UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of the Valsalva maneuver with a specific mouthpiece to observe the hypopharynx during transoral endoscopy.
Acronym	Valsalva Study
Scientific Title	Usefulness of the Valsalva maneuver with a specific mouthpiece to observe the hypopharynx during transoral endoscopy.
Scientific Title:Acronym	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	1st name Tetsuo Middle name Last name Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
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	1st name Yoshito Middle name Last name Hayashi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
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)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committe
Address	2-2 Yamadaoka Suita, Osaka,Japan.
Tel	06-6210-8296
Email	handai-nintei@hc-crc.med.osaka-u.ac.jp

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

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	35
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 12 Day
Date of IRB	2018 Year 07 Month 12 Day
Anticipated trial start date	2018 Year 07 Month 20 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 04 Day
Last modified on	2020 Year 05 Month 17 Day

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