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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034533
Receipt No. 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 2019/06/07

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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 YES
Dynamic allocation YES
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
Institute Shonan Fujisawa Tokushukai Hospital
Institute
Department

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 Open public recruiting
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
2024 Year 03 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
2018 Year 10 Month 17 Day
Last modified on
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.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


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