UMIN-CTR Clinical Trial

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