UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037513 |
|---|---|
| Receipt number | R000042768 |
| Scientific Title | Multicenter collaborative retrospective study of POEM for achalasia |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2019/07/28 16:04:39 |
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Basic information
Public title
Multicenter collaborative retrospective study of POEM for achalasia
Acronym
Multicenter collaborative retrospective study of POEM for achalasia
Scientific Title
Multicenter collaborative retrospective study of POEM for achalasia
Scientific Title:Acronym
Multicenter collaborative retrospective study of POEM for achalasia
Region
| Japan |
Condition
Condition
Achalasia and esophageal motility disorders
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Operative medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)To verify short-term and long term outcome of POEM
2)To identify the risk factor of GERD after POEM
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of GERD after POEM
The severity of GERD after POEM
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing POEM for esophageal achalasia at 12 facilities in Japan between September 2008 and March 2018
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Haruhiro |
| Middle name | |
| Last name | Inoue |
Organization
Showa University Koto-Toyosu Hospital
Division name
Digestive Diseases Center
Zip code
135-8577
Address
Toyosu5-1-38, Koto-Ku, Tokyo, 135-8577, Japan
TEL
03-6204-6064
haruinoue777@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hironari |
| Middle name | |
| Last name | Shiwaku |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
8140180
Address
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Homepage URL
hiro.shiwaku@gmail.com
Sponsor or person
Institute
Digestive Diseases Center, Showa University Koto-Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Gastroenterological Surgery Fukuoka University Faculty of Medicine
Address
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
Tel
09095675463
hiro.shiwaku@gmail.com
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
| 2019 | Year | 08 | 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
2000
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
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 07 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042768
