UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021779
Receipt No. R000025118
Scientific Title A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node
Date of disclosure of the study information 2016/04/05
Last modified on 2016/04/04

* 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 A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node
Acronym A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node
Scientific Title A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node
Scientific Title:Acronym A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node
Region
Japan

Condition
Condition solid pancreatic mass lesions and swelling lymph nodes
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is evaluating the efficacy of EUS sonopsy CY by comparing EUS sonopsy CY with 22G EUS-FNAB(EchoTip ProCore)needle.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The tissue collection rate and accuracy rate in each group.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 In EUS-FNA, 1st and 3rd puncture using EUS sonopsy CY, 2nd and 4th puncture using 22GEUSFNAB needle(EchoTip Procore).
Interventions/Control_2 In EUS-FNA, 1st and 3rd puncture using 22GEUSFNAB needle(EchoTip Procore), 2nd and 4th puncture using EUS sonopsy CY.
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 Patients with pancreatic mass or swelling lymph node who are refered to EUS-FNA
Key exclusion criteria 1.Performance Status (PS)4.
2.The patient who has serious disease.
3.The pacient with anticoagulant therapy.
4.The woman becomes pregnant or might be pregnant.
5.Insertion of the endoscope is impossible.
6.The patient was judged the physician to be inappropriate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi IRISAWA
Organization Fukushima Medical University Aizu Medical Center
Division name gastroenterology
Zip code
Address 21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City
TEL (0242)75-2100
Email irisawa@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo IGARASHI
Organization Fukushima Medical University Aizu Medical Center
Division name gastroenterology
Zip code
Address 21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City
TEL (0242)75-2100
Homepage URL
Email ryo-i@fmu.ac.jp

Sponsor
Institute Fukushima Medical University Aizu Medical Center
Institute
Department

Funding Source
Organization Fukushima Medical University Aizu Medical Center
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 04 Month 05 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 Open public recruiting
Date of protocol fixation
2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 05 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025118

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.