UMIN-CTR Clinical Trial

Basic information
Public title	Safety and Efficacy of Cold Biopsy Forceps Polypectomy for Diminutive Colorectal Polyps
Acronym	Cold Biopsy for Diminutive Colorectal Polyps
Scientific Title	Safety and Efficacy of Cold Biopsy Forceps Polypectomy for Diminutive Colorectal Polyps
Scientific Title:Acronym	Cold Biopsy for Diminutive Colorectal Polyps
Region	Japan

Condition
Condition	Diminutive Colorectal Polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of cold biopsy forceps polypectomy for diminutive colorectal polyps.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	recurrence rate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with non-pedunculated colon polyps less than 5 mm.
Key exclusion criteria	Patients with inflammatory bowel disease and/or polyposis. Patients with malignant neoplasms.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Toshio Middle name Last name Kuwai
Organization	National Hospital Organization, Kure Medical Cancer Center and Chugoku Cancer Center
Division name	Department of Gastroenterology,
Zip code	7370023
Address	3-1 Aoyama-cho Kure, Hiroshima
TEL	0823-22-3111
Email	kuwait@kure-nh.go.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Matsumoto
Organization	Kure Medical Cancer Center and Chugoku Cancer Center
Division name	Department of Gastroenterology
Zip code	7370023
Address	3-1 Aoyama-cho Kure, Hiroshima
TEL	0823-22-3111
Homepage URL
Email	kuwait@kure-nh.go.jp

Sponsor
Institute	Department of Gastroenterology, Kure Medical Cancer Center and Chugoku Cancer Center
Institute
Department

Funding Source
Organization	National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NHO
Address	2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel	0357125050
Email	kenkyu2004@hosp.go.jp

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	2015 Year 01 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	503
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	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
Date of IRB	2014 Year 12 Month 20 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2019 Year 07 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multi-Institutional Cohort Study

Management information
Registered date	2014 Year 12 Month 16 Day
Last modified on	2019 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018574