Trial Outcomes & Findings for Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy (NCT NCT02070640)

Results Overview

A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

99 participants

Primary outcome timeframe

From time of injection to 1st post-op follow-up

Results posted on

2015-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Non-acute Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.	Acute Cholecystitis Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
Overall Study STARTED	93	6
Overall Study COMPLETED	82	6
Overall Study NOT COMPLETED	11	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Acute n=82 Participants Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.	Acute Cholecystitis n=6 Participants Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants	6 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	3 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	3 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	6 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: From time of injection to 1st post-op follow-up

A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.

Outcome measures

Outcome measures
Measure	Non-Acute n=82 Participants Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.	Acute Cholecystitis n=6 Participants Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
Complications Related to ICG	0 % of Participants with Complications	0 % of Participants with Complications

SECONDARY outcome

Timeframe: Intraoperative

Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.

Outcome measures

Outcome measures
Measure	Non-Acute n=82 Participants Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.	Acute Cholecystitis n=6 Participants Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
Incidence of Anatomic Identification With NIRF-C	95.1 percentage of biliary anatomy observatio	33 percentage of biliary anatomy observatio

SECONDARY outcome

Timeframe: Intraoperative

The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.

Outcome measures

Outcome measures
Measure	Non-Acute n=82 Participants Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.	Acute Cholecystitis n=6 Participants Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
Time to Complete NIRF-C and IOC	1.9 minutes Interval 0.2 to 3.6	1.08 minutes Interval 0.25 to 1.28

Adverse Events

Non-acute

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Acute Cholecystitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Non-acute n=93 participants at risk Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.	Acute Cholecystitis n=6 participants at risk Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
Infections and infestations IV infiltration of ICG	1.1% 1/93 • Number of events 1 • 1 month	0.00% 0/6 • 1 month

Additional Information

Associate Professor

The Ohio State University Wexner Medical Center

Phone: 614-293-3230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place