Efficacy Of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) During Laparoscopic Cholecystectomy

NCT02702843 NA COMPLETED Results posted

The Study is designed to compare the effectiveness of Near Infrared Fluorescence Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory Ducts) during laparoscopic cholecystectomy. The aim is to demonstrate that NIFC performs better than standard white light (WLI) alone in visualizing and identifying extra-hepatobiliary structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts) before and after dissection during Laparoscopic Cholecystectomy (LC).

Details

Lead sponsor	The Cleveland Clinic
Phase	NA
Status	COMPLETED
Enrolment	677
Start date	2016-04
Completion	2018-08-31

Conditions

• Cholecystitis
• Cholelithiasis

Interventions

• Laparoscopic cholecystectomy with Xenon light
• Laparoscopic cholecystectomy (fluorescent cholangiography)

Primary outcomes

• Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light — Immediately before dissection (baseline) and immediately after dissection during the same surgical procedure.
  Detection rate of the common bile duct during laparoscopic cholecystectomy, defined as the proportion of patients in whom the common bile duct was visualized immediately before dissection (baseline) and immediately after dissection using near infrared light. The detection rate was calculated separately for each arm and reported as the percentage of patients with successful identification.

Countries

United States, Argentina, Germany, Italy, Japan