Fluorescent Cholangiography vs White Light for Bile Ducts Identification

Completed · Not applicable

Conditions studied: Cholecystitis, Cholelithiasis

In brief

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).

Key facts

Study ID

NCT02702843

Run by

The Cleveland Clinic

People needed

677

Starts

2016-04-01

Expected to finish

2018-08-31

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of both genders
• Minimum age: 18 years old
• Spoken and written command of the language spoken in the country's center
• Ability to understand and follow the study procedures and sign the informed consent

You may not qualify if…

• Known allergies to iodides
• Known history of coagulopathy
• Known moderate or severe liver disease Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out

Where it is running

• Cedar Sinai — Los Angeles, California, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Hospital de clinicas jose de San Martin — Buenos Aires, Argentina
• Askelopios Westklinikum Hamburg — Hamburg, Germany
• Klinikum Sudstadt Rostock — Rostock, Germany
• University of Insubria — Varese, Italy
• University of Tokyo — Tokyo, Japan

Full record on ClinicalTrials.gov

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