N/A
N=677
Fluorescent Cholangiography vs White Light for Bile Ducts Identification
Cholecystitis · Cholelithiasis
Bottom Line
View on ClinicalTrials.gov: NCT02702843 ↗Enrolled (actual)
677
Serious AEs
0.3%
Results posted
Nov 2025
Primary outcome: Primary: Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light — 64; 157; 159; 243 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laparoscopic cholecystectomy with Xenon light (Procedure); Laparoscopic cholecystectomy (fluorescent cholangiography) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light |
64; 157; 159; 243 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02702843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.