UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial for preventive efficacy of postpolypectomy bleeding using clipping
Title of the study (Brief title)	Clip study
Region	Japan

Condition
Condition	Colon polyp
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluatte preventive efficacy of postpolypectomy bleeding using clipping
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of hemorrhage after polypectomy in the clipping group and the non-clipping group.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Maneuver
Interventions/Control_1	clipping group postpolepectomy
Interventions/Control_2	non-clipping group postpolypectomy
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Polypectomy patients with polyp of smaller than 2cm in diameter polyps
Key exclusion criteria	1)Patients with bleeding endency(bleeding time>5 minites,platelet<50000) 2)Patients with severe complications(liver cirrhosis,Renal failure)
Target sample size	1000

Research contact person
Name of lead principal investigator	Mototsugu Kato
Organization	Hokkaido Univercity hospital
Division name	Division of endoscopy
Address	kita14jo nishi5cho-me,kita-ku,sSapporo city,Hokkaido,Japan
TEL
Email

Public contact
Name of contact person
Organization	Hokkaido univercity hospital
Division name	Division of Endoscopy
Address
TEL
Homepage URL
Email	kirennjai@yahoo.co.jp

Sponsor
Institute	Division of endoscopy,Hokkaido univercity hospital
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 01 Month 30 Day
Last modified on	2018 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008444