Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance

Not Applicable

Completed

• Conditions: Oropharyngeal Cancer
• Interventions: Other: Intraoperative CT imaging

• Registration Number: NCT02405000
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

The objective of this research is to perform a pilot study on patients undergoing laryngoscopy for diagnostic and tumor staging purposes (for pharyngeal or laryngeal cancer) in which intraoperative CT imaging will be performed both prior to (but after induction of general endotracheal anesthesia) and during placement of the laryngoscope in order to better understand anatomic changes that occur during instrumentation of the oral cavity and oropharynx. The goals of the study are:

1. Develop a suite of de-identified images and surface renderings that qualitatively show how a tumor and the upper aerodigestive tract anatomy deform during a laryngoscopic evaluation.

2. Create deformation models of the upper aerodigestive tract.

This data to be used for future retractor development as well as for virtual image guided surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-03-31
• Study Start: 2015-04
• Study First Posted: 2015-04-01
• Primary Completion: 2017-10-24
• Study Completion: 2017-10-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Adult patients (>18 years) seen in the Head and Neck Tumor Clinic who will require laryngoscopy in the operating room for diagnosis and staging of known or suspected tumors of the upper aerodigestive tract.

Exclusion Criteria

• Patients who are unable to tolerate general anesthesia.
• Patients who are felt to be a "difficult airway" for induction of general endotracheal anesthesia.
• Patients with excessive dental restorations and amalgam.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative CT imaging	Intraoperative CT imaging	-

Primary Outcome Measures

Name	Time	Method
Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy	Collected at the time of surgery

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States