UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016445 |
|---|---|
| Receipt number | R000019094 |
| Scientific Title | Study of the efficacy and safety of POEM(Per-oral endoscopic myotomy) |
| Date of disclosure of the study information | 2015/02/24 |
| Last modified on | 2026/02/13 00:52:03 |
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Basic information
Public title
Study of the efficacy and safety of POEM(Per-oral endoscopic myotomy)
Acronym
The efficacy and safety of POEM
Scientific Title
Study of the efficacy and safety of POEM(Per-oral endoscopic myotomy)
Scientific Title:Acronym
The efficacy and safety of POEM
Region
| Japan |
Condition
Condition
Esophageal achalasia
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Per-oral endoscopic myotomy for esophageal achalasia (Per-oral endscopic myotomy: POEM) was certified advanced medical technology by the Ministry of Health, Labour and Welfare in July 2012 in Japan. This time, this treatment method is introduced into the Tohoku University Hospital, to examine the efficacy and safety of POEM for esophageal achalasia. After the end of this study, to perform the application of highly advanced medical treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)percentage-of-completion
2)all adverse event incidence
Key secondary outcomes
1) treatment time
2) postoperative hospital stay
3) subjective symptoms of the patient in the treatment before and after
4) health care costs during surgery hospitalization
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
POEM is performed
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) esophageal mortility function disorders patients and esophageal stenosis symptoms of esophageal achalasia
2) PS (ECOG Performance Status Scale): 0-2
3) Gender: both
4) major organs (bone marrow, heart, liver, kidney, lung function, etc.) is helathy, which can be general anesthesia
5)the consent in writing from the person
Key exclusion criteria
1) emergency surgery cases
2) medical doctor judged inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kamei |
| Middle name | |
| Last name | Takashi |
Organization
Tohoku university graduate school of medicine
Division name
Department of advanced surgery
Zip code
9808574
Address
1-1,seiryo-cyo,aoba-ku,sendai city,miyagi prefecture
TEL
022-717-7214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Sato |
Organization
Tohoku university
Division name
Department of Surgery, Division of Organ Transplantation, Reconstruction & Endoscopic Surgery
Zip code
9808574
Address
1-1,seiryou-cyo,aoba-ku,sendai city,miyagi prefecture
TEL
022-717-7214
Homepage URL
schiaki@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku university hospital
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
Clinical Ethics Committee, Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi, Japan
Tel
022-717-7000
rinri-2@proj.med.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019094
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10388-021-00875-5
Number of participants that the trial has enrolled
10
Results
The therapeutic effect of the initial 10 cases was extremely high, with significant improvements in both Eckardt score and LES pressure.The efficacy of POEM is influenced by the distance and direction of the incision. To properly perform POEM, a certain number of POEM cases and thorough knowledge of esophageal motility disorders, including achalasia, are necessary. When introducing POEM, it should be performed under the guidance of an operator with experience at a high-volume center.
Results date posted
| 2026 | Year | 02 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
an untreated patient with esophageal achalasia
Participant flow
Patients who were referred to our department for diagnosis and treatment provided informed consent to participate in the clinical trial, which was subsequently carried out.
Adverse events
nothing
Outcome measures
Eckardt score,complication
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019094
