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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017537
Receipt No. R000020323
Scientific Title Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Date of disclosure of the study information 2015/06/01
Last modified on 2015/05/13

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Basic information
Public title Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Acronym Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Scientific Title Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Scientific Title:Acronym Observational study of endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing process
Region
Japan

Condition
Condition Gastric neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Endoscopic gastric submucosal dissection examined the factors that affect the healing after (ESD) artificial ulcer
Basic objectives2 Others
Basic objectives -Others This study is to observe the healing process of the artificial ulcer after ESD to target the ESD enforcement patient to stomach tumor esophagus, stomach, duodenum by endoscopy (EGD).
The size of the artificial ulcer after ESD enforcement (ulcer size (length and breadth: mm)) are measured, then the appropriate EGD enforcement when it is determined that it is necessary to the attending physician within the normal practice range, of ulcer bottom the size of the measurement and I do healing judgment of therapy after ulcer.
The patient's background in healing artificial ulcer to consider whether there is an influence of (age, gender, medical history, height, weight, BMI, site of the artificial ulcer, size, such as the type of antacid used).
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Reduction ratio of ESD after artificial ulcer, state of healing
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

Not applicable
Gender Male and Female
Key inclusion criteria Patient stomach ESD enforcement
Key exclusion criteria Patients who became a surgery after ESD
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Sasaki
Organization Aichi Medical University
Division name Gastroenterology
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan
TEL 0561-62-3311
Email shimozato.akihiro.274@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Shimozato
Organization Aichi Medical University
Division name Gastroenterology
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan
TEL 0561-62-3311
Homepage URL
Email shimozato.akihiro.274@mail.aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Aichi Medical University
Organization
Division
Category of Funding Organization Other
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 愛知医科大学(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 06 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
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 Preinitiation
Date of protocol fixation
2015 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information age, sex, medical history, height, weight, BMI, the site of an artificial ulcer size, the type of antacids

Management information
Registered date
2015 Year 05 Month 13 Day
Last modified on
2015 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020323

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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