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Comparing Head and Neck Endoscopy Procedures

A Feasibility Study Comparing Head And Neck Endoscopy Procedures In The Upright And Supine Positions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01181362
Enrollment
10
Registered
2010-08-13
Start date
2010-09-30
Completion date
2013-01-31
Last updated
2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparing Head And Neck Endoscopy in Healthy Patients

Keywords

Endoscopy, Head and Neck region, Scope

Brief summary

Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes defined on this volumetric information data set. However, target delineation also depends on disease seen endoscopically which may not be visible on CT. We are developing imaging and tracking technology to improve target delineation in Radiation Therapy (RT) planning for head & neck cancer using quantitative registration of 2D endoscopic information with CT data. Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery are obtained with the patient in the supine position. The accuracy of the registration will be improved if performed in the same position to prevent mobile soft tissue structures shifting between the upright and supine positions. Since therapy must be performed in the supine position, we intend to check the feasibility of performing endoscopy in the supine treatment position. We will compare and assess patient comfort and endoscopic sightlines during an endoscopy procedure in both the upright and supine positions.

Interventions

PROCEDUREEndoscopy

All patients will meet the physician at the Head and Neck centre at PMH, where they will have a topical anesthetic (lidocaine endotracheal aerosol, 10 mg/dose) sprayed into both nostrils. After allowing 5-10 minutes to let the anesthetic take effect, they will have an endoscopy procedure using a flexible scope inserted through the nostrils. The procedure will first be performed while patients are sitting up. During the procedure, patients will be asked to rate their discomfort on a 10-point scale. The endoscope will then be removed. After a short rest (15 minutes), the endoscopy procedure will be repeated with patients lying down. They will again be asked to rate their level of discomfort. After another short rest for recovery, they will meet with the physician to discuss both endoscopic procedures and to complete a questionnaire on discomfort, tolerance and acceptability

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Between 18-70 years of age. * Willing to give informed consent.

Exclusion criteria

* Allergy to topical anesthetic nasal spray (lidocaine). * Patients who currently have or have had head and neck cancer. * Currently pregnant or lactating; or serious co-morbid illness (e.g., cardiovascular, pulmonary). * Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol. * Concurrent illness, which prevents the subject from undergoing endoscopy. * Disorders of the nasal cavity e.g deviated septum

Design outcomes

Primary

MeasureTime frame
To compare and assess subject comfort and adequacy of endoscope sightlines during an endoscopy procedure in both the upright and supine positions.4 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026