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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000047725
Receipt No. R000053492
Scientific Title The feasibility of endoscopic submucosal dissection for gastric lesions larger than 5 cm; a retrospective multicenter study
Date of disclosure of the study information 2022/05/12
Last modified on 2022/05/11

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Basic information
Public title The feasibility of endoscopic submucosal dissection for gastric lesions larger than 5 cm; a retrospective multicenter study
Acronym The feasibility of ESD for gastric lesions larger than 5 cm
Scientific Title The feasibility of endoscopic submucosal dissection for gastric lesions larger than 5 cm; a retrospective multicenter study
Scientific Title:Acronym The feasibility of ESD for gastric lesions larger than 5 cm
Region
Japan

Condition
Condition Mucosal and submucosalgastric neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aimed to investigate the feasibility and safety of ESD for large gastric lesions more than 5 cm
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes En bloc resection rate
Key secondary outcomes curative resection rate, submucosal fibrosis during ESD, procedure time rate of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 gastric lesions more than 5 cm in diameter
Interventions/Control_2 gastric lesions less than 5 cm in diameter
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
99 years-old >=
Gender Male and Female
Key inclusion criteria All cases that gastric neoplasm is resected by endoscopic submucosal dissection
Key exclusion criteria All the cases with endoscopic features suggesting obvious deep submucosal-invading cancer
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Hideyuki
Middle name
Last name Chiba
Organization Omori Red Cross Hospital
Division name Gastroenterology
Zip code 143-8527
Address 4-30-1, Chuo, Ota-Ku, Tokyo
TEL 0337753111
Email h.chiba04@gmail.com

Public contact
Name of contact person
1st name Hideyuki
Middle name
Last name Chiba
Organization Omori Red Cross Hospital
Division name Gastroenterology
Zip code 143-8527
Address 4-30-1, Chuo, Ota-Ku, Tokyo
TEL 0337753111
Homepage URL
Email h.chiba04@gmail.com

Sponsor
Institute Omori Red Cross Hospital
Institute
Department

Funding Source
Organization non
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 Omori Red Cross Hospital
Address 4-30-1, Chuo, Ota-Ku, Tokyo
Tel 0337753111
Email h.chiba04@gmail.com

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
2022 Year 05 Month 12 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 3474
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
2022 Year 01 Month 05 Day
Date of IRB
2022 Year 05 Month 10 Day
Anticipated trial start date
2022 Year 01 Month 05 Day
Last follow-up date
2022 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 11 Day
Last modified on
2022 Year 05 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053492

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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