UMIN-CTR Clinical Trial

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

gastrointestinal submucosal lesions

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

rate of sampling, accuracy, and complication

Key secondary outcomes

Kind of used device

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Fukushima Medical University Aizu Medical Center

Institute

Department

Personal name

Organization

organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

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

Registered date

2014

Year

06

Month

28

Day

Last modified on

2015

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015871