UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035274 |
|---|---|
| Receipt number | R000040188 |
| Scientific Title | Prospective observational study on the usefulness of muscle layer ressection biopsy for muscle layer biopsy for patients with esophageal achalasia who underwent per-oral endoscopic myotomy |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2018/12/17 02:51:00 |
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Basic information
Public title
Prospective observational study on the usefulness of muscle layer ressection biopsy for muscle layer biopsy for patients with esophageal achalasia who underwent per-oral endoscopic myotomy
Acronym
Clinical study on the usefulness of muscule layer ressection biopsy for muscule layer biopsy for patients with esophagus achalasia
Scientific Title
Prospective observational study on the usefulness of muscle layer ressection biopsy for muscle layer biopsy for patients with esophageal achalasia who underwent per-oral endoscopic myotomy
Scientific Title:Acronym
Clinical study on the usefulness of muscule layer ressection biopsy for muscule layer biopsy for patients with esophagus achalasia
Region
| Japan |
Condition
Condition
esophageal achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of histopathological evaluation of muscle layer resection biopsy (MRB) compared to muscle layer biopsy (MB) for esophageal achalasia patients and achalasia related diseases who underwent peroral endoscopic myotomy (POEM).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Comparison of the number of Auerbach's myentric plexus per muscular specimen of LES part collected by using MB and MRB.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) The age at the time of consent acquisition is 20 years old or over.
(2) Patients who are diagnosed as esophageal achalasia and achalasia related diseases by using endoscopy, esophagram and high resolution manometry.
(3) symptomatic patients with Eckardt symptom score 3 or more.
(4) Patients who will undergo POEM.
(5) Document consents are obtained from the subjects prior to this research.
Key exclusion criteria
(1) Patients who can not obtain consent from himself / herself.
(2) Patients under 20 years old.
(3) Patients who take antithrombotic drugs
(4) Patients underwent POEM or surgical myotomy before this research.
(5) Patients who are considered inappropriate for this research by the research director.
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Abe |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL
078-382-5774
abe627@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Abe |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL
078-382-5774
Homepage URL
abe627@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
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
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
| 2019 | Year | 02 | 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
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Consecutive series of patients who will undergo POEM in our hospital from Febrary 1, 2019 are enrolled in this study. The collection of full-thickness muscle layer are performed by using both muscle layer biopsy and muscle layer ressection biopsy among same patients and the usefullness for histopathological examination are compared each other.
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040188
| 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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| Registered date | File name |
