UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021235 |
|---|---|
| Receipt number | R000024497 |
| Scientific Title | The impact of peroral endoscopic myotomy(POEM) for secondary sarcopenia in esophageal achalasia patients |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2022/06/03 11:45:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The impact of peroral endoscopic myotomy(POEM) for secondary sarcopenia in esophageal achalasia patients
Acronym
The impact of POEM for sarcopenia in achalasia patients
Scientific Title
The impact of peroral endoscopic myotomy(POEM) for secondary sarcopenia in esophageal achalasia patients
Scientific Title:Acronym
The impact of POEM for sarcopenia in achalasia patients
Region
| Japan |
Condition
Condition
esophageal achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of peroral endoscopic myotomy on secondary sarcopenia in esophageal achalasia patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of skeltal muscle mass after POEM for achalasia patients
Key secondary outcomes
Prevalence of sarcopenia in achalasia patients
Risk factors for sarcopenia in achalasia patients
Postoperative complications in achalasia patients undergoing POEM
Changes of nutritional status after POEM
Quality of life assessment after POEM
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who were diagnosed with achalasia or other esophageal motility disorders, such as jackhammer esophagus or distal esophageal spasm
Key exclusion criteria
Patients who were <18 years old, had dementia, or were bedridden
Target sample size
61
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Abe |
Organization
Kobe University Hospital
Division name
Gastroenterology
Zip code
650-0017
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL
078-382-5111
abe627@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Abe |
Organization
Kobe University Hospital
Division name
Gastroenterology
Zip code
650-0017
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL
078-382-5111
Homepage URL
abe627@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University 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
Kobe university clinical and translational research center
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
Tel
078-382-5652
rinri@med.kobe-u.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
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://academic.oup.com/dote/article/32/8/doz022/5450337?login=true
Publication of results
Unpublished
Result
URL related to results and publications
https://academic.oup.com/dote/article/32/8/doz022/5450337?login=true
Number of participants that the trial has enrolled
61
Results
The median percentage increase in ASM among the 61 patients was 2.4%. ASM (16.0 kg vs 16.8 kg, P = 0.0002) and ASMI (6.5 kg/m2 vs 6.7 kg/m2, P = 0.0001) were significantly increased at 3 months after the POEM
Results date posted
| 2022 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (median) 50 years
Sex (male) 44.2%
Achalasia　87.1%, Spastic esophageal disorder12.9%
Participant flow
During the study period, 67 patients underwent POEM. One patient who was less than 18 years old and three patients with dementia were excluded; thus, 63 patients were enrolled in this study. Two patients dropped out of the surveillance program, making 61 eligible for this study.
Adverse events
Perioperative complications 6.6%
Outcome measures
The median percentage increase in ASM among the 61 patients was 2.4%. ASM (16.0 kg vs 16.8 kg, P = 0.0002) and ASMI (6.5 kg/m2 vs 6.7 kg/m2, P = 0.0001) were significantly increased at 3 months after the POEM.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
The patient with achalasia who plan to receive POEM in our hospital from October 1,2016
Management information
Registered date
| 2016 | Year | 02 | Month | 27 | Day |
Last modified on
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024497
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
