UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030773
Receipt No. R000035005
Scientific Title Evaluation of Optimal White Core Specimen Length Obtained by EUS-FNAB with 22-gauge Franseen Needle -A Single-Center Prospective Pilot Traial-
Date of disclosure of the study information 2018/01/11
Last modified on 2019/07/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of Optimal White Core Specimen Length Obtained by EUS-FNAB with 22-gauge Franseen Needle
-A Single-Center Prospective Pilot Traial-
Acronym Evaluation of Optimal Specimen Obtained by EUS-FNAB
Scientific Title Evaluation of Optimal White Core Specimen Length Obtained by EUS-FNAB with 22-gauge Franseen Needle
-A Single-Center Prospective Pilot Traial-
Scientific Title:Acronym Evaluation of Optimal Specimen Obtained by EUS-FNAB
Region
Japan

Condition
Condition Subepitheliai lesions in the upper gastrointestinal tract
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate optimal white core specimen length (cut-off value) required for pathological diagnosis using a stereoscopic microscope in EUS-FNAB
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes optimal white biopsy specimen length (cut-off value)
Key secondary outcomes diagnostic accuracy
tissue acquisition rate
adverse event rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 22-gauge franseen needle
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 1) subepitelial lesions in upper gastrointestinal tract which are required EUS-FNAB
2) providing written informed consent, and
age =or >20
Key exclusion criteria 1) high risk of puncturing cystic part
2) bleeding disorders
3) patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mitsuhiro
Middle name
Last name Kida
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL +81-42-778-8111
Email m-kida@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL +81-42-778-8111
Homepage URL
Email kokuwaki@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology Kitasato University School of Medicine
Institute
Department

Funding Source
Organization N/A
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 Kitasato University Institutional Review Board
Address 1-15-1, Kitasato Minami Sagamihara Kanagawa, Japan
Tel 81-42-778-8111
Email rinri@med.kitasato-u.ac.jp

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 北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 11 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 30
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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 03 Day
Date of IRB
2018 Year 03 Month 05 Day
Anticipated trial start date
2018 Year 03 Month 05 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 11 Day
Last modified on
2019 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035005

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.