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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004012
Receipt No. R000004819
Scientific Title A study on usufullness of lower limit of palisade vessel as diagnostic marker for Barrett's esophagus with cancer risk
Date of disclosure of the study information 2010/08/06
Last modified on 2012/01/06

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Basic information
Public title A study on usufullness of lower limit of palisade vessel as diagnostic marker for Barrett's esophagus with cancer risk
Acronym A study on usufullness of lower limit of palisade vessel as diagnostic marker for Barrett's esophagus with cancer risk
Scientific Title A study on usufullness of lower limit of palisade vessel as diagnostic marker for Barrett's esophagus with cancer risk
Scientific Title:Acronym A study on usufullness of lower limit of palisade vessel as diagnostic marker for Barrett's esophagus with cancer risk
Region
Japan

Condition
Condition Barrett's esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the relation in the location of palisade vessel, squamo-columnar junction, and the LES as the physiological esophagogastric junction
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relation in the location of the hemoclip which is placed at the lower end of palisade vessel and the lower end of the LES
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1 Healthy volunteers
2 Subjects with written informed consent
Key exclusion criteria 1 Patients who cannot agree this study
2 Patients with bleeding tendency
3 Patients with esophageal varices,gastric varices, and esophageal stenosis
4 Severe disease in heart,liver and kidney.Severe hemotological disease
5 Drug allergy for lidocaine
6 expectant pregnancy,mother,mother with breast-feeding
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane University Faculty of Medicine School of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 89-1,Enya,Izumo,Shimane 693-8501,Japan
TEL 0853-20-2190
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Furuta
Organization Shimane University Faculty of Medicine School of Medicine
Division name Department of Gastroenterology
Zip code
Address 89-1,Enya,Izumo,Shimane 693-8501,Japan
TEL 0853-20-2190
Homepage URL
Email

Sponsor
Institute Shimane university faculty of medicine
Institute
Department

Funding Source
Organization Donation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 島根大学医学部付属病院(島根県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 06 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 Terminated
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information prospective study

Management information
Registered date
2010 Year 08 Month 06 Day
Last modified on
2012 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004819

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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