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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031511
Receipt No. R000035978
Scientific Title The Efficacy and Safety of SB Knife Jr. for Colorectal Endoscopic Submucosal Dissection (ESD) -International Multicenter Prospective Observational Study of existing treatment-
Date of disclosure of the study information 2018/02/28
Last modified on 2019/07/12

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Basic information
Public title The Efficacy and Safety of SB Knife Jr. for Colorectal Endoscopic Submucosal Dissection (ESD)
-International Multicenter Prospective Observational Study of existing treatment-
Acronym SB-INT ESD study
Scientific Title The Efficacy and Safety of SB Knife Jr. for Colorectal Endoscopic Submucosal Dissection (ESD)
-International Multicenter Prospective Observational Study of existing treatment-
Scientific Title:Acronym SB-INT ESD study
Region
Japan Asia(except Japan) Europe

Condition
Condition Colorectal neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the feasibility and safety and short- and long-term clinical outcomes of colorectal ESD using SB knife Jr. in multicenter setting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes adverse events during the procedure (perforation)
Key secondary outcomes

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
18 years-old <=
Age-upper limit
99 years-old >
Gender Male and Female
Key inclusion criteria We aim to recruit 400 consecutive patients who will be performed ESD with SB knife Jr. for early colorectal neoplasms. Indications for colorectal ESD were based on the Criteria of Indications for Colorectal ESD proposed by the JGES guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Written informed consent for the inclusion in this study will be obtained from each patient prior to recruitment.
Key exclusion criteria - pregnancy
- age of less than 18
- failure to provide written informed consent
- Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Toshio
Middle name
Last name Kuwai
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Gastroenterology
Zip code 737-0023
Address 3-1 Aoyama-cho, Kure 737-0023 Japan.
TEL +81-823-22-3111
Email kuwai.toshio.ur@mail.hosp.go.jp

Public contact
Name of contact person
1st name Toshio
Middle name
Last name Kuwai
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Gastroenterology
Zip code 737-0023
Address 3-1 Aoyama-cho, Kure 737-0023 Japan.
TEL +81-823-22-3111
Homepage URL
Email kuwai.toshio.ur@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department

Funding Source
Organization NA
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 National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Address 3-1 Aoyama-cho, Kure 737-0023 Japan.
Tel +81823223111
Email kuwai.toshio.ur@mail.hosp.go.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 02 Month 28 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The primary outcome will be adverse events during the procedure.
Secondary outcomes will include the procedure time, resection rate (en bloc, histological complete and curative), adverse events after the procedure (delayed bleeding, delayed perforation, post-ESD stricture), recurrence rate (local and distant), and survival rate (overall and tumor-specific).

Management information
Registered date
2018 Year 02 Month 28 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035978

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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