UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000018359
Receipt number	R000021254
Scientific Title	A multicenter prospective comparative crossover trial of endoscopic ultrasound-guided fine-needle aspiration between with and without the needle stylet using with the 22 gauge fine-needle aspiration needle
Date of disclosure of the study information	2015/07/20
Last modified on	2018/07/23 08:39:52

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Basic information

Public title

A multicenter prospective comparative crossover
trial of endoscopic ultrasound-guided
fine-needle aspiration between with and
without the needle stylet using with the
22 gauge fine-needle aspiration needle

Acronym

Comparative crossover trial of EUS-FNA with
and without stylet

Scientific Title

Scientific Title:Acronym

Comparative crossover trial of EUS-FNA with
and without stylet

Region

Japan

Condition

Pancreatic solid masses detected by imaging examination

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate histological tissue acquisition rate, quality of tissue, accuracy between EUS-FNA with and without stylet

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

Accuracy

Key secondary outcomes

Cellularity of tissue obtained
Quality of tissue obtained
Adequate quality

Base

Study type

Interventional

Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Pseudo-randomization

Intervention

No. of arms

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

At first and third aspiration,EUSFNA
with stylet is
performed. At second and forth
aspiration, EUS-FNA without stylet is performed.

Interventions/Control_2

At first and third aspiration,EUSFNA
without stylet is performed. At second
and forth aspiration, EUS-FNA with stylet is performed.

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) Patients with solid pancreatic mass,
which can be punctured from stomach
or duodenum using 22G safely.
2) Patients consent to be included in the
study based on his/her own free will
after sufficient informing and
understanding of the study.

Key exclusion criteria

1) Cases in Perfomance status 4
2)Cases with sever complication in
other organs except original disease
(ASA classification more than 3)
3)Cases having impossibility of
cessation of anticoagulant
4)Cases with pregnancy or suspect of
pregnancy
5)Cases having difficulty in endoscopic
approach
6)Cases with definite diagnosis by
another biopsy
7) Cases having difficulty in
visualization of mass on EUS
8)Cases judged by principal investigator
to be inadequate as subjects

Target sample size

100

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Takao Itoi

Organization

Tokyo Medical University

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

6-7-1 Nishishijuku, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Email

itoitakao@gmail.com

Public contact

Name of contact person

1st name

Middle name

Last name Shuntaro Mukai

Organization

Tokyo Medical University

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

6-7-1 Nishishijuku, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Homepage URL

Email

maezora1031@yahoo.co.jp

Sponsor or person

Institute

Tokyo Medical University
Department of Gastroenterology and Hepatology

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

National Cancer Center Hospital
Endoscopy division

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2015 Year 07 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

2015 Year 07 Month 20 Day

Date of IRB

Anticipated trial start date

2015 Year 07 Month 20 Day

Last follow-up date

2017 Year 07 Month 20 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2015 Year 07 Month 20 Day

Last modified on

2018 Year 07 Month 23 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021254

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name