UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033530
Receipt number R000038232
Scientific Title Multicenter prospective registration study evaluating diagnostic yield of the 22G Franseen needle in patients undergoing EUS-guided tissue acquisition of pancreatic solid lesions
Date of disclosure of the study information 2018/07/30
Last modified on 2018/07/27 06:15:17

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Basic information

Public title

Multicenter prospective registration study evaluating diagnostic yield of the 22G Franseen needle in patients undergoing EUS-guided tissue acquisition of pancreatic solid lesions

Acronym

Multicenter prospective registration study evaluating EUS-FNA using the 22G Franseen needle

Scientific Title

Multicenter prospective registration study evaluating diagnostic yield of the 22G Franseen needle in patients undergoing EUS-guided tissue acquisition of pancreatic solid lesions

Scientific Title:Acronym

Multicenter prospective registration study evaluating EUS-FNA using the 22G Franseen needle

Region

Japan


Condition

Condition

Pancreatic tumors

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the diagnostic yield of EUS-FNB using the 22G Franseen needle in patients with pancreatic solid lesions

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic accuracy of EUS-FNB using the 22G Franseen needle

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

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Patients who are over 20 years old.
2)Patients with pancreatic solid tumors.
3)Patients who need histopathological diagnosis for pancreatic neoplasms by EUS-FNB.
4)Patients who provided written informed consent.

Key exclusion criteria

1)Patients who are not applicable to endoscopy and EUS-FNB.
2)Patients who judged as inappropriate by attendant doctor.
3)Patients who rejected participating in this study.

Target sample size

235


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yousuke Nakai

Organization

Tokyo University

Division name

Department of Gastroenterology

Zip code


Address

7-3-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8655

TEL

03-3815-5411

Email

ynakai-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunaga Ishigaki

Organization

Tokyo University

Division name

Department of Gastroenterology

Zip code


Address

7-3-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8655

TEL

03-3815-5411

Homepage URL


Email

ishigakikazunaga@gmail.com


Sponsor or person

Institute

Tokyo University

Institute

Department

Personal name



Funding Source

Organization

Tokyo 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 07 Month 30 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 07 Month 17 Day

Date of IRB


Anticipated trial start date

2018 Year 07 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Data of EUS-FNB using the 22G Franseen needle


Management information

Registered date

2018 Year 07 Month 27 Day

Last modified on

2018 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038232


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name