UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021779
Receipt number R000025118
Scientific Title A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node
Date of disclosure of the study information 2016/04/05
Last modified on 2020/10/09 13:38:22

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Basic information

Public title

A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node

Acronym

A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node

Scientific Title

A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node

Scientific Title:Acronym

A prospective randomized cotrolled study comparing EUS sonopsy CY and 22G EUS-FNAB needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions and swelling lymph node

Region

Japan


Condition

Condition

solid pancreatic mass lesions and swelling lymph nodes

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is evaluating the efficacy of EUS sonopsy CY by comparing EUS sonopsy CY with 22G EUS-FNAB(EchoTip ProCore)needle.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

The tissue collection rate and accuracy rate in each group.

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

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

In EUS-FNA, 1st and 3rd puncture using EUS sonopsy CY, 2nd and 4th puncture using 22GEUSFNAB needle(EchoTip Procore).

Interventions/Control_2

In EUS-FNA, 1st and 3rd puncture using 22GEUSFNAB needle(EchoTip Procore), 2nd and 4th puncture using EUS sonopsy CY.

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

Patients with pancreatic mass or swelling lymph node who are refered to EUS-FNA

Key exclusion criteria

1.Performance Status (PS)4.
2.The patient who has serious disease.
3.The pacient with anticoagulant therapy.
4.The woman becomes pregnant or might be pregnant.
5.Insertion of the endoscope is impossible.
6.The patient was judged the physician to be inappropriate.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi IRISAWA

Organization

Fukushima Medical University Aizu Medical Center

Division name

gastroenterology

Zip code


Address

21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City

TEL

(0242)75-2100

Email

irisawa@fmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryo IGARASHI

Organization

Fukushima Medical University Aizu Medical Center

Division name

gastroenterology

Zip code


Address

21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City

TEL

(0242)75-2100

Homepage URL


Email

ryo-i@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University Aizu Medical Center

Institute

Department

Personal name



Funding Source

Organization

Fukushima Medical University Aizu Medical Center

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

2016 Year 04 Month 05 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 05 Month 01 Day

Date of IRB

2015 Year 05 Month 01 Day

Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 05 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025118


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name