UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017545 |
|---|---|
| Receipt number | R000020334 |
| Scientific Title | Efficacy and safety of cold polypectomy for colorectal polyps : a prospective randomized study |
| Date of disclosure of the study information | 2015/05/13 |
| Last modified on | 2018/05/15 10:30:32 |
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Basic information
Public title
Efficacy and safety of cold polypectomy for colorectal polyps : a prospective randomized study
Acronym
Efficacy and safety of cold polypectomy
Scientific Title
Efficacy and safety of cold polypectomy for colorectal polyps : a prospective randomized study
Scientific Title:Acronym
Efficacy and safety of cold polypectomy
Region
| Japan |
Condition
Condition
Colorectal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety, tolerability of patients, and recurrence rate after resection by cold polypectomy, compared to conventional electrocautery method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of delayed bleeding
Key secondary outcomes
The incidence of immediate bleeding and perforation, procedure time, tolerability of patients, endoscopical en bloc resection rate, recurrence rate, rate of advanced neoplasia, and cost of procedure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional polypectomy
Interventions/Control_2
Cold polypectomy
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) Endoscopically diagnosed as colorectal adenoma 6mm<= and <10mm
(2) 20 y.o. <=
(3) Written informed consent
Key exclusion criteria
(1) Patients with serious heart disease
(2) Patients with diseases that cause the bleeding tendency.
(3) Patients who have serious complications
(4) Pregnant
(5) 20 y.o.>
(6) Pedunculated lesion
(7) Others
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Ito |
Organization
Asahikawa-Kosei General Hospital
Division name
Department of gastroenterology
Zip code
Address
1-24-111,Asahikawa,Hokkaido
TEL
0166-33-7171
dr-ito@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Ito |
Organization
Asahikawa-Kosei General Hospital
Division name
Department of gastroenterology
Zip code
Address
1-24-111,Asahikawa,Hokkaido
TEL
0166-33-7171
Homepage URL
dr-ito@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa-Kosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
旭川厚生病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | 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
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2018 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020334
| 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 |
