UMIN-CTR Clinical Trial

Basic information
Public title	Esophageal motility disorders caused by esophageal eosinophilia
Acronym	Esophageal motility disorders by eosinophil infiltration
Scientific Title	Esophageal motility disorders caused by esophageal eosinophilia
Scientific Title:Acronym	Esophageal motility disorders by eosinophil infiltration
Region	Japan

Condition
Condition	Esophageal motility disorders Eosinophilic esophagitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the esophageal motility in the patients with eosinophilic esophagitis , the impact of eosinophil infiltration on primary esophageal motility disorders, thus we will find the useful knowledge for the strategy to choose the best treatment for the patients with esophageal motility disorders
Basic objectives2	Others
Basic objectives -Others	Pathophysiological investigation
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The prevalence of esophageal motility disorders in the patients with eosinophilic infiltration into esophageal mucosa
Key secondary outcomes	The prevalence of eosinophil infiltration among eosinophilic esophagitis

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent both esophageal manometry and endoscopic biopsy to determine eosinophil infiltration in esophageal mucosa
Key exclusion criteria	None
Target sample size	306

Research contact person
Name of lead principal investigator	1st name Toshio Middle name Last name Uraoka
Organization	Gunma University Hospital
Division name	Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	0272208137
Email	uraoka@gunma-u.ac.jp

Public contact
Name of contact person	1st name Hiroko Middle name Last name Hosaka
Organization	Gunma University Hospital
Division name	Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	027-220-8137
Homepage URL
Email	hhosaka@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital
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	Gunma University Hospital
Address	3-39-22Showa-machi
Tel	0272208137
Email	hitotaisho-ciru@ml.gunma-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	群馬大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	18
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	2016 Year 11 Month 01 Day
Date of IRB	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Unpublished

Management information
Registered date	2018 Year 04 Month 25 Day
Last modified on	2022 Year 10 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034828