UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)
Title of the study (Brief title)	Efficacy of the ERTT
Region	Japan

Condition
Condition	The inclusion criteria of this study's patients who satisfied the following expanded indication inclusion criteria for ESD according to the guidelines of the Japan Gastric Cancer Association (JGCA) were included. In differentiated gastric cancers, intramucosal carcinoma has no size restriction, whereas intramucosal carcinoma accompanied by ulcer scar and SM1 carcinoma (500 um from the muscularis mucosae) should be <30 mm. In undifferentiated carcinomas, intramucosal carcinoma should be <20 mm. Included patients consented to the study after receiving oral and written explanations.
Classification by specialty	Medicine in general Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	During gastric endoscopic submucosal dissection, the clear surgical view is necessary to perform the procedure safely.Under clear view using ERTT enable us to perform ESD without bleeding and perforation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	The procedure time of ESD between ERTT group and conventionalgroup
Key secondary outcomes	1.Bleeding during ESD 2.The procerure time of creating ERTT 3.Evaluation of visibility of ERTT using VAS (visual analogue sysytem) score

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Innovative endoscopic counter traction method called ERTT which was made of surgical thread like ring-shaped thread
Interventions/Control_2	Conventional 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	20 years-old <=
Age-upper limit	89 years-old >
Gender	Male and Female
Key inclusion criteria	The inclusion criteria of this study's patients who satisfied the following expanded indication inclusion criteria for ESD according to the guidelines of the Japan Gastric Cancer Association (JGCA) were included. In differentiated gastric cancers, intramucosal carcinoma has no size restriction, whereas intramucosal carcinoma accompanied by ulcer scar and SM1 carcinoma (500 um from the muscularis mucosae) should be <30 mm. In undifferentiated carcinomas, intramucosal carcinoma should be <20 mm. Included patients consented to the study after receiving oral and written explanations.
Key exclusion criteria	Patients who should be removed the lesion by operation
Target sample size	100

Research contact person
Name of lead principal investigator	Mori Hirohito
Organization	Kagawa university
Division name	Department of Gastroenterology and Neurology
Address	1750-1, Miki, Kida, Kagawa, Japan
TEL	087-891-1256
Email	hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person	Hayashi Yukari
Organization	Ehime Rousai Hospital
Division name	Medical Affairs Division
Address	13-27, Minamikomatsubara, Niihama, Ehime 792-8550, Japan
TEL	0897-33-6191
Homepage URL
Email	ijikachou@ehimerosai.jp

Sponsor
Institute	Kagawa university
Institute
Department

Funding Source
Organization	Ehime rousai hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2015 Year 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 10 Day
Anticipated trial start date	2015 Year 12 Month 10 Day
Last follow-up date	2018 Year 10 Month 01 Day
Date of closure to data entry	2018 Year 10 Month 19 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 10 Day
Last modified on	2018 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023285