UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of Hybrid ESD in ex vivo porcine stomach model study
Acronym	Hybrid ESD in ex vivo porcine stomach model study
Scientific Title	The efficacy of Hybrid ESD in ex vivo porcine stomach model study
Scientific Title:Acronym	Hybrid ESD in ex vivo porcine stomach model study
Region	Japan

Condition
Condition	Gatric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of snaring during submucosal dissection in gastric ESD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ESD Procedure time
Key secondary outcomes	The time of mucosal incision and submucosal dissection, en bloc/complete resection rate, perforation rate, the volume of injective solutions required during procedure

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Mock lesions with 10-15mm in diameter
Key exclusion criteria	None
Target sample size	64

Research contact person
Name of lead principal investigator	1st name Mitsuru Middle name Last name Esaki
Organization	Kyushu University
Division name	Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code	8128582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL	092-642-5286
Email	esaki_saiseikai@yahoo.co.jp

Public contact
Name of contact person	1st name Mitsuru Middle name Last name Esaki
Organization	Kyushu University
Division name	Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code	8128582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL	092-642-5286
Homepage URL
Email	esaki_saiseikai@yahoo.co.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Kyushu University
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	Kyushu University
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City
Tel	0926425286
Email	esaki_saiseikai@yahoo.co.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	2020 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	64
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	2020 Year 11 Month 20 Day
Date of IRB	2020 Year 11 Month 20 Day
Anticipated trial start date	2020 Year 11 Month 20 Day
Last follow-up date	2020 Year 11 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Other

Other related information

BACKGROUND Hybrid endoscopic submucosal dissection has been invented as an advance ESD technique. H-ESD may improve the treatment outcomes of gastric ESD compared with conventional ESD. AIMS To determine how snaring during submucosal dissection affected the treatment outcomes of gastric ESD using an ex vivo porcine model METHODS Mock lesions with 10-15mm in diameter were created in the porcine stomach. A total of 64 ESD cases were performed by 16 endoscopists; 32 cases with H-ESD and the other 32 cases with C-ESD. Primary outcomes was ESD procedure time. Secondary outcomes included en bloc / complete resection rate, perforation rate, each procedure time/speed for mucosal incision or submucosal dissection. Factors associated with the difficulty of ESD including longer procedure time, incomplete resection or perforation were investigated.

Management information
Registered date	2020 Year 11 Month 20 Day
Last modified on	2021 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048528