UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030634
Receipt number R000034974
Scientific Title Histologic diagnosis of pancreatic masses using 22-gauge endoscopic ultrasound needles with and without franseen design :A multicenter randomized controlled trial
Date of disclosure of the study information 2018/04/01
Last modified on 2021/05/05 19:31:07

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Basic information

Public title

Histologic diagnosis of pancreatic masses using 22-gauge endoscopic ultrasound needles with and without franseen design :A multicenter randomized controlled trial

Acronym

A multicenter randomized controlled trial for Endoscopic ultrasound-guided fine needle aspiration

Scientific Title

Histologic diagnosis of pancreatic masses using 22-gauge endoscopic ultrasound needles with and without franseen design :A multicenter randomized controlled trial

Scientific Title:Acronym

A multicenter randomized controlled trial for Endoscopic ultrasound-guided fine needle aspiration

Region

Japan


Condition

Condition

pancreatic mass

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare histological diagnosis ability of 22-gauge standard needle and 22-gauge franseen needle in patients with pancreatic mass.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Accuracy for histrogical diagnosis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

EUS-FNA using 22-gauge standard needle

Interventions/Control_2

EUS-FNA using 22-gauge 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

100 years-old >

Gender

Male and Female

Key inclusion criteria

# patients with pancreatic mass detected by imaging
# Performace status 1 or 2
# Case that need a histologic diagnosis for the choice of the therapeutic method
# Written informed consent

Key exclusion criteria

# Inability to perform EUS-FNA
# Case with the bleeding tendency
# Inability to perform endoscopy
# Inabiltity to depict pancreatic mass by EUS
# Serious failure of other organs
# Case judged to be inadequate for this study

Target sample size

520


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Kitano

Organization

Wakayama medical university

Division name

Second Department of Internal Medicine

Zip code


Address

811-1 Kimiidera Wakayama

TEL

073-447-2300

Email

kitano@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Itonaga

Organization

Wakayama medical university

Division name

Second Department of Internal Medicine

Zip code


Address

811-1 Kimiidera Wakayama

TEL

073-447-2300

Homepage URL


Email

itonaga@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama medical university

Institute

Department

Personal name



Funding Source

Organization

Boston Scientific Corporation

Organization

Division

Category of Funding Organization

Profit organization

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 04 Month 01 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

Completed

Date of protocol fixation

2017 Year 12 Month 28 Day

Date of IRB

2017 Year 11 Month 27 Day

Anticipated trial start date

2018 Year 03 Month 31 Day

Last follow-up date

2021 Year 03 Month 30 Day

Date of closure to data entry

2021 Year 03 Month 30 Day

Date trial data considered complete

2021 Year 03 Month 30 Day

Date analysis concluded

2021 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 29 Day

Last modified on

2021 Year 05 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034974


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name