sefulness of the Valsalva maneuver with a specific mouthpiece to observe the hypopharynx during transoral endoscopy.

Not Applicable

• Conditions: Hypopharyngeal cancer

• Registration Number: JPRN-UMIN000033274
• Lead Sponsor: Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-04
• Study Completion: 2019-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who have any contraindication to Valsalva maneuver (i.e., aortic stenosis, recent myocardial infarction within a year, retinopathy). 2.Patients with advanced head and neck cancer. 3.Patients who have been received endoscopic resection, surgery, or chemoradiotherapy for head and neck cancer. 4.Patients with a dementia or a severe psychiatric disorder. 5.Patients with a severe auditory impairment. 6.Patients who have an allergy to lidocaine or amide type local anesthetic. 7.Patients who have an allergy or any contraindication to pethidine hydrochloride. 8.Patients who cannot hold a mouthpiece in their mouth because of their impaired mouth opening, or dental diseases. 9.Patients judged to be ineligible by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of the perfect observation score (2 points) of hypopharynx (evaluated by physicians blinded to the allocations).

Secondary Outcome Measures

Name	Time	Method
1. Observation score of the hypopharynx (evaluated by the examiner). 2. Observation score of the oropharynx. 3. Pharyngeal observation time. 4. Newly detected oropharyngeal lesion. 5. Adverse events.