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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033274
Receipt No. R000037935
Official scientific title of the study Usefulness of the Valsalva maneuver with a specific mouthpiece to observe the hypopharynx during transoral endoscopy.
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/12

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Basic information
Official scientific title of the study Usefulness of the Valsalva maneuver with a specific mouthpiece to observe the hypopharynx during transoral endoscopy.
Title of the study (Brief title) Valsalva Study
Region
Japan

Condition
Condition Hypopharyngeal cancer
Classification by specialty
Gastroenterology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of the Valsalva maneuver with a specific mouthpiece to observe the hypopharynx during transoral endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of the perfect observation score (2 points) of hypopharynx (evaluated by physicians blinded to the allocations).
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Observe oropharynx using transoral endoscop with a specific mouthpiece for Valsalva maneuver first and subsequently with a conventional mouthpiece.
Interventions/Control_2 Observe oropharynx using transoral endoscopy with a conventional mouthpiece first and subsequently with a specific mouthpiece for Valsalva maneuver.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 35

Research contact person
Name of lead principal investigator Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Address 2-2 Yamadaoka Suita, Osaka,Japan.
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person Yoshito Hayashi
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Address 2-2 Yamadaoka Suita, Osaka,Japan.
TEL 06-6879-3621
Homepage URL http://www.med.osaka-u.ac.jp/pub/gh/research_jisyu.html
Email y.hayashi@gh.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 04 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 12 Day
Anticipated trial start date
2018 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037935

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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