UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010551 |
|---|---|
| Receipt number | R000012336 |
| Scientific Title | Usefulness of scissors forceps for endoscopic submucosal dissection of the colon:The randomized controlled trial by scissors forceps-type knife combination group and needle-knife-tip alone group |
| Date of disclosure of the study information | 2013/04/22 |
| Last modified on | 2019/04/26 09:55:17 |
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Basic information
Public title
Usefulness of scissors forceps for endoscopic submucosal dissection of the colon:The randomized controlled trial by scissors forceps-type knife combination group and needle-knife-tip alone group
Acronym
Efficacy of scissors forceps for endoscopic submucosal dissection of the colon:
Scientific Title
Usefulness of scissors forceps for endoscopic submucosal dissection of the colon:The randomized controlled trial by scissors forceps-type knife combination group and needle-knife-tip alone group
Scientific Title:Acronym
Efficacy of scissors forceps for endoscopic submucosal dissection of the colon:
Region
| Japan |
Condition
Condition
Colorectal tumor of more than 20mm in size,which invades to the mucosa or the submucosal layer slightly
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine the usefulness and safety of Clutchcutter as scissors forceps for colorectal ESD in this prospective study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
procedure time, en bloc rate by ESD
Key secondary outcomes
complication rate including perforation, bleeding.Procedure completion rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ESD using scissors forceps, Clutchcutter for Colorectal tumor
Interventions/Control_2
ESD using needle knife, Dual knife for Colorectal tumor
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal tumor of more than 20mm in size,which invades to the mucosa or the submucosal layer slightly
Key exclusion criteria
1) deep invasion of SM layer
2) abnormality of hemostatic function
3) significant organ failure cases
4)Case unable to get agreement of a patient
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kobara |
Organization
Faculty of Medicine, Kagawa University
Division name
Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-891-2156
kobara@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Yasuoka |
Organization
Faculty of Medicine, Kagawa University
Division name
Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-891-2156
Homepage URL
kobara@med.kagawa-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
Tel
0878985111
chosa@med.kagawa-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
香川大学医学部附属病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
96
Results
There is no difference between the two groups. Although there is no difference in the rates of simultaneous excision and intraoperative perforation in both groups, the average operation time (64.6 minutes vs. 81.1 minutes) is shorter in group D, and the rate of procedure completion (89% vs. 98%) tends to be higher in group CC.
Results date posted
| 2019 | Year | 04 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
none
Outcome measures
procedure completion rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 21 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012336
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