Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02070627

Acronym

NIRF-C Acute

Enrollment

Registered

2014-02-25

Start date

2013-07-31

Completion date

2014-08-31

Last updated

2014-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholangitis, Acute Cholecystitis

Keywords

acute cholecystitis, acute cholangitis, cholecystectomy

Brief 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) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Interventions

DRUGIndocyanine Green (ICG)

60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging.

DEVICENear Infrared Fluorescence Cholangiography (NIRF-C)

Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

* Age 18-89 * Planned laparoscopic cholecystectomy

Exclusion criteria

* Inability to provide informed consent * Pregnant * Allergy to ICG, iodine, and/or shellfish * Lactating

Design outcomes

Primary

Measure	Time frame	Description
Adverse events related to use of indocyanine green (ICG)	Injection to 2 wk follow-up	Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed.
Anatomic identification with NIRF-C and IOC	Intraoperative	Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality.
Procedure time	Intraoperative	The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026