UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial comparing conventional ESD versus ProKnife ESD with injective function for gastric lesions in porcine models
Acronym	P-ESD trial
Scientific Title	A randomized controlled trial comparing conventional ESD versus ProKnife ESD with injective function for gastric lesions in porcine models
Scientific Title:Acronym	P-ESD trial
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether local injection from a high-frequency knife is useful in gastric ESD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ESD procedural time
Key secondary outcomes	Mucosal incision time and speed, submucosal dissection time and speed, en bloc resection rate, complete resection rate, amount of submucosal local injective solution, number of times local injection needles were used, whether the operator changed, whether traction was used, safety endpoint: rate of adverse events (intraoperative perforation)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Standard treatment group (Group A): conventional ESD
Interventions/Control_2	Sstudy treatment group (Group B): ProKnife-ESD (P-ESD)
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	(1) Pseudo-lesions created on resected porcine gastric ESD model (2) Tumor diameter of 30 mm or more
Key exclusion criteria	(1) Lesions spreading to the pylorus and fossa
Target sample size	68

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	812-8582
Address	3- 1 - 1 Maidashi, Higashi-ku, Fukuoka
TEL	+81-92-642-5286
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	812-8582
Address	3- 1 - 1 Maidashi, Higashi-ku, Fukuoka
TEL	+81-92-642-5286
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
Tel	+81-92-642-5286
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	2021 Year 05 Month 28 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	68
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	2021 Year 05 Month 27 Day
Date of IRB	2021 Year 05 Month 28 Day
Anticipated trial start date	2021 Year 05 Month 28 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry	2021 Year 10 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 27 Day
Last modified on	2022 Year 05 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050615