UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025657
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hiro4884@med.kagawa-u.ac.jp

Sponsor
Institute Department of Gastroenterology,Ehime Rosai Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029514

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.