UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012028
Receipt number R000014057
Scientific Title FNB is not associated with better histological result for the diagnosis of pancreatic solid lesion, but can increase the overall diagnostic accuracy
Date of disclosure of the study information 2014/12/31
Last modified on 2013/10/13 09:58:06

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Basic information

Public title

FNB is not associated with better histological result for the diagnosis of pancreatic solid lesion, but can increase the overall diagnostic accuracy

Acronym

Comparison of diagnostic accuracy of EUS-FNB and FNA for pancreatic solid lesion

Scientific Title

FNB is not associated with better histological result for the diagnosis of pancreatic solid lesion, but can increase the overall diagnostic accuracy

Scientific Title:Acronym

Comparison of diagnostic accuracy of EUS-FNB and FNA for pancreatic solid lesion

Region

Asia(except Japan)


Condition

Condition

complete

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The object of study is to compare of diagnostic accuracy of EUS-guided FNB and FNA for diagnosing of pancreatic solid mass.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

diagnostic accuracy

Key secondary outcomes

the rate of technical failure, complication and number of needle passes for diagnosis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

EUS-guided fine-needle biopsy (EUS-FNB) device with ProCore reverse bevel technology (Wilson-Cook Medical, Winston-Salem, NC)

Interventions/Control_2

EUS-guided fine-needle aspiration (EUS-FNA) device with conventional needle (Echotip;Wilson-Cook Medical)

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

18 years-old <

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

All patients were confirmed to have solid pancreatic masses by at least a single investigational modality, mainly computed tomography (CT), magnetic resonance imaging (MRI) or EUS.

Key exclusion criteria

1) bleeding tendencies (international normalized ratio <1.5 [0.85&#8211;1.25] or platelet count <80,000/mm3 [150,000&#8211;450,000/mm3])
2) the inability to sample the lesion because of the presence of intervening blood vessels or altered gastrointestinal anatomy

Target sample size

116


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jong Ho Moon

Organization

SoonChunHyang University School of Medicine, Bucheon

Division name

Digestive Disease Center and Research Institute, Department of Internal Medicine

Zip code


Address

Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital,

TEL

+82-32-621-5094

Email

jhmoon@schmc.ac.kr


Public contact

Name of contact person

1st name
Middle name
Last name Yun Nah Lee

Organization

SoonChunHyang University School of Medicine

Division name

Digestive Disease Center and Research Institute, Department of Internal Medicine

Zip code


Address

Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital,

TEL

+82-32-621-5094

Homepage URL


Email

yunnah@schmc.ac.kr


Sponsor or person

Institute

SoonChunHyang University School of Medicine, Bucheon

Institute

Department

Personal name



Funding Source

Organization

SoonChunHyang University School of Medicine, Bucheon

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Republic of Korea


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

Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon, Korea


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 31 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

Terminated

Date of protocol fixation

2012 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2013 Year 08 Month 30 Day

Date of closure to data entry

2013 Year 09 Month 03 Day

Date trial data considered complete

2013 Year 09 Month 20 Day

Date analysis concluded

2013 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 10 Month 13 Day

Last modified on

2013 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014057


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name