UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045034 |
|---|---|
| Receipt number | R000051440 |
| Scientific Title | The efficacy and safety of Multi Loop Traction Device for colorectal ESD: a single center randomized control trial |
| Date of disclosure of the study information | 2021/08/02 |
| Last modified on | 2024/02/03 09:35:17 |
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Basic information
Public title
The efficacy and safety of Multi Loop Traction Device for colorectal ESD: a single center randomized control trial
Acronym
MLTD for colorectal ESD: RCT
Scientific Title
The efficacy and safety of Multi Loop Traction Device for colorectal ESD: a single center randomized control trial
Scientific Title:Acronym
MLTD for colorectal ESD: RCT
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospective analysis of the efficacy of safety of MLTD for colorectal tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
resection time (from the start of resection to the end of resection)
Key secondary outcomes
dissection speed, the rate of en bloc resection, the rate of R0, adverse event, hospitalization, resection time of each invasion depth, resection time of each location, intraoperative bleeding time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
normal colorectal ESD
Interventions/Control_2
colorectal ESD with MLTD
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
1:The planed patient with colorectal ESD 2:The size of tumor is from 20mm to 50mm in preoperative diagnosis 3:The invasion depth of tumor is mucosa in preoperative diagnosis 4The informed consent from the patient
Key exclusion criteria
1:Local recurrence lesion after endoscopic or surgical resection 2:The invasion depth is diagnosed submucosa in preoperative diagnosis 3:Performance status >3 4:Severe heart disease(>NYHA3),severe lung disease(the necessary of oxygen inhalation), severe liver disease(Child pugh grade C),severe renal failure (eGFR<30ml/min./1.73m2),5:psycho-neurologic disease,6:inappropriate for clinical test from doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Gastroenterology
Zip code
4801195
Address
Yazakokarimata
TEL
0561623311
mebi@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Gastroenterology
Zip code
480-1195
Address
Nagakute city, Yazakokarimata 1-1
TEL
0561623311
Homepage URL
mebi@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical university
Institute
Department
Personal name
Funding Source
Organization
none
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
Aichi medical university
Address
Yazakokarimata
Tel
0561623311
amu_ethics@aichi-med-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
| 2021 | Year | 08 | Month | 02 | 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
| 2021 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051440
