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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042512
Receipt No. R000048528
Scientific Title The efficacy of Hybrid ESD in ex vivo porcine stomach model study
Date of disclosure of the study information 2020/11/20
Last modified on 2020/11/20

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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 Unpublished

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 No longer recruiting
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

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
2020 Year 11 Month 20 Day


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

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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