UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042538 |
|---|---|
| Receipt number | R000048524 |
| Scientific Title | Long-term outcomes of ESD-G (endoscopic submucosal dissection for gastric esophageal reflux disease) for proton pump inhibitor-refractory gastroesophageal reflux disease |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2022/04/13 17:36:46 |
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Basic information
Public title
ESD-G (endoscopic submucosal dissection for gastric esophageal reflux disease) for proton pump inhibitor-refractory gastroesophageal reflux disease
Acronym
ESD-G
Scientific Title
Long-term outcomes of ESD-G (endoscopic submucosal dissection for gastric esophageal reflux disease) for proton pump inhibitor-refractory gastroesophageal reflux disease
Scientific Title:Acronym
Long term outcomes of ESD-G
Region
| Japan |
Condition
Condition
PPI-refractory GERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the long-term course of patients who have undergone ESD-G.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PPI status for patients more than 5 years after ESD-G
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have been undergoing ESD-G for more than 5 years
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Medical College
Division name
Second department of internal medicine
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki
TEL
072-683-1221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ota |
Organization
Osaka medical college
Division name
Second department of internal medicine
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki
TEL
072-683-1221
Homepage URL
clash_kaz@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Ethic review committee at osaka medical college
Address
2-7, Daigaku-machi, Takatsuki
Tel
072-683-1221
clash_kaz@yahop.co.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
| 2020 | Year | 12 | 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
42
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
| 2014 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PPI dosage and symptoms in the long-term course after ESD-G
Management information
Registered date
| 2020 | Year | 11 | Month | 24 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048524
| 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 |
