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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000021550 |
Receipt No. | 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 |
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 |
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Condition | ||||
Condition | Esophageal achalasia | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The patient who are diagnosed achalasia or related motility disorders, and considered the indication of POEM.
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Key exclusion criteria | (1) The patients unable to undergo general anesthesia
(2) The patients whom attending doctor consider inappropriate |
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Target sample size | 160 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Showa University Koto-Toyosu 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 | 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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024758 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |