UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033274 |
|---|---|
| Receipt number | R000037935 |
| Scientific Title | 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 | 2020/05/17 15:30:35 |
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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
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
y.hayashi@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037935
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
