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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036641
Receipt No. R000041742
Scientific Title Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Date of disclosure of the study information 2019/05/03
Last modified on 2019/05/03

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Basic information
Public title Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Acronym Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Scientific Title Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Scientific Title:Acronym Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Region
Japan

Condition
Condition solid lesion
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine histopathological diagnosis capability of EUS-FNA using a 22-gauge Acquire needle
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The diagnostic accuracy of histology
Key secondary outcomes The number of passes for diagnosis
Adverse event

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
Interventions/Control_1 EUS-FNA is performed on solid tumors three times using a 22G acquire 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 Participants were patients with solid masses (>15mm) who were scheduled to undergo EUS-FNA.
Key exclusion criteria Patients were excluded if they met any of the following criteria: (1) age < 20 years, (2) coagulopathy (international normalized ratio > 1.5 or platelet count < 50,000/mm ), (3) pregnant women, (4) GI obstruction, (5) a European Cooperative Oncology Group performance status of 4.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Takuji
Middle name
Last name Iwashita
Organization Gifu University Hospital
Division name First Dept. of Internal Medicine
Zip code 501-1194
Address 1-1 Yanagido, Gifu 501-1194
TEL 058-230-6308
Email takuji@w7.dion.ne.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Uemura
Organization Gifu University Hospital
Division name First Dept. of Internal Medicine
Zip code 501-1194
Address 1-1 Yanagido, Gifu 501-1194
TEL 058-230-6308
Homepage URL
Email ueshin550621@gmail.com

Sponsor
Institute Gifu University Hospital, First Dept. of Internal Medicine
Institute
Department

Funding Source
Organization Gifu University Hospital, First Dept. of Internal Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Gifu Municipal Hospital
Tyunou Kousei Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gifu University Hospital Independent Ethics Committee
Address 1-1 Yanagido, Gifu
Tel 058-230-6059
Email gjme00004@jim.gifu-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 岐阜大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 03 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 75
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
2017 Year 09 Month 06 Day
Date of IRB
2017 Year 09 Month 06 Day
Anticipated trial start date
2017 Year 09 Month 07 Day
Last follow-up date
2019 Year 09 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 03 Day
Last modified on
2019 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041742

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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