UMIN-CTR Clinical Trial

Basic information
Public title	Assistant skill in gastric endoscopic submucosal dissection using a Clutch Cutter
Acronym	Assistant skill in gastric endoscopic submucosal dissection using a Clutch Cutter
Scientific Title	Assistant skill in ESD with a Clutch Cutter
Scientific Title:Acronym	Assistant skill in ESD with a Clutch Cutter
Region	Japan

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

Objectives
Narrative objectives1	To determine how assistant skill level affected the technical outcomes of gastric ESD-C using an ex vivo porcine training model.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total procedure time
Key secondary outcomes	En bloc resection rate, complete procedure rate, perforation rate, and each procedure time/speed for mucosal incision or submucosal dissection.

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	All operators were gastrointestinal trainees with experience performing less than 20 ESD procedures. One assistant was defined as an expert who had experience in not only assisting but also operating in at least 50 ESD procedures. The remaining 2 assistants were defined as non-experts with experience in operating or assisting in no more than 10 ESD procedures.
Key exclusion criteria	None
Target sample size	32

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 Medicine
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	0926425286
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 Medicine
Zip code	812-8582
Address	3- 1 - 1 Maidashi, Higashi-ku
TEL	0926425286
Homepage URL
Email	esaki_saiseikai@yahoo.co.jp

Sponsor
Institute	Kitakyushu Municipal Medical Center
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	Kitakyushu Municipal Medical Center
Address	2-1-1 Bashaku Kokurakita-Ward Kitakyushu-City
Tel	093-541-1831
Email	byou-iryou-chiken01@kitakyu-cho.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 10 Month 05 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	32
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 10 Month 05 Day
Date of IRB	2019 Year 01 Month 31 Day
Anticipated trial start date	2020 Year 10 Month 05 Day
Last follow-up date	2020 Year 10 Month 05 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	This was a retrospective observational study.

Management information
Registered date	2020 Year 10 Month 05 Day
Last modified on	2021 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047944

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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