UMIN-CTR Clinical Trial

Basic information
Public title	Safety of colonoscopic therapy under continuance of warfarin
Acronym	Safety of colonoscopic therapy with warfarin
Scientific Title	Safety of colonoscopic therapy under continuance of warfarin
Scientific Title:Acronym	Safety of colonoscopic therapy with warfarin
Region	Japan

Condition
Condition	Colorectal polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Postoperative hemorrhage of colonoscopic therapy with warfarin are analyzed.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of postoperative hemorrhage until 4 months after intervention.
Key secondary outcomes	The rate of moderate-severe perioperative hemorrhage The rate of thromboembolism The change of PT-INR

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Endoscopic threpy of colorectal polyps for patients with warfarin
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases with warfarin for thromboembolism
Key exclusion criteria	Cases with main organ dysfunction
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Zip code
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naohisa Yoshida
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Zip code
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5519
Homepage URL
Email	naohisa@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
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	京都府立医科大学附属病院(京都府)、京都府立北部医療センター(京都府)

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 09 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	Completed
Date of protocol fixation	2015 Year 11 Month 02 Day
Date of IRB	2015 Year 11 Month 02 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 04 Month 01 Day
Date analysis concluded	2017 Year 04 Month 01 Day

Other
Other related information	Patients recieving warfarin, who will receive colonoscopic surgery for colorectal polyps are recruited for this study. Main measurements of this study is therapeutic results including postoperative hemorrahge.

Management information
Registered date	2015 Year 11 Month 02 Day
Last modified on	2021 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022654