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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035323
Receipt No. R000039981
Scientific Title Examination of body composition change of patients with esophagus Achalasia - comparison before and after Peroral endoscopic myotomy -
Date of disclosure of the study information 2018/12/20
Last modified on 2018/12/20

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Basic information
Public title Examination of body composition change of patients with esophagus Achalasia - comparison before and after Peroral endoscopic myotomy -
Acronym Esophagus Achalasia and body composition change
Scientific Title Examination of body composition change of patients with esophagus Achalasia - comparison before and after Peroral endoscopic myotomy -
Scientific Title:Acronym Esophagus Achalasia and body composition change
Region
Japan

Condition
Condition Esophagus Achalasia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is examination of body composition change of patients with esophagus Achalasia - comparison before and after Peroral endoscopic myotomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is body composition change of patients with esophagus Achalasia - comparison before and after Peroral endoscopic myotomy.
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
15 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Symptomatic patients with esophagus Achalasia
Key exclusion criteria 1) Patients having another severe disorders
2) Patients who can not open the mouth widely
3) Patients who are judged by the investigators to be inappropriate participants in the study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Terai
Organization Graduate School of Medical and Dental Sciences, Niigata University
Division name Division of Gastroenterology and Hepatology
Zip code
Address 757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL 025-227-2207
Email terais@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Mizusawa
Organization Graduate School of Medical and Dental Sciences, Niigata University
Division name Division of Gastroenterology and Hepatology
Zip code
Address 757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL 025-227-2207
Homepage URL
Email tmizu@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization N/A
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
Email

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
2018 Year 12 Month 20 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational research

Management information
Registered date
2018 Year 12 Month 20 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039981

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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