N/A
Completed N=99
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
Source: ClinicalTrials.gov NCT02070640 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Complications Related to ICG — 0; 0 % of Participants with Complications
Summary
The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complications Related to ICG |
0; 0 | — |
| SECONDARY Incidence of Anatomic Identification With NIRF-C |
95.1; 33 | — |
| SECONDARY Time to Complete NIRF-C and IOC |
1.9; 1.08 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-89
- Planned laparoscopic cholecystectomy
Exclusion Criteria
- Inability to provide informed consent
- Pregnant
- Allergy to ICG, iodine, and/or shellfish
- Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
- Lactating
Data sourced from ClinicalTrials.gov (NCT02070640). 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. Informational only — not medical advice.