UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008447
Receipt number R000009935
Scientific Title Randomized comparison test of aspiration needles to gastric submucosal tumors about availability and safety of Endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)
Date of disclosure of the study information 2012/07/17
Last modified on 2013/12/10 20:23:44

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Basic information

Public title

Randomized comparison test of aspiration needles to gastric submucosal tumors about availability and safety of Endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)

Acronym

Comparison test of EUS-FNA needles to gastric submucosal tumors

Scientific Title

Randomized comparison test of aspiration needles to gastric submucosal tumors about availability and safety of Endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)

Scientific Title:Acronym

Comparison test of EUS-FNA needles to gastric submucosal tumors

Region

Japan


Condition

Condition

gastric submucosal tumors

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to estimate two EUS-FNA needles about diagnostic efficacy and safety for the gastric submucosal tumors.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensitivity, specificity, accuracy and incidence of complication

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants 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

Randomized 10 cases are performed EUS-FNA with normal 22G needle.

Interventions/Control_2

Randomized 10 cases are performed EUS-FNA with 22G needle with side port.

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

the patients with gastric submucosal tumors and with indication of EUS-FNA

Key exclusion criteria

(1) Patients with bleeding tendency
(2) Patients under anticoaglant therapy
(3) Plt< 30000
(4) Tumor size < 2cm

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Watanabe Seitaro

Organization

Yokohama City University Hospital

Division name

Gstroenterology Division

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Watanabe Seitaro

Organization

Yokohama City University Hospital

Division name

Gastroenterology Division

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL


Homepage URL


Email



Sponsor or person

Institute

Yokohama City University, Gastroenterology Division

Institute

Department

Personal name



Funding Source

Organization

no

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

2012 Year 07 Month 17 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

2012 Year 07 Month 17 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 07 Month 16 Day

Last modified on

2013 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009935


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name