N/A N=99 Diagnostic

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

Cholecystitis

Bottom Line

View on ClinicalTrials.gov: NCT02070640 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2015

Primary outcome: Primary: Complications Related to ICG — 0; 0 % of Participants with Complications

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Injection of indocyanine green (ICG) (Drug); Near Infrared Cholangiography Fluorescence (NIRF-C) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio State University
Primary completion: Aug 2014

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	—

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.

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

View full record on ClinicalTrials.gov →

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.