UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016126 |
|---|---|
| Receipt number | R000018728 |
| Scientific Title | Questionnaire study of a single institution on the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2020/11/06 19:16:03 |
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Basic information
Public title
Questionnaire study of a single institution on the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Acronym
Study of the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Scientific Title
Questionnaire study of a single institution on the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Scientific Title:Acronym
Study of the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Region
| Japan |
Condition
Condition
esophageal achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
study the usefulness of POEM for esophageal achalasia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Eckardt score before and after treatment.
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
intervention of 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Patients with esophageal achalasia which has a current symptoms.
b. Patients had esophagus fluoroscopy and upper gastrointestinal endoscopy for diagnosis as esophageal acalasia.
c. Esophageal pressure measurement is not necessarily performed.
d. Treatment history (medicine, endoscopic balloon dilation, surgical history) does not matter.
e. Achalasia form classification, the degree of dilation is not limited.
f. Patientsdetermined to be reasonable for POEM in Gastroenterology Surgery Conference.
Key exclusion criteria
a. Patients have risk factors for POEM clinically.
b. minors.
c. Patients have no imformed consent of POEM.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okada |
Organization
Okayama University Hospital
Division name
Department of Endoscopy
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuusaku Sugihara |
Organization
Okayama University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7219
Homepage URL
y.sugi117@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
| 2017 | Year | 01 | Month | 06 | 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
| 2016 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 06 | 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 | 01 | Month | 05 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018728
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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