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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020826
Receipt No. R000024041
Scientific Title Efficacy of Multiple Polyp Catcher Tag(MPCT)during retrieval of resected polyps by EMR: Investigation of correct diagnosis of resected multiple polyps locations under 20mm in diameter
Date of disclosure of the study information 2016/02/01
Last modified on 2018/12/11

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Basic information
Public title Efficacy of Multiple Polyp Catcher Tag(MPCT)during retrieval of resected polyps by EMR: Investigation of correct diagnosis of resected multiple polyps locations under 20mm in diameter
Acronym Multiple Polyp Catcher Tag(MPCT)
Scientific Title Efficacy of Multiple Polyp Catcher Tag(MPCT)during retrieval of resected polyps by EMR: Investigation of correct diagnosis of resected multiple polyps locations under 20mm in diameter
Scientific Title:Acronym Multiple Polyp Catcher Tag(MPCT)
Region
Japan

Condition
Condition Multiple colonic polyps 8 to 20mm in diameter
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To date, after colorectal polyps 8-20 mm in diameter were resected by EMR,specimen were retrieved by net forceps through the scope channel. Therefore, if one or more polyps were found, we release the previously resected polyps and put the snare into the colon to perform EMR. After EMR, the net forceps was put into the resected site to retirieve the specimen again. This procedure make it impossible to diagnose the accurate location of resected polyps which are difficult to follow up the malignant potential lesions. As these polyps located in proximal colon and were similar shapes and similar sizes but the different locations, it was necessary to confirm accurate locations due to the possibilities of following additional EMR. We prepared 3 type of ring thread such as white, purple and black. After local injection was performed and obtained sufficient bulging, white ring thread 5 mm in diameter was put and fixed by clipping close to the 1st polyp. EMR was performed including the clip with white ring thread. Similarly, EMR were performed 2nd and 3rd polyps with purple and black ring thread, respectively.After all EMR had been performed completely, grasping forceps were inserted through the scope channel to hook and grasp ring threads to retrieve all the resected polyps.



Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The accuracy of resected polyps and resected locations.
Key secondary outcomes 1.The retrival time between Multiple polyp catcher tag (MPCT) and conventinal EMR.
2.The retrival rate without peicemeal resection

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Prepared 3 type of ring thread such as white, purple and black. After local injection was performed and obtained sufficient bulging, white ring thread 5 mm in diameter was put and fixed by clipping close to the 1st polyp. EMR was performed including the clip with white ring thread. Similarly, EMR were performed 2nd and 3rd polyps with purple and black ring thread, respectively. After all EMR had been performed completely, grasping forceps were inserted through the scope channel to hook and grasp ring threads to retrieve all the resected polyps
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 The inclusion criteria is the patients who are planned to be performed EMR with 2 and more polyps which cannot be retrieved by aspiration through the scope channel.
Key exclusion criteria The exclusion criteria is colorectal polyps: over 20 mm, sm massive lesion, indication of sugical removeal
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Mori
Organization Kagawa University
Division name Department of Gastroenterology and Neurology
Zip code
Address 1750-1, Miki, Kida, Kagawa, Japan
TEL 087-891-1256
Email hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukari Hayashi
Organization Ehime Rousai Hospital
Division name Medical Affairs Division
Zip code
Address 13-27, Minamikomatubara, Niihama, Ehime
TEL 0897-33-6191
Homepage URL
Email ijikachou@ehimerosai.jp

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization Ehime Ruosai Hospital
Organization
Division
Category of Funding Organization
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
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 愛媛労災病院、香川大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 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 Completed
Date of protocol fixation
2015 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 20 Day
Last follow-up date
2018 Year 11 Month 16 Day
Date of closure to data entry
2018 Year 12 Month 11 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 01 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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