ICG Use in Angiography for Nasoseptal Flap Harvest

Not Applicable

Completed

• Conditions: Skull Base Neoplasms
• Interventions: Drug: indocyanine green

• Registration Number: NCT02117310
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Study Start: 2015-03
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-03
• Results First Submitted: 2017-03-01
• Results First Submitted QC: 2017-04-13
• Last Update Submitted: 2017-04-13
• Results First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG	indocyanine green	Angiography with administered ICG

Primary Outcome Measures

Name	Time	Method
Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.	During 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.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States