UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038933