UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Local recurrence after cold forceps polypectomy for diminutive polyps
Title of the study (Brief title)	Local recurrence after CFP for diminutive polyps
Region	Japan

Condition
Condition	colorectal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the local recurrence rate after cold forceps polypectomy for diminutive polyps
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	local recurrence rate after cold forceps polypectomy
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	diminutive polyps of <5mm in cecum or rectum resected by cold forceps polypectomy
Key exclusion criteria	patients with a history of inflammatory bowel disease familial adenomatous polyposis patients who refuse to undergo endoscopic surveillance colonoscopy at 1 year after cold forceps polypectomy.
Target sample size	200

Research contact person
Name of lead principal investigator	Shinji Nagata
Organization	Hiroshima City Asa Citizens Hospital
Division name	Department of Endoscopy
Address	2-1-1 Kabe-minami, Asakita-ku, Hiroshima City, Japan
TEL	082-815-5211
Email	s-nagata@asa-hosp.city.hiroshima.jp

Public contact
Name of contact person	Kenjiro Shigita
Organization	Hiroshima City Asa Citizens Hospital
Division name	Department of Endoscopy
Address	2-1-1 Kabe-minami, Asakita-ku, Hiroshima City, Japan
TEL	082-815-5211
Homepage URL
Email	k-shigita@asa-hosp.city.hiroshima.jp

Sponsor
Institute	Hiroshima City Asa Citizens Hospital
Institute
Department

Funding Source
Organization	Self funding
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	2017 Year 08 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 16 Day
Anticipated trial start date	2017 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This is a prospective study aiming to reveal local recurrence rate of CFP underwent just in cecum or rectum.

Management information
Registered date	2017 Year 08 Month 18 Day
Last modified on	2017 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032845