UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031511 |
|---|---|
| Receipt number | 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 14:19:08 |
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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
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
kuwai.toshio.ur@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035978
