UMIN-CTR Clinical Trial

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
Email	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
Email	dr13037@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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
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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036297