UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025657 |
|---|---|
| Receipt number | R000029514 |
| Scientific Title | Efficacy of Proximal side Ring Thread Countertraction-Endoscopic Mucosal Resection (P-RTC-EMR) for colorectal polyps beyond colonic fold |
| Date of disclosure of the study information | 2017/01/13 |
| Last modified on | 2018/10/11 16:33:37 |
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Basic information
Public title
Efficacy of Proximal side Ring Thread Countertraction-Endoscopic Mucosal Resection (P-RTC-EMR) for colorectal polyps beyond colonic fold
Acronym
Proximal side Ring Thread Coutertraction-EMR(P-RTC-EMR)
Scientific Title
Efficacy of Proximal side Ring Thread Countertraction-Endoscopic Mucosal Resection (P-RTC-EMR) for colorectal polyps beyond colonic fold
Scientific Title:Acronym
Proximal side Ring Thread Coutertraction-EMR(P-RTC-EMR)
Region
| Japan |
Condition
Condition
Colorectal neoplastic polyps beyond a colonic fold 5 mm to 20 mm in diameter by narrow band imaging magnified endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is whether or not,complete resection of colorectal polyps beyond colonic folds is possible,shortening of procedure of endoscopic resection and sufficient treatment of post ER artificial ulcer by lifting up proximal side colonic mucosa using Proximal side Ring Thread Countertraction -EMR to put the lesion in front of endoscope.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome
Procedure time between Conventional EMR group and Proximal side Ring Thread Countertraction-EMR group
Key secondary outcomes
1.Bleeding during ER
2.Perforation rate during ER
3.Post ER bleeding from day1 to day14
4.Horizontal margin negative resection rate using P-RCT-EMR
5.Visibility of surgical field during ER by VAS score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In P-RCT-EMR group, ring thread 8-12mm in diameter with clip is placed in proximal side of the colon polyp and lifted up the proximal colonic mucosa to the contralateral side to place the lesion just in front of endoscope.
Interventions/Control_2
Conventional EMR
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 neoplastic polyps beyond a colonic fold 5 mm to 20 mm in diameter by narrow band imaging magnified endoscopy.
Key exclusion criteria
Colorectal polyps over 20 mm in diameter
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohito Mori |
Organization
Ehime Rosai Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-27, minami komatubara, niihama, Ehime
TEL
0897-33-6191
hiro4884@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohito Mori |
Organization
Ehime Rosai Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-27, minami komatubara, niihama, Ehime
TEL
0897-33-6191
Homepage URL
hiro4884@med.kagawa-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology,Ehime Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology,Kagawa University
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
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
79
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
| 2017 | Year | 01 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 13 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029514
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
