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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046572
Receipt No. R000053134
Scientific Title High-resolution manometry with additional maneuvers using the Starlet system : normative thresholds and diagnostic yields for relevant disorders of esophagogastric junction outflow
Date of disclosure of the study information 2022/01/07
Last modified on 2022/01/07

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Basic information
Public title Normative thresholds for upright high resolution manometry metrics and their diagnostic performances
Acronym Upright high resolution manometry
Scientific Title High-resolution manometry with additional maneuvers using the Starlet system : normative thresholds and diagnostic yields for relevant disorders of esophagogastric junction outflow
Scientific Title:Acronym High-resolution manometry with additional maneuvers using the Starlet system
Region
Japan

Condition
Condition healthy volunteer
esophageal motility disorders
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate normative thresholds for additional metrics on High-resolution manometry (HRM) using the Starlet system
Basic objectives2 Others
Basic objectives -Others to investigate diagnostic yields of new metrics for relevant motility disorders in patients with dysphagia or non-cardiac chest pain (NCCP)
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes normative thresholds for additional HRM metrics (i.e., upright IRP, upright IBP, IRP during rapid drink challenge)
Key secondary outcomes sensitivity and specificity of these metrcis for a diagnosis of relevant disorders of esophagogastric junction outflow

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Eligibility criteria for HV were that (i) 20<=age<=65, (ii) no medication which could have effect on gastrointestinal (GI) motility and gastric acid secretion in the last 1 month, (iii) no severe comorbidities (such as heart diseases or cancers).
Key exclusion criteria Exclusion criteria for participants in both studies were (i) allergy for xylocaine, (ii) pregnant or lactating, (iii) low quality tracings due to poor tolerability or artefacts, (iv) upper GI surgeries including endoscopic procedures, (v) relevant organic diseases on esophagogastroduodenoscopy (i.e., carcinomas, Schatzki ring, and para-esophageal hernia), (vi) opioid use in the last 1 month
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Yoshimasa
Middle name
Last name Hoshikawa
Organization Nippon Medical School Hospital
Division name Department of gastroenterology
Zip code 113-8603
Address 1-1-5 Sendagi Bunkyo-ku Tokyo
TEL 03-3822-2131
Email y-hoshikawa@nms.ac.jp

Public contact
Name of contact person
1st name Yoshimasa
Middle name
Last name Hoshikawa
Organization Nippon Medical School Hospital
Division name Department of gastroenterology
Zip code 113-8603
Address 1-1-5 Sendagi Bunkyo-ku Tokyo
TEL 03-3822-2131
Homepage URL
Email y-hoshikawa@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization self funding
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 Nippon Medical School Hospital
Address 1-1-5 Sendagi Bunkyo-ku Tokyo
Tel 03-3822-2131
Email nms_fuzokurinri@nms.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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 112
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 No longer recruiting
Date of protocol fixation
2021 Year 07 Month 29 Day
Date of IRB
2021 Year 07 Month 29 Day
Anticipated trial start date
2021 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information healthy volunteers participated in the study1 to investigate normal cutoff values of HRM metrics.

in study2, we retrospectively analyze HRM tracings, and investigate diagnostic yields for a diagnosis of relevant disorders of EGJ outflow

Management information
Registered date
2022 Year 01 Month 07 Day
Last modified on
2022 Year 01 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053134

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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