NCT04103762

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lithiasis
• Cholecystitis, Acute
• Cholangiopathy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-10-01
• Completion: 2024-07-09
• First posted: 2019-09-25
• Last updated: 2025-09-19

Locations

1 site across 1 country: France