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Comparing Head and Neck Endoscopy Procedures

This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01181362
First received: August 12, 2010
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Comparing Head And Neck Endoscopy in Healthy Patients
 Procedure: Endoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Feasibility Study Comparing Head And Neck Endoscopy Procedures In The Upright And Supine Positions

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To compare and assess subject comfort and adequacy of endoscope sightlines during an endoscopy procedure in both the upright and supine positions. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Endoscopy Procedure: Endoscopy
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181362

Contacts
Contact: John Cho, MD 416 946 4501 ext 2124 john.cho@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: John Cho, MD     416 946 4501 ext 2124     john.cho@rmp.uhn.on.ca    
Principal Investigator: John Cho, MD            
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: John Cho, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01181362     History of Changes
Other Study ID Numbers: 09-0886-AE
Study First Received: August 12, 2010
Last Updated: December 17, 2012
Health Authority: Canada: Review Ethics Committee

Keywords provided by University Health Network, Toronto:
Endoscopy
Head and Neck region
Scope

ClinicalTrials.gov processed this record on May 21, 2013