UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012631
Receipt number R000014758
Scientific Title Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between needle with side reverse bevel and standard needle
Date of disclosure of the study information 2013/12/20
Last modified on 2016/12/21 13:37:25

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Basic information

Public title

Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between needle with side reverse bevel and standard needle

Acronym

Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between a needle with side reverse bevel and a standard needle

Scientific Title

Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between needle with side reverse bevel and standard needle

Scientific Title:Acronym

Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between a needle with side reverse bevel and a standard needle

Region

Japan


Condition

Condition

pancreatic tumor

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Comparison of diagnostic accuracy between a needle with side reverse bevel and a standard needle

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic accuracy

Key secondary outcomes



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

GroupA: Puncture the lesion on the first and the third time with Echo Tip Procore (side reverse beveled) needle , and on the second and the fourth time with Echo Tip Ultra (standard) needle.

Interventions/Control_2

GroupB: Puncture the lesion on the second and the fourth time with Echo Tip Procore (side reverse beveled)needle, and on the first and third with Echo Tip Ultra (standard) 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

1)Cases need histological or cytological diagnosis for treatment
2)Cases obtained written informed consent

Key exclusion criteria

1)Cases with high risk of puncturing cystic lesion
2)Cases with known bleeding disorders
3)Cases regarded by doctors as inappropriate for the enrollment for some reasons

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiro Kida

Organization

Kitasato University school of medicine

Division name

Gastroenterolgy

Zip code


Address

1-15-1 Kitasato Minami Sagamihara Kanagawa

TEL

042-778-8111

Email

m-kida@kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohisa Iwai

Organization

Kitasato University School of medicine

Division name

Gastroenterolgy

Zip code


Address

1-15-1 Kitasato Minami Sagamihara Kanagawa

TEL

042-778-8111

Homepage URL


Email

t-iwai@kitasato-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology Kitasato University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

N/A

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

2013 Year 12 Month 20 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

2013 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2016 Year 01 Month 30 Day

Date of closure to data entry

2016 Year 01 Month 30 Day

Date trial data considered complete

2016 Year 01 Month 30 Day

Date analysis concluded

2016 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 19 Day

Last modified on

2016 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name