UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031847 |
|---|---|
| Receipt number | R000036297 |
| Scientific Title | Efficacy of prophylactic clipping for post-polypectomy delayed bleeding. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/09/07 14:24:23 |
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Basic information
Public title
Efficacy of prophylactic clipping for post-polypectomy delayed bleeding.
Acronym
Efficacy of prophylactic clipping.
Scientific Title
Efficacy of prophylactic clipping for post-polypectomy delayed bleeding.
Scientific Title:Acronym
Efficacy of prophylactic clipping.
Region
| Japan |
Condition
Condition
Colon polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We prospectively investigate whether prophylactic clipping is effective in preventing bleeding after endoscopic colon polypectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of post-polypectomy bleeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
clipping group
Interventions/Control_2
non-clipping group
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) Those receiving endoscopic colon polypectomy at digestive endoscopy unit of Shiga University of Medical Science Hospital.
(2) Persons whose age is 20 years or older
(3) Those who can consent to participate in research by their own will
Key exclusion criteria
(1) Polyp more than 20 mm in diameter
(2) Pedunculated polyp more than 10 mm in diameter
(3) When bleeding or exposed blood vessels are seen immediately after polypectomy
(4) Persons with liver cirrhosis, blood disorders, dialysis patients, etc. and have blood platelet counts of 50,000 or less or PT-INR of 2.6 or more
(5) Those who are taking oral antithrombotic drugs and who are judged to be inappropriate for endoscopic polypectomy in accordance with the latest "endoscopic clinical practice guideline for antithrombotic drug recipients"
(6) Those who are taking oral antithrombotic drugs and who are in need of substitution of heparin for antithrombotic drugs in accordance with the latest "endoscopic clinical practice guideline for antithrombotic drug recipients"
(7) Person who is scheduled for MRI examination
(8) Those who refuse research cooperation
(9) Others who judged inappropriate by a doctor
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Takahashi |
Organization
Shiga University of Medical Science
Division name
Division of gastroenterology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2217
dr13037@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Takahashi |
Organization
Shiga University of Medical Science
Division name
Division of gastroenterology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2217
Homepage URL
dr13037@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 02 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036297
