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

Cholecystitis, Acute Clinical Trial

— VIFCAL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04103762
• Other study ID #: PI2017_843_0020
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 2031

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Jean-Marc Regimbeau, Pr
• Phone: (33)322088893
• Email: regimbeau.jean.marc[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 2031
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cholangiopathy
• Cholecystitis
• Cholecystitis, Acute
• Gallstones
• Lithiasis

Intervention

Procedure:
• laparoscopic cholecystectomy
laparoscopic cholecystectomy

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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