CholecystitisNIRF-CNCT02070640
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
A study testing Injection of indocyanine green (ICG) and Near Infrared Cholangiography Fluorescence (NIRF-C) in people with Cholecystitis, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- Injection of indocyanine green (ICG) and Near Infrared Cholangiography Fluorescence (NIRF-C)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Planned laparoscopic cholecystectomy
Who cannot join
- Inability to provide informed consent
- Pregnant
- Allergy to ICG, iodine, and/or shellfish
- Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
- Lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43214
About this study
Official title: Near Infrared Fluorescence Cholangiography During Cholecystectomy
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.
Read the detailed description
This study is designed to determine the clinical utility of intravenous indocyanine green (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. Testing will be done during an abdominal surgery which requires gallbladder removal. Subjects will be recruited during consult for their surgical procedure. The study itself will take an estimated 5 minutes during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be given. Following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (IOC), which is standard of care. Subject post-operative recovery will be monitored for the duration of their hospital stay. Adverse events will be monitored at the patient's routine follow up visit.
- Conditions
- Cholecystitis
- Being tested
- Injection of indocyanine green (ICG), Near Infrared Cholangiography Fluorescence (NIRF-C)
- Keywords
- cholecystectomy, cholecystitis
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of indocyanine green (ICG)Drug
2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. 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)Device
Also called Stryker 1488 Camera System, Stryker L9000 Light Source, Stryker 1488 Coupler, Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)
These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
| Study group | Role | What they receive |
|---|---|---|
| NIRF-C | Experimental | Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera. Receives: Drug: Injection of indocyanine green (ICG); Device: Near Infrared Cholangiography Fluorescence (NIRF-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications Related to ICG
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.
Measured: From time of injection to 1st post-op follow-up
Secondary outcomes (2)
Incidence of Anatomic Identification With NIRF-C
Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.
Measured: Intraoperative
Time to Complete NIRF-C and IOC
The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments, Society of American Gastrointestinal and Endoscopic Surgeons
- Responsible party
- Principal investigator, Narula, Vimal K, MD, Ohio State University
- Investigators
- Vimal K Narula, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070640
- Sponsor's protocol ID
- 2011H0239
- Acronym
- NIRF-C
- Status last verified
- Sep 2015
- First submitted
- 21 Feb 2014
- Last updated
- 21 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Fluorescence Cholangiography During Cholecystectomy
- ClinicalTrials.gov ID
- NCT02070640
- Acronym / sponsor ID
- NIRF-C / 2011H0239
- Conditions
- Cholecystitis
- Keywords
- cholecystectomy, cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Stryker Instruments, Society of American Gastrointestinal and Endoscopic Surgeons
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Posted 21 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to determine the clinical utility of intravenous indocyanine green (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. Testing will be done during an abdominal surgery which requires gallbladder removal. Subjects will be recruited during consult for their surgical procedure. The study itself will take an estimated 5 minutes during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be given. Following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (IOC), which is standard of care. Subject post-operative recovery will be monitored for the duration of their hospital stay. Adverse events will be monitored at the patient's routine follow up visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRF-C | Experimental | Drug: Injection of indocyanine green (ICG), Device: Near Infrared Cholangiography Fluorescence (NIRF-C)Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-89
- Planned laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- Inability to provide informed consent
- Pregnant
- Allergy to ICG, iodine, and/or shellfish
- Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
- Lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of indocyanine green (ICG)2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. | Drug | NIRF-C |
| Near Infrared Cholangiography Fluorescence (NIRF-C)Also: Stryker 1488 Camera System, Stryker L9000 Light Source, Stryker 1488 Coupler, Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. | Device | NIRF-C |
Primary outcome
Complications Related to ICG
Time frame: 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.
2 secondary outcomes
Incidence of Anatomic Identification With NIRF-C
Time frame: Intraoperative
Time to Complete NIRF-C and IOC
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vimal K Narula, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of indocyanine green (ICG) and Near Infrared Cholangiography Fluorescence (NIRF-C) in people with Cholecystitis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications Related to ICG (time frame: From time of injection to 1st post-op follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.