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

Oropharyngeal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405000
• Other study ID #: D14189
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: October 24, 2017

Study information

• Verified date: April 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 24, 2017
• Est. primary completion date: October 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Other:
• Intraoperative CT imaging
Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy		Collected at the time of surgery