UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025738
Receipt number R000029614
Scientific Title Safety and efficacy of endoscopic ultrasound guided fine needle aspiration with core biopsy needle for pancreatic mass: A prospective study
Date of disclosure of the study information 2017/01/19
Last modified on 2018/08/02 10:22:08

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Basic information

Public title

Safety and efficacy of endoscopic ultrasound guided fine needle aspiration with core biopsy needle for pancreatic mass:
A prospective study

Acronym

ProCore Study for Pancreatic Mass

Scientific Title

Safety and efficacy of endoscopic ultrasound guided fine needle aspiration with core biopsy needle for pancreatic mass:
A prospective study

Scientific Title:Acronym

ProCore Study for Pancreatic Mass

Region

Japan


Condition

Condition

Pancreatic Mass

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the novel FNB needle with forward bevel

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

accurate histological diagnosis

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

patients with a solid pancreatic mass larger than 15 mm which required EUS-FNA for pathological confirmation

Key exclusion criteria

(1) difficulty in endoscopic approach due to prior gastroduodenal surgery, (2) daily use of anti-coagulant medicine, (3) platelet count of less than 50,000mm3, (4) PT-INR of more than 1.5.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Sasahira

Organization

The Cancer Institute Hospital of JFCR

Division name

Department of Gastroenterology

Zip code


Address

3-8-31, Ariake, Koto-Ku, Tokyo

TEL

03-3520-0111

Email

naoki.sasahira@jfcr.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryo Kanata

Organization

The Cancer Institute Hospital of JFCR

Division name

Department of Gastroenterology

Zip code


Address

3-8-31, Ariake, Koto-Ku, Tokyo

TEL

03-3520-0111

Homepage URL


Email

ryo.kanata@jfcr.or.jp


Sponsor or person

Institute

Japanese Foundation for Cancer Research

Institute

Department

Personal name



Funding Source

Organization

Self

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

2017 Year 01 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


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 01 Month 15 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 25 Day

Last follow-up date

2018 Year 04 Month 25 Day

Date of closure to data entry

2018 Year 04 Month 25 Day

Date trial data considered complete

2018 Year 05 Month 25 Day

Date analysis concluded

2018 Year 06 Month 30 Day


Other

Other related information

NON


Management information

Registered date

2017 Year 01 Month 19 Day

Last modified on

2018 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029614


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name