None listed