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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004415
Receipt No. 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

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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
Email

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
Email shin-ya@nsknet.or.jp

Sponsor
Institute Third Department of Internal Medicine, University of Toyama
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004780

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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