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

Dartmouth Health

Status: Completed

Conditions: Oropharyngeal Cancer

Treatments: Other: Intraoperative CT imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02405000

D14189

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Intraoperative CT imaging

Experimental group

Treatment:

Other: Intraoperative CT imaging