UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012163 |
|---|---|
| Receipt number | R000014209 |
| Scientific Title | Efficacy of prophylactic clipping for postpolypectomy bleeding: A multicenter randomized controlled trial |
| Date of disclosure of the study information | 2013/10/30 |
| Last modified on | 2014/05/07 09:26:42 |
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Basic information
Public title
Efficacy of prophylactic clipping for postpolypectomy bleeding: A multicenter randomized controlled trial
Acronym
Efficacy of prophylactic clipping for postpolypectomy bleeding
Scientific Title
Efficacy of prophylactic clipping for postpolypectomy bleeding: A multicenter randomized controlled trial
Scientific Title:Acronym
Efficacy of prophylactic clipping for postpolypectomy bleeding
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of prophylactic clipping for postpolypectomy bleeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postpolypectomy bleeding rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Colonoscopic polypectomy
Interventions/Control_2
Prophylactic clipping after colonoscopic 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
Patients with colorectal neoplasms considered an indication for colonoscopic polypectomy
Key exclusion criteria
Age under 20 years old.
Lesions larger than 20mm in diameter.
Lesions considered an indication for endoscopic submucosal dissection.
Poor condition (PS 2 or 3).
Continuous anticoagulant therapy (heparin bridge therapy).
Patients with principal organ dysfunction.
Patients disagree with the present clinical trial.
Target sample size
1080
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Tsujii |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
Homepage URL
http://www.med.osaka-u.ac.jp/pub/gh/research_jisyu.html
mt@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
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
大阪大学医学部附属病院（大阪府）、大阪府立成人病センター（大阪府）、大阪府立急性期・総合医療センター（大阪府）、大阪回生病院（大阪府）、大阪船員保険病院（大阪府）大手前病院（大阪府）、貝塚市民病院（大阪府）、市立池田病院（大阪府）、市立伊丹病院（兵庫県）、市立豊中病院（大阪府）、住友病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 29 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014209
