UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032803 |
|---|---|
| Receipt number | R000037349 |
| Scientific Title | Prospective, single-blind, randomized controlled trial on effectiveness of single balloon overtube for ESD performed right semicolon lesion. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2022/06/09 20:31:15 |
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Basic information
Public title
Prospective, single-blind, randomized controlled trial on effectiveness of single balloon overtube for ESD performed right semicolon lesion.
Acronym
SBOT study
Scientific Title
Prospective, single-blind, randomized controlled trial on effectiveness of single balloon overtube for ESD performed right semicolon lesion.
Scientific Title:Acronym
SBOT study
Region
| Japan |
Condition
Condition
early colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of using single balloon overtube during ESD of right semicolon lesion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
treatment time
Key secondary outcomes
Complications (perforation, bleeding)
En bloc resection rate
Operability failure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ESD with single balloon overtube
Interventions/Control_2
ESD without single balloon overtube
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients performed ESD for right semicolon lesion
Key exclusion criteria
patients with advanced colorectal cancer
After colon surgery
Patients with severe systemic disease(>ASA4)
Patients without informed consent
Patients already enrolled in the same study
Considered by a study physician to be inappropriate for any other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yoshizaki |
Organization
Saiseikai Nakatsu Hospital
Division name
gastroenterology
Zip code
530-0012
Address
2-10-39 Shibata, Kita-ku, Osaka 530-0012, Japan
TEL
06-6372-0333
yoshizak@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yoshizaki |
Organization
Saiseikai Nakatsu Hospital
Division name
gastroenterology
Zip code
530-0012
Address
2-10-39 Shibata, Kita-ku, Osaka 530-0012, Japan
TEL
06-6372-0333
Homepage URL
yoshizak@med.kobe-u.ac.jp
Sponsor or person
Institute
Saiseikai Nakatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Nakatsu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Nakatsu Hospital
Address
2-10-39 Shibata, Kita-ku, Osaka 530-0012, Japan
Tel
06-6372-0333
yoshizak@med.kobe-u.ac.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 | 06 | Month | 01 | 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 | 05 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037349
