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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020158
Receipt No. R000023285
Scientific Title Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)
Date of disclosure of the study information 2015/12/10
Last modified on 2018/12/11

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Basic information
Public title Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)
Acronym Efficacy of the ERTT
Scientific Title Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)
Scientific Title:Acronym 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
1st name
Middle name
Last name Mori Hirohito
Organization Kagawa university
Division name Department of Gastroenterology and Neurology
Zip code
Address 1750-1, Miki, Kida, Kagawa, Japan
TEL 087-891-1256
Email hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hayashi Yukari
Organization Ehime Rousai Hospital
Division name Medical Affairs Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2015 Year 12 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023285

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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