UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020211 |
|---|---|
| Receipt number | R000023006 |
| Scientific Title | The usefulness of out-patients endoscopic resection using cold snare polypectomy : a randomized controlled trial |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2017/02/22 18:46:57 |
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Basic information
Public title
The usefulness of out-patients endoscopic resection using cold snare polypectomy : a randomized controlled trial
Acronym
The usefulness of cold snare polypectomy for the out-patients
Scientific Title
The usefulness of out-patients endoscopic resection using cold snare polypectomy : a randomized controlled trial
Scientific Title:Acronym
The usefulness of cold snare polypectomy for the out-patients
Region
| Japan |
Condition
Condition
Colonic polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare late bleeding rates between cold and hot snare polypectomy among the out-patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
late bleeding rate after polypectomy
Key secondary outcomes
Resection time. Endoscopic complete resection rate. bleeding rate of polyp size, polyp location, antithrombotic drug. negative cut end rate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cold snare polypectomy
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patients with colonic polyps which were subjected to endoscopic resection
2. The patients whose ECOG performance status should be 0 or 1
3. The patients with age 20 years old
4. The patients who gave written informed consent
Key exclusion criteria
1. The patients with serious underlying disorders
2. The patients that were determined to be inappropriate to participate in the study by the investigators
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suketo Sou |
Organization
Tobata Kyoritsu Hospital
Division name
Department of gastroenterology
Zip code
Address
2-5-1 Sawami Tobata-ku Kitakyuushu-city Fukuoka
TEL
093-871-5421
k.ohtsu0120@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensei Ohtsu |
Organization
Tobata Kyoritsu Hospital
Division name
Department of gastroenterology
Zip code
Address
2-5-1 Sawami Tobata-ku Kitakyuushu-city Fukuoka
TEL
093-871-5421
Homepage URL
k.ohtsu0120@gmail.com
Sponsor or person
Institute
Tobata Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Tobata Kyoritsu Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 15 | 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 | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 12 | Month | 19 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 15 | Day |
Last modified on
| 2017 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023006
