UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006754
Receipt number R000007986
Scientific Title Comparative study of tunneling bloc biopsy versus EUS-fine needle aspiration for GI subepithelial tumor (a prospective comparative study in the same case)
Date of disclosure of the study information 2011/11/23
Last modified on 2016/11/24 12:59:35

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Basic information

Public title

Comparative study of tunneling bloc biopsy versus EUS-fine needle aspiration for GI subepithelial tumor
(a prospective comparative study in the same case)

Acronym

Tunneling bloc biopsy for GI subepithelial tumor

Scientific Title

Comparative study of tunneling bloc biopsy versus EUS-fine needle aspiration for GI subepithelial tumor
(a prospective comparative study in the same case)

Scientific Title:Acronym

Tunneling bloc biopsy for GI subepithelial tumor

Region

Japan


Condition

Condition

Gastrointestinal submucosal tumor

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the usefulness and safety of a new biopsy method for SMT

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Immunohistological diagnostic ratio
complication rate

Key secondary outcomes

technical success rate
procedure time
biopsy frequency


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

tunneling bloc biopsy

Interventions/Control_2

EUS-FNAB

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Cases of tumor protruding in submucosa by EUS and CT imagings

Key exclusion criteria

extraluminal tumor

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Kobara

Organization

Kagawa Medical University

Division name

Department of Gastroenterology and Neurology

Zip code


Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793 Japan.

TEL

087-891-2156

Email

kobara@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Kobara

Organization

Kagawa Medical University

Division name

Department of Gastroenterology and Neurology

Zip code


Address

1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan

TEL

087-891-2156

Homepage URL


Email

kobara@med.kagawa-u.ac.jp


Sponsor or person

Institute

Kagawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Kagawa Medical University

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

2011 Year 11 Month 23 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

The study was a non-randomized, prospective comparative study with crossover design in patients with endoluminal gastric subepithelial lesions (SELs). Forty-three patients, including 29 cases with lesions <2 cm were enrolled. A crossover design with two intervention phases (Group A: EUS-guided fine needle aspiration (FNA) followed by STB for 23 SELs, Group B: STB followed by FNA for 20 SELs) was implemented. The primary outcome was the diagnostic yield (DY). Secondary outcomes were technical success rate, procedure time, complication rate, and sample quality.
Results: The DY of STB was significantly higher than that of FNA (100% vs. 34.8%) in group A, including 100% in overall STB. The technical success rate of STB was significantly higher than that of FNA (100% vs. 56.5%), whereas the median procedure time of STB was significantly longer than that of FNA (37 minutes vs. 18 minutes). The median specimen area of STB samples was markedly larger than that of FNA samples (5.54 mm2 vs. 0.69 mm2). No complications occurred in either method.
Conclusions: STB had significantly superior diagnostic ability and a more adequate sample quality than FNA for endoluminal gastric SELs, indicating the suitability of STB for small SELs.

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

2011 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 07 Day

Last follow-up date

2016 Year 10 Month 01 Day

Date of closure to data entry

2016 Year 10 Month 20 Day

Date trial data considered complete

2016 Year 10 Month 25 Day

Date analysis concluded

2016 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 11 Month 21 Day

Last modified on

2016 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name