UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034596
Receipt No. R000039063
Scientific Title A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses
Date of disclosure of the study information 2018/10/22
Last modified on 2018/11/15

* 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 controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses
Acronym A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses
Scientific Title A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses
Scientific Title:Acronym A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses
Region
Japan

Condition
Condition solid pancreatic masses
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the non-inferiority of the endoscopic ultrasound-guided tissue acquisition of 25-G Franseen needle comparing with 22-G Franseen needle in solid pancreatic masses.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The tissue collection rate in each needle (cellularity score: 3,4,5)
Key secondary outcomes 1)Histological core collection rate in each needle(cellularity score: 5)
2)The tissue collection rate based on the tumor size, location, puncture rout and each pancreatic disease
3)Onsite diagnostic adequacy in each needle
4)Diagnostic accuracy in each needle
5)Specimen bloodiness in each needle
6)Ease of puncture in each needle
7)Needle visibility in each needle
8)Technical success rate in each needle
9)Adverse events

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 In EUS-FNA, 1st puncture using 25-G Franseen needle and 2nd puncture using 22-G Franseen needle.
Interventions/Control_2 In EUS-FNA, 1st puncture using 22-G Franseen needle and 2nd puncture using 25-G Franseen needle.
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 solid pancreatic masses who are referred to EUS-FNA
Key exclusion criteria 1)Patients with Performance status 4
2)Patients who have risk of bleeding, or with platelet count less than fifty thousand/mm2
3)Patients with anti-thrombotic agent 2 or more
4)Patients with pancreatic mass which we cannot detect by EUS
5)Pregnant woman
6)Patients less than 20 years old
7)Patients who do not agree to participate in this study
8)Patients who determined to be inappropriate
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironari Kato
Organization Okayama University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-4-1 Shikata-cho Kita-ku Okayama-city Okayama
TEL 086-235-7219
Email drkatocha@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Tomoda
Organization Okayama University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL 086-235-7219
Homepage URL
Email tomotake79@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization None
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 10 Month 22 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 20 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
2018 Year 10 Month 22 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039063

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.