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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000030981
Receipt No. R000035349
Scientific Title Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Date of disclosure of the study information 2018/01/24
Last modified on 2019/03/04

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Basic information
Public title Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Acronym Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Scientific Title Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Scientific Title:Acronym Inter-rater agreement on the Endoscopic ultrasound feature of lymphadenopathy
Region
Japan

Condition
Condition lymphadenopathy
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Findings with a high degree of interrater agreement from the ultrasonographic findings adopted in the EUS diagnostic criteria for lymphadenopathy with the objective of proposing new diagnostic criteria for lymphadenopathy using EUS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes interrater agreement from the ultrasonographic findings for lymphadenopathy
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
22 years-old <=
Age-upper limit
91 years-old >=
Gender Male and Female
Key inclusion criteria EUS-FNA for lymphadenopathy of unknown origin observed in the mediastinal and abdominal cavities at Aizu Medical Center of Fukushima Medical University between June 2013 and August 2017.
Key exclusion criteria biopsy and cytology were insufficient case
Target sample size 71

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Irisawa
Organization Aizu Medical center, Fukushima Medical University
Division name Department of Gastroenterology
Zip code
Address 21-2 Maeda yazawa kawahigashicho aizuwakamatsu-si Fukushima, Japan
TEL 0242-75-2100
Email irisawa@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Takasaki
Organization Aizu Medical center, Fukushima Medical University
Division name Department of Gastroenterology
Zip code
Address 21-2 Maeda yazawa kawahigashicho aizuwakamatsu-si Fukushima, Japan
TEL 0242-75-2100
Homepage URL
Email magidora9@gmail.com

Sponsor
Institute Aizu Medical center, Fukushima Medical University
Institute
Department

Funding Source
Organization Aizu Medical center, Fukushima 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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2017 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 21 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2018 Year 07 Month 31 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2019 Year 03 Month 01 Day

Other
Other related information Our subjects were 60 patients (with 68 lesions) who were subjected to detailed EUS observation and EUS-FNA for lymphadenopathy of unknown origin observed in the mediastinal and abdominal cavities at Aizu Medical Center of Fukushima Medical University between June 2013 and August 2017.

Management information
Registered date
2018 Year 01 Month 24 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035349

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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