UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000010551
Receipt No. 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 (Ver. 5)

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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
Last 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
Email kobara@med.kagawa-u.ac.jp

Public contact
1st 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
Email kobara@med.kagawa-u.ac.jp

Sponsor
Institute Faculty of Medicine, Kagawa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012336