UMIN-CTR Clinical Trial

Basic information
Public title	Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study
Acronym	Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study
Scientific Title	Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study
Scientific Title:Acronym	Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study
Region	Japan

Condition
Condition	early gastric neoplasia
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	we conducted a retrospective study with the aim of verifying the predictors for gastric ESD that can be safely performed even with beginner.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the predictors of lesions that meet all the conditions that ESD can be performed by a beginner, with a procedure time of 60 minutes or less, complete pathological resection, and no severe complications, and self-completed.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Early gastric cancer and gastric adenoma who underwent endoscopic submucosal dissection at Showa University Hospital from January 2015 to December 2021
Key exclusion criteria	Lesions whose histopathological diagnosis was other than gastric cancer or gastric adenoma
Target sample size	466

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Katagiri
Organization	Showa university hospital
Division name	Division of Gastroenterology, Department of Medicine
Zip code	1428666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8535
Email	katsushi@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Ataushi Middle name Last name Katagiri
Organization	Showa university hospital
Division name	Division of Gastroenterology, Department of Medicine
Zip code	1428666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	0337848535
Homepage URL
Email	katsushi@med.showa-u.ac.jp

Sponsor
Institute	Showa university
Institute
Department

Funding Source
Organization	Showa university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Tokyo

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Showa University Review Board
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel	03-3784-8129
Email	m-rinri@ofc.showa-u.ac.jp

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 09 Month 06 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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 06 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The lesions were divided into two groups according to ESD experience of operator as follows; the ESD beginner (EB) group (ESD experience < 50) and the ESD non-beginner (ENB) group (ESD experience > 50). Relationships between difficult ESD (having at least one of the following items; procedure time > 60 min, incomplete resection, change of operator, occurrence of severe complication) and clinicopathological findings of the lesion were analyzed.

Management information
Registered date	2022 Year 09 Month 06 Day
Last modified on	2022 Year 09 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055097