UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015149 |
|---|---|
| Receipt number | R000017619 |
| Scientific Title | Efficacy of pre-clipping fixation endoscopic mucosal resection to achieve sufficient bulging and surgical margin-negative resection |
| Date of disclosure of the study information | 2014/09/13 |
| Last modified on | 2016/08/15 17:33:26 |
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Basic information
Public title
Efficacy of pre-clipping fixation endoscopic mucosal resection to achieve sufficient bulging and surgical margin-negative resection
Acronym
Pre-clipping fixation EMR
Scientific Title
Efficacy of pre-clipping fixation endoscopic mucosal resection to achieve sufficient bulging and surgical margin-negative resection
Scientific Title:Acronym
Pre-clipping fixation EMR
Region
| Japan |
Condition
Condition
Colon polyps
Classification by specialty
| Medicine in general | Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In performing endoscopic mucosal resection (EMR), accurate snaring and surgical margin-negative resection pathologically while maintaining an ample safety margin is very important in determining the post-resection treatment strategy. However, snare strangulation of an inadequate safety margin sometimes occurs with thermal denaturation, which makes it difficult to determine the surgical margins pathologically; furthermore, local recurrence sometimes occurs. The aim of this study is to evaluate the efficacy of pre-clipping EMR by which sufficient bulging, accurate snaring and surgical margin-negative resection are obtained.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of pathologically negative surgical margin of EMR between conventional EMR group and pre-clipping EMR group.
Key secondary outcomes
1. L/W ratio during EMR by EUS between conventional EMR group and pre-clipping EMR group.
2. The number of re-snaring between conventional EMR group and pre-clipping EMR group.
3. The procedure time of EMR between conventional EMR group and pre-clipping EMR group.
4. The procedure time of closing post-EMR site between conventional EMR group and pre-clipping EMR group.
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Three-point pre-clipping EMR to colorectal polyp
Interventions/Control_2
Conventional EMR to colorectal polyp
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Colorectal polyps those size are over 5 mm in diameter under 20mm in diameter
Key exclusion criteria
Colorectal polyps those size are under 5 mm in diameter.
Patients who are not obtained informed and consent by written and verbal form.
Target sample size
70
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
+81-87-891-2156
hiro4884@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kazunori Yamashita |
Organization
Ehime Rousai Hospital
Division name
Medical Affairs Division
Zip code
Address
13-27 Minamikomatsubara, Niihama, Ehime 792-8550, Japan
TEL
+81-897-33-6191
Homepage URL
ijikachou@ehimerosai.jp
Sponsor or person
Institute
Ehime Rousai Hospital
Kagawa university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
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 Kagawa university
愛媛労災病院 Ehime Rousai Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 13 | Day |
Last modified on
| 2016 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017619
