UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011783
Receipt number R000013721
Scientific Title The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study
Date of disclosure of the study information 2013/09/18
Last modified on 2013/09/17 18:30:54

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Basic information

Public title

The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study

Acronym

The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study

Scientific Title

The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study

Scientific Title:Acronym

The effectiveness and safety of endoscopic submucosal dissection using an overtube with check valve for early gastric cancer: multicenter study

Region

Japan


Condition

Condition

Early Gastric Cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to assess the efficacy of the overtube with the check valve (leakcutter) for collapse of stomach during the ESD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

En bloc resection rate

Key secondary outcomes

Curative resection rate
Procedure time: time from injection into
submucosa to completion
of dissection
Difficulty of procedure: measured by VAS
The rate of adverse events and complications


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

from January 30 2013 to March 31 2015

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

The cases with hiatus hernia (Makuuchi Classification A or B) among the cases of indication of ESD for early gastric neoplasia.

Key exclusion criteria

1, Patients with perforamance status of 4
2, Patients with prior gastrectomy
3, Patients with severe comorbidity.
4, Those patients who are not able to
understand written information.
5, Unsuitable patients for the entry
judged by investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichiro Sato

Organization

Toho University Ohashi Medical Center

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code


Address

2-17-6 Ohashi Mekuro-ku Tokyo, 153-8515

TEL

03-3468-1251

Email

kou08@oha.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichiro Sato

Organization

Toho University Ohashi Medical Center

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code


Address

2-17-6 Ohashi Mekuro-ku Tokyo, 153-8515

TEL

03-3468-1251

Homepage URL


Email

kou08@oha.toho-u.ac.jp


Sponsor or person

Institute

Toho University Ohashi Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Hospital Organization Osaka National Hospital
Syonai Amarume Hospital

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

東邦大学医療センター大橋病院 (東京都)Toho University Ohashi Medical Center
国立病院機構大阪医療センター (大阪府)National Hospital Organization Osaka National Hospital
庄内余目病院 (山形県)Syonai Amarume Hospital


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 18 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

Open public recruiting

Date of protocol fixation

2013 Year 06 Month 24 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 18 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

2013 Year 09 Month 17 Day

Last modified on

2013 Year 09 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013721


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name