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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000014410
Receipt No. R000015871
Scientific Title Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Date of disclosure of the study information 2014/06/28
Last modified on 2015/07/31

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Basic information
Public title Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Acronym Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Scientific Title Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Scientific Title:Acronym Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Region
Japan

Condition
Condition gastrointestinal submucosal lesions
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Previous report demonstrated endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) for gastrointestinal submucosal lesion (SML) is feasible and safe with high diagnostic yield. On the other hand, since it is difficult to perform EUS-FNA for small SML especially less than 15mm, almost small SMLs are observed without EUS-FNA. However, because SMLs include malignant lesions even though a tumor is small, it is desirable to perform EUS-FNA when possible. The aim of this study is to evaluate feasibility and safety of EUS-FNA using forward-viewing echoendoscope attached with a cap device to the tip of scope for the small SML.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of sampling, accuracy, and complication
Key secondary outcomes Kind of used device

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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.A patient having SMT less than 15mm.
2.When the whole lesion can be observed with the forward-viewing echoendoscope, and a puncture route is secured, and can puncture it safely.
3.When EUS-FNA brings the information that is important to the treatment choice of the patient.
4.After having received enough explanation about inspection,the patient that understood enough, and a document agreement was provided.
5.Performance status does not have the limit in particular.
Key exclusion criteria 1.Blood disorder (hemoglobin <7.0 g/dL or platelet <100000/uL)
2.Renal disease (blood BUN> 25 mg/dL or blood creatinine> 2.0 mg/dL)
3.Liver disease (Child Pugh score> 6)
4.Extension of the solidification time(for warfarin potassium internal use or cirrhosis,Under 70 years old PT-INR> 3.0, 70 years old or more PT-INR>2.6)
5.Case to have serious complications to other organs.More than the three of the ASA classification(the dialysis patient is excluded)
6.Case not to be provided of Informed consent
7.In addition, the patient who judged the examination medical attendant to be inappropriate as a subject
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akane Yamabe
Organization Fukushima Medical University Aizu Medical Center
Division name Gastroenterology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi., Aizuwakamatsu, Japan
TEL 0242-75-2100
Email akaneko@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akane Yamabe
Organization Fukushima Medical University Aizu Medical Center
Division name Gastroenterology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi., Aizuwakamatsu, Japan
TEL 0242-75-2100
Homepage URL
Email akaneko@fmu.ac.jp

Sponsor
Institute Fukushima Medical University Aizu Medical Center
Institute
Department

Funding Source
Organization organization
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
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
2014 Year 06 Month 28 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 Suspended
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Without intervention, be the observational studies using samples.
A study period is from March, 2014 to July, 2014.

Management information
Registered date
2014 Year 06 Month 28 Day
Last modified on
2015 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015871

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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