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

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source 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.

Overall Status Not yet recruiting
Start Date October 2019
Completion Date November 2021
Primary Completion Date October 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change of surgical procedure after Indocyanine green injection day 0 = the day of the surgery
Secondary Outcome
Measure Time Frame
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 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 day 0 = the day of the surgery
Enrollment 128
Condition
Intervention

Intervention Type: Procedure

Intervention Name: laparoscopic cholecystectomy

Description: laparoscopic cholecystectomy

Intervention Type: Diagnostic Test

Intervention Name: systematic intraoperative cholangiography

Description: systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)

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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Jean-Marc Regimbeau, Pr

Phone: (33)322088893

Email: [email protected]

Location
Facility: Contact: CHU Amiens Jean-Marc Regimbeau, Pr (33)322088893 [email protected]
Location Countries

France

Verification Date

September 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: indocyanine green

Type: Experimental

Description: During the surgery, intraoperative cholangiography using indocyanine green will be performed

Label: standard cpo

Type: Active Comparator

Description: During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed

Acronym VIFCAL
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov