UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021550 |
|---|---|
| Receipt number | R000024758 |
| Scientific Title | Peroral endoscopic myotomy for the treatment of achalasia: prospective multicenter study in Japan |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2019/03/17 15:13:30 |
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Basic information
Public title
Peroral endoscopic myotomy for the treatment of achalasia: prospective multicenter study in Japan
Acronym
POEM for achalasia : prospective multicenter study in Japan
Scientific Title
Peroral endoscopic myotomy for the treatment of achalasia: prospective multicenter study in Japan
Scientific Title:Acronym
POEM for achalasia : prospective multicenter study in Japan
Region
| Japan |
Condition
Condition
Esophageal achalasia
Classification by specialty
| Medicine in general | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy and safety of POEM for the treatment of patients with achalasia prospectively in multiple center in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment success of POEM procedure at one year
Treatment successful defined Eckardt score<3 and 3.
Key secondary outcomes
･Adverse event related to POEM procedure
･Treatment success of POEM procedure at
three months and two years
･Postoperative GERD
･Pressure of lower esophageal sphincter
･Time of procedure time
･Continuous use of proton pump inhibitor
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Peroral Endoscopic myotomy (POEM)
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
The patient who are diagnosed achalasia or related motility disorders, and considered the indication of POEM.
Key exclusion criteria
(1) The patients unable to undergo general anesthesia
(2) The patients whom attending doctor consider inappropriate
Target sample size
160
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 Disease 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 Hospital
Division name
Department of Gastroenterological Surgery
Zip code
814-0180
Address
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Homepage URL
poem.fukuoka@gmail.com
Sponsor or person
Institute
Showa University Koto-Toyosu 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
Fukuoka University Hospital
Address
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
Tel
092-801-1011
poem.fukuoka@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
昭和大学江東豊洲病院（東京都）
福岡大学病院（福岡県）
新潟大学医歯学総合病院（新潟県）
長崎大学病院（長崎県）
東北大学病院（宮城県）
神戸大学医学部附属病院（兵庫県）
ハートライフ病院（沖縄県）
大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
233
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 | 01 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024758
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
