UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034850 |
|---|---|
| Receipt number | R000039741 |
| Scientific Title | Prospective feasibility study investigating the efficacy and safety of SOUTEN for colorectal endoscopic submucosal dissection/precutting endoscopic mucosal resection |
| Date of disclosure of the study information | 2018/11/10 |
| Last modified on | 2018/11/10 13:15:00 |
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Basic information
Public title
Prospective feasibility study investigating the efficacy and safety of SOUTEN for colorectal endoscopic submucosal dissection/precutting endoscopic mucosal resection
Acronym
Efficacy and safety of SOUTEN for colorectal endoscopic submucosal dissection/precutting endoscopic mucosal resection
Scientific Title
Prospective feasibility study investigating the efficacy and safety of SOUTEN for colorectal endoscopic submucosal dissection/precutting endoscopic mucosal resection
Scientific Title:Acronym
Efficacy and safety of SOUTEN for colorectal endoscopic submucosal dissection/precutting endoscopic mucosal resection
Region
| Japan |
Condition
Condition
Colorectal 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 for colorectal hybrid ESD/precutting EMR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological complete resection rate
Key secondary outcomes
En bloc resection rate, curative resection rate, procedure time, intraoperative perforation rate, postoperative bleeding rate, delayed perforation rate, recurrence rate, and survival rate
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
Colorectal tumor that can not be resected en bloc by EMR
Key exclusion criteria
Colorectal tumor bigger than 50mm in size
Clinical T1 cancer diagnosed by preoperative exam
Patients who have been registered in this study
Patients who were judged not eligible for participation in this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Kuwai |
Organization
National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Division name
Gastroenterology
Zip code
Address
3-1 Aoyama-cho, Kure, Hiroshima
TEL
0823-22-3111
kuwait@kure-nh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuzuru Tamaru |
Organization
National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Division name
Gastroenterology
Zip code
Address
3-1 Aoyama-cho, Kure, Hiroshima
TEL
0823-22-3111
Homepage URL
tamaruy@kure-nh.go.jp
Sponsor or person
Institute
National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
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
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 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study about the usefulness and safety of colorectal hybrid ESD and precutting EMR using SOUTEN.
This is a single arm study.
The target objective is colorectal tumor that can not be resected en bloc by EMR.
Management information
Registered date
| 2018 | Year | 11 | Month | 10 | Day |
Last modified on
| 2018 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039741
