UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020311 |
|---|---|
| Receipt number | R000023443 |
| Scientific Title | Change of the muscle layer thickening in esophageal achalasia |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2018/12/24 16:02:01 |
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Basic information
Public title
Change of the muscle layer thickening in esophageal achalasia
Acronym
Change of the muscle layer in achalasia
Scientific Title
Change of the muscle layer thickening in esophageal achalasia
Scientific Title:Acronym
Change of the muscle layer in achalasia
Region
| Japan |
Condition
Condition
esophageal achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the factors associated with the muscle layer thickening in esophageal achalasia
Basic objectives2
Others
Basic objectives -Others
Associated factor
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The factors associated with the muscle layer thickening in esophageal achalasia
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Achalasia patient
The patient with more than Edcardt score 3
Key exclusion criteria
The general condition not able to tolerate general anesthesia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinwa Tanaka MD, PhD |
Organization
Kobe University Hospital
Division name
Gastroenterology
Zip code
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6305
tanakas@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinwa Tanaka MD, PhD |
Organization
Kobe University Hospital
Division name
Gastroenterology
Zip code
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6305
Homepage URL
tanakas@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
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
Address
Tel
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
| 2016 | Year | 01 | Month | 01 | 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
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
| 2015 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patient with achalasia who plan to receive POEM in our hospital from April 2015
Management information
Registered date
| 2015 | Year | 12 | Month | 22 | Day |
Last modified on
| 2018 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023443
