UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025125
Receipt number R000028889
Scientific Title A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
Date of disclosure of the study information 2016/12/30
Last modified on 2019/06/09 09:36:52

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Basic information

Public title

A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.

Acronym

A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.

Scientific Title

A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.

Scientific Title:Acronym

A randomized controlled trial comparing traction ESD with the S-O clip versus conventional 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 efficacy and safety of traction ESD with the S-O clip compared with conventional ESD in terms of procedure time for patients with gastric epithelial neoplasia

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

Adverse events(delayed bleeding/perforation), ESD procedure time according to the location of the lesion, the proficiency of the operator (trainee or expert)and the presence of ulcer findings; en bloc resection rate; complete en bloc resection rate; amount of submucosal injection


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

A: traction ESD with the S-O clip group

Interventions/Control_2

B: 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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven gastric adenoma or cancer, which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline 2014.
2) No gastrectomy and no reconstructive surgery of gastric tube for esophageal cancer.
3) Aged 20 years old or more.
4) ECOG performance status of 0, 1 or 2.
5) Predicted line of mucosal incision is not on the EG junction.
6) Predicted line of mucosal incision is not on the pylorus.
7) Follow up for 60 days after ESD.
8) Written informed consent.

Key exclusion criteria

1) Patients who are disqualified for this study by physicians
2) Patients with the possibility of the pregnancy or the pregnancy
3) Patients who are lactating

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Dai Hirasawa

Organization

Sendai Kousei Hospital

Division name

Department of Gastroenterology

Zip code


Address

Hirose-cho 4-15, Aoba-ku, Sendai city, Miyagi, Japan

TEL

022-222-6181

Email

hirasawa@sendai-kousei-hospital.jp


Public contact

Name of contact person

1st name
Middle name
Last name Rintaro Hashimoto

Organization

Sendai Kousei Hospital

Division name

Department of Gastroenterology

Zip code


Address

Hirose-cho 4-15, Aoba-ku, Sendai city, Miyagi, Japan

TEL

022-222-6181

Homepage URL


Email

rhashimoto@sendai-kousei-hospital.jp


Sponsor or person

Institute

Sendai Kousei Hospital

Institute

Department

Personal name



Funding Source

Organization

Sendai Kousei 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


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

仙台厚生病院


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 30 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

2016 Year 11 Month 30 Day

Date of IRB

2017 Year 02 Month 01 Day

Anticipated trial start date

2016 Year 12 Month 30 Day

Last follow-up date

2017 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 02 Day

Last modified on

2019 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028889