UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034533
Receipt number R000038933
Scientific Title Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia
Date of disclosure of the study information 2018/10/17
Last modified on 2020/04/20 23:07:41

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Basic information

Public title

Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia

Acronym

Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia

Scientific Title

Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia

Scientific Title:Acronym

Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia

Region

Japan


Condition

Condition

Early gastric cancer, Gastric adenoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of the S-O clip for gastric endoscopic submucosal dissection (ESD)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

ESD procedure time

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Traction-assisted ESD with S-O clip group

Interventions/Control_2

Conventional ESD group

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

94 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Histopathologically proven gastric cancer or adenoma that meets the absolute or expanded indication of ESD according to the Japanese gastric cancer treatment guideline 2018 (5th edition)
2)No gastrectomy and reconstructive surgery of gastric tube for esophageal cancer
3)Eastern Cooperative Oncology Group Performance Status ranges from 0 to 2
4)Written informed consent by the patient
5)Patient age between 20 and 94 years

Key exclusion criteria

1)Pregnant patients or with the possibility of the pregnancy
2)Lactating patients
3)Patients disqualified for this study by the physician

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Mitsuru
Middle name
Last name Nagata

Organization

Shonan Fujisawa Tokushukai Hospital

Division name

Department of Endoscopy

Zip code

253-0041

Address

1-5-1 TUJIDOUKANDAI FUJISAWA-SHI KANAGAWA JAPAN

TEL

0466-35-1177

Email

mitsuru10jp@yahoo.co.jp


Public contact

Name of contact person

1st name Mitsuru
Middle name
Last name Nagata

Organization

Shonan Fujisawa Tokushukai Hospital

Division name

Department of Endoscopy

Zip code

253-0041

Address

1-5-1 TUJIDOUKANDAI FUJISAWA-SHI KANAGAWA JAPAN

TEL

0466-35-1177

Homepage URL


Email

mitsuru10jp@yahoo.co.jp


Sponsor or person

Institute

Shonan Fujisawa Tokushukai Hospital

Institute

Department

Personal name



Funding Source

Organization

Shonan Fujisawa Tokushukai Hospital

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

Mirai Iryo Research Center

Address

1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan

Tel

03-3263-4801

Email

shimizu@mirai-iryo.com


Secondary IDs

Secondary IDs

YES

Study ID_1

TGE01105-008

Org. issuing International ID_1

Mirai Iryo Research Center

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

湘南藤沢徳洲会病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 17 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

Completed

Date of protocol fixation

2018 Year 10 Month 05 Day

Date of IRB

2018 Year 10 Month 05 Day

Anticipated trial start date

2018 Year 10 Month 17 Day

Last follow-up date

2019 Year 09 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 17 Day

Last modified on

2020 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038933


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name