UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on the effectiveness and safety of endoscopic resection using Souten snare in gastric tumors
Acronym	Efficacy of endoscopic resection using Souten snare in stomach tumor
Scientific Title	Prospective study on the effectiveness and safety of endoscopic resection using Souten snare in gastric tumors
Scientific Title:Acronym	Efficacy of endoscopic resection using Souten snare in stomach tumor
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to assess the efficacy and safety of Souten snare in hybrid ESD of gastric tumor prospectively.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	procedure time, histological complete resection rate, curative resection rate, perforation rate, bleeding rate
Key secondary outcomes	required medical expenses

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Differentiated mucosal carcinoma without ulcer at 15mm or less
Key exclusion criteria	Lesions for which surgical resection is desired by preoperative diagnosis Patients who were judged not eligible for participation in this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Taiga Middle name Last name Chiyo
Organization	Kagawa University, Faculty of Medicine
Division name	Department of Gastroenterology and Neurology
Zip code	761-0793
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL	0878912156
Email	chiyo.taiga@kagawa-u.ac.jp

Public contact
Name of contact person	1st name Taiga Middle name Last name Chiyo
Organization	Kagawa university
Division name	Department of Gastroenterology and Neurology
Zip code	761-0793
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL	0878912156
Homepage URL
Email	chiyo.taiga@kagawa-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Japan
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kagawa university
Address	kita-gun miki-cho ikenobe
Tel	0878912156
Email	chiyo.taiga@kagawa-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	2018 Year 11 Month 21 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	57
Results	The curative resection rate of h-ESD was 89.5% (51/57). The total (h-ESD + ESD) curative resection rate was 94.7% (54/57). The mean procedure time was 21.2 (+/-16.5) minutes. One case of delayed bleeding occurred. Additional knives were applied in two cases.
Results date posted	2022 Year 12 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures	The primary endpoint was curative resection rate of h-ESD. A difficult snaring case due to unexpected poor submucosal lifting was rescued by conventional ESD (conversion to ESD rate). Secondary endpoints included procedure time, total (h-ESD + ESD) curative resection rate, use rate of knives other than a SOUTEN (excluding hemostats), intraoperative and postoperative perforation rate, intraoperative bleeding, and postoperative bleeding.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 12 Month 01 Day
Date of IRB	2019 Year 03 Month 29 Day
Anticipated trial start date	2019 Year 03 Month 29 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2018 Year 11 Month 21 Day
Last modified on	2022 Year 12 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039874