UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046572 |
|---|---|
| Receipt number | 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 | 2023/01/08 09:11:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
y-hoshikawa@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053134
