UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017031
Receipt number R000019749
Scientific Title Diagnosability of wet suction FNA technique for gastrointenstinal submucosal tumor
Date of disclosure of the study information 2015/04/08
Last modified on 2021/10/07 13:55:20

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Basic information

Public title

Diagnosability of wet suction FNA technique for gastrointenstinal submucosal tumor

Acronym

wet technique

Scientific Title

Diagnosability of wet suction FNA technique for gastrointenstinal submucosal tumor

Scientific Title:Acronym

wet technique

Region

Japan


Condition

Condition

gastrointenstinal submucosal tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

efficacy of wet suction FNA technique for gastrointenstinal submucosal tumor

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

A comparison between wet and dry suction FNA technique for gastrointenstinal submucosal tumor

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

Prevention

Type of intervention

Maneuver

Interventions/Control_1

first wet suction FNA technique, second dry suction FNA technique

Interventions/Control_2

first dry suction FNA technique, second wet suction FNA technique

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. patient with gastrointestinal SMT of more than 10mm
2. agreement of patient

Key exclusion criteria

1. the one that I cannot discontinue or convert that followed guideline among patients taking antithrombotic drugs
2. reject of patient
3. patient that was judged to be inappropriate by a doctor

Target sample size

26


Research contact person

Name of lead principal investigator

1st name Takuto
Middle name
Last name Hikichi

Organization

Fukushima Medical University Hospital

Division name

Department of Endoscopy

Zip code

960-1247

Address

1 Hikarigaoka, Fukushima

TEL

024-547-1586

Email

takuto@fmu.ac.jp


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Waragai

Organization

Division of Medicine, Fukushima Medical University School of Medicine

Division name

Department of Gastroenterology

Zip code

960-1247

Address

1 Hikarigaoka, Fukushima

TEL

024-547-1202

Homepage URL


Email

yw3041@fmu.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Division of Medicine, Fukushima Medical University School of Medicine, and Department of Endoscopy, Fukushima Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Gastroenterology, Division of Medicine, Fukushima Medical University School of Medicine

Address

1 Hikarigaoka, Fukushima

Tel

024-547-1202

Email

yw3041@fmu.ac.jp


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

2015 Year 04 Month 08 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

Preinitiation

Date of protocol fixation

2015 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 09 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

2015 Year 04 Month 03 Day

Last modified on

2021 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019749


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name