Back to resultsICG Use in Angiography for Nasoseptal Flap Harvest (ICG)
Primary Purpose
Skull Base Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
indocyanine green
Sponsored by
About this trial
This is an interventional diagnostic trial for Skull Base Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Age 18 and above
- Patients undergoing an EEA for cranial base pathology that may require nasoseptal flap harvest
Exclusion Criteria:
- History of sulfa, iodide, or penicillin allergy
- Pregnant or breast feeding
- Preoperative lack of indication for nasoseptal flap harvest
- Previous anaphylactic reaction to ICG
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICG
Arm Description
Angiography with administered ICG
Outcomes
Primary Outcome Measures
Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.
The researcher will administer ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case. This study will determine feasibility of other larger clinical trials using this method.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02117310
Brief Title
ICG Use in Angiography for Nasoseptal Flap Harvest
Acronym
ICG
Official Title
Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Sphenopalatine Artery Location and Patency in Harvesting and Positioning a Pedicled Nasoseptal Mucosal Flap in Endoscopic Endonasal Cranial Base Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a feasibility study in which indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal flap harvest will be necessary. The research entails administering ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
Detailed Description
This study is being done to determine if it is feasible to use angiography during endo-nasal surgery. During the angiography indocyanine green (ICG) will be injected into the patients IV tubing to help see the arteries. ICG is routinely used in vascular surgeries on the brain but not for endo-nasal surgery. The purpose of this study is to see how well intraoperative angiography using ICG can be done during endonasal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skull Base Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICG
Arm Type
Experimental
Arm Description
Angiography with administered ICG
Intervention Type
Drug
Intervention Name(s)
indocyanine green
Intervention Description
ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
Primary Outcome Measure Information:
Title
Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.
Description
The researcher will administer ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case. This study will determine feasibility of other larger clinical trials using this method.
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 and above
Patients undergoing an EEA for cranial base pathology that may require nasoseptal flap harvest
Exclusion Criteria:
History of sulfa, iodide, or penicillin allergy
Pregnant or breast feeding
Preoperative lack of indication for nasoseptal flap harvest
Previous anaphylactic reaction to ICG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Prevedello, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ICG Use in Angiography for Nasoseptal Flap Harvest
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