NCT02070627

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Cholecystitis
• Acute Cholangitis

Interventions

Type	Name	Description
DRUG	Indocyanine 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.
DEVICE	Near Infrared Fluorescence Cholangiography (NIRF-C)	Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-02-25
• Last updated: 2014-11-03

Locations

1 site across 1 country: United States