UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study for Cold polypectomy
Title of the study (Brief title)	Cold polypectomy PI/II
Region	Japan

Condition
Condition	Colorectal polyp <10mm
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and efficacy of cold polypectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	PI: Incidence of tumor residue in the additional resection. PII: Cumulative delayed bleeding rate
Key secondary outcomes	PI: Incidence of spurting bleeding just after cold polypectomy. Incidence of intra-operative bleeding after EMR. R0 resection rate in cold polypectomy. adverse events. PII: Incidence of immediate bleeding. Hemostasis during colonoscopy. R0 resection rate. adverse events. Procedure time.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cold polypectomy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 20 y.o. < 2) Patients undergoing colorectal polypectomy (polyps < 10mm) 3) Written Informed consent.
Key exclusion criteria	1) Polyps > 10mm 2) Patients with advanced cancer or hemorrhoid. 3) Patients with IBD, polyposis, known colon cancer. 4) Patients with anticoagulant or antiplatelet therapy. Patients with bleeding tendency. 5) Important organ failure. 6) Patient without informed consent. 7) others
Target sample size	310

Research contact person
Name of lead principal investigator	Yoji Takeuchi
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Gastrointestinal Oncology
Address	1-3-3 Nakamichi Higashinari-ku Osaka
TEL	06-6972-1181
Email	takeuti-yo@mc.preosaka.jp

Public contact
Name of contact person	Chikako Matsumoto
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Institutional Review Board
Address	1-3-3 Nakamichi Higashinari-ku Osaka
TEL	06-6972-1181
Homepage URL
Email	matsumotochi@opho.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases, Gastrointestinal Oncology
Institute
Department

Funding Source
Organization	None
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	2013 Year 06 Month 10 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 02 Month 12 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date	2015 Year 02 Month 28 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2016 Year 05 Month 01 Day

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

Management information
Registered date	2013 Year 06 Month 05 Day
Last modified on	2017 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012729