UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018568
Receipt number R000021491
Scientific Title A pilot study of feasibility of non-exposed endoscopic wall-inversion surgery (NEWS) for early gastric cancer
Date of disclosure of the study information 2015/08/06
Last modified on 2017/08/07 12:56:47

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Basic information

Public title

A pilot study of feasibility of non-exposed endoscopic wall-inversion surgery (NEWS) for early gastric cancer

Acronym

NEWS for early gastric cancer

Scientific Title

A pilot study of feasibility of non-exposed endoscopic wall-inversion surgery (NEWS) for early gastric cancer

Scientific Title:Acronym

NEWS for early gastric cancer

Region

Japan


Condition

Condition

early gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Feasibility and efficacy of nonexposed endoscopic wall-inversion surgery for possibly node-negative early gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

5-year disease-free survival rate

Key secondary outcomes



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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Nonexposed endoscopic wall-inversion surgery

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) Possibly node-negative early gastric cancer on preoperative diagnosis
2) Lesions which endoscopic resection may be difficult

Key exclusion criteria

1) Patients whom laparoscopic treatment may be difficult
2) pregnant (or possibly pregnant) women, or lactating women

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naohisa Yahagi

Organization

Keio University, School of Medicine

Division name

Division of Research and Development for Minimally Invasive Treatment, Cancer Center

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211

Email

ogotou-gi@keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Goto

Organization

Keio University, School of Medicine

Division name

Division of Research and Development for Minimally Invasive Treatment, Cancer Center

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-5363-3437

Homepage URL


Email

ogotou-gi@keio.jp


Sponsor or person

Institute

Keio University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology; MEXT

Organization

Division

Category of Funding Organization

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

2015 Year 08 Month 06 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

Terminated

Date of protocol fixation

2015 Year 08 Month 03 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 07 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 08 Month 06 Day

Last modified on

2017 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021491


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name