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

Usefulness of the Valsalva maneuver with a specific mouthpiece to observe the hypopharynx during transoral endoscopy. - Valsalva Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033274

Enrollment

Registered

2018-07-04

Start date

2018-07-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hypopharyngeal cancer

Interventions

Observe oropharynx using transoral endoscop with a specific mouthpiece for Valsalva maneuver first and subsequently with a conventional mouthpiece. Observe oropharynx using transoral endoscopy with a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients aged 20 years or older with esophageal squamous cell carcinoma (ESCC) before or under treatment, or with a history of ESCC. 2.Patients who are scheduled to undergo transoral upper gastrointestinal endoscopy.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactYoshito Hayashi

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology

y.hayashi@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026