UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012080
Receipt No. R000014121
Scientific Title Assessment of safety after endoscopic mucosal resection of colorectal tumor in patients taking aspirin or other antithrombotic agents
Date of disclosure of the study information 2013/10/20
Last modified on 2013/10/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Assessment of safety after endoscopic mucosal resection of colorectal tumor in patients taking aspirin or other antithrombotic agents
Acronym Assessment of safety after endoscopic mucosal resection of colorectal tumor in patients taking aspirin or other antithrombotic agents
Scientific Title Assessment of safety after endoscopic mucosal resection of colorectal tumor in patients taking aspirin or other antithrombotic agents
Scientific Title:Acronym Assessment of safety after endoscopic mucosal resection of colorectal tumor in patients taking aspirin or other antithrombotic agents
Region
Japan

Condition
Condition colorectal tumor
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 assessment of safety of endoscopic mucosal resection of colorectal tumor uuder taking aspirin or antithrombotic agents
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes the probability of rebleeding
Key secondary outcomes the risk factor of bleeding

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
Medicine Maneuver
Interventions/Control_1 We perform endoscopic mucosal resection for pationts who take some form of antithrombotic drug.
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 -Patients on some form of antithrombotic therapy who underwent EMR of colorectal tumor.

-Patients from whom concents has been obtained to participate in this study, which has been approved by the ethics committee

-Other patients who are unfit for the study as determined by the attending physician
Key exclusion criteria Patients from whom concents has not been obtained to participate in this study, which has been approved by the ethics committee
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Kawai
Organization Tsuyama Chuo Hospital
Division name Department of Gastroenterology
Zip code
Address 1756 Kawasaki-Tsuyama-city, Okayama
TEL 0868-21-8111
Email daicawai@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Kawai
Organization Tsuyama Chuo Hospital
Division name Department of Gastroenterology
Zip code
Address 1756 Kwasaki-Tsuyama-city, Okayama
TEL 0868-21-8111
Homepage URL
Email daicawai@yahoo.co.jp

Sponsor
Institute Tsuyama Chuo Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 津山中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 20 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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 20 Day
Last modified on
2013 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014121

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.