UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004415 |
|---|---|
| Receipt number | R000004780 |
| Scientific Title | Optimal duration of proton pump inhibitor treatment for endoscopic submucosal dissection-induced ulcers |
| Date of disclosure of the study information | 2010/10/20 |
| Last modified on | 2010/11/14 12:19:57 |
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Basic information
Public title
Optimal duration of proton pump inhibitor treatment for endoscopic submucosal dissection-induced ulcers
Acronym
ESDPPI
Scientific Title
Optimal duration of proton pump inhibitor treatment for endoscopic submucosal dissection-induced ulcers
Scientific Title:Acronym
ESDPPI
Region
| Japan |
Condition
Condition
gastric mucosal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the optimal duration of proton pump inhibitor treatment for ESD-induced ulcers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
At 8 weeks after ESD, % S stages Patients.
Key secondary outcomes
The size of the ulcer after ESD
Ulcer stage after ESD
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ESD for gastric mucosal neoplasm
Key exclusion criteria
serious complications including cardiac, haematological, renal and/or hepatic disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Sugiyama |
Organization
University of Toyama
Division name
Department of Gastroenterology
Zip code
Address
2630, Sugitani, Toyama-city, Toyama-ken, Japan
TEL
081-76-434-7301
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kajiura |
Organization
University of Toyama
Division name
Department of Gastroenterology
Zip code
Address
2630, Sugitani, Toyama-city, Toyama-ken, Japan
TEL
081-76-434-7301
Homepage URL
shin-ya@nsknet.or.jp
Sponsor or person
Institute
Third Department of Internal Medicine, University of Toyama
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
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
富山大学附属病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | 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
Completed
Date of protocol fixation
| 2005 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | 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
To evaluate the optimal duration of proton pump inhibitor treatment for ESD-induced ulcers.
Management information
Registered date
| 2010 | Year | 10 | Month | 19 | Day |
Last modified on
| 2010 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004780
