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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012163
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email mt@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014209


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