UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018655 |
|---|---|
| Receipt number | R000019519 |
| Scientific Title | Colorectal EMR and ESD on continuous use of anticoagulants. |
| Date of disclosure of the study information | 2015/08/12 |
| Last modified on | 2018/08/15 07:25:08 |
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Basic information
Public title
Colorectal EMR and ESD on continuous use of anticoagulants.
Acronym
Colorectal EMR and ESD on continuous use of anticoagulants.
Scientific Title
Colorectal EMR and ESD on continuous use of anticoagulants.
Scientific Title:Acronym
Colorectal EMR and ESD on continuous use of anticoagulants.
Region
| Japan |
Condition
Condition
1. Patinets taking anticoagulants because of thrombotic risk (CHADS2 score more than 2 or mechnical valve replacement)
2. Colorectal polyps more than 5mm in diameter
3. Within 3 polyps can be resected in one procedure
4. Over 20 years old
5. PS(ECOG)0, 1, 2
6. patients without severe anemia, moderate to severe thrombocytopenia, severe liver dysfunction and severe renal dysfunction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety of endoscopic resection for colorectal polyps with ontinuous use of anticoagulants
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Lower gastrointestinal hemorrhage after endoscopic resetion
Key secondary outcomes
Hemorrhage not related with endoscopic therapy, thrombotic complications, perforation, other complications.
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
| Medicine |
Interventions/Control_1
anticoagulant therapy
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
Patients with anticoagulant therapy (CHADS2 score ).
Colorectal polyps more than 5mm in diameter.
Patients without severe anemia, moderate to severe thrombocytopenia, severe liver dysfunction and severe renal dysfunction.
PS(ECOG) 0, 1, 2
Key exclusion criteria
Patients taking antithrombotic agents other than warfarin or NOAC.
Patients taking NSAIDs and not able to interrupt 7 days before endoscopic therapy and 28 days after therapy.
Female who are pregnant or lactating.
Patients who have psychiatric disease.
patients who have active bacterial infection or fungal infection.
Patients with poor control hypertension(SBP more than 160mmHg or DBP more than 100mmHg).
Patients with chronic lung disease who need continuous oxygen therapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigetaka Tounou |
Organization
Teikyo University Chiba Medical Center
Division name
Division of Gastroenterology
Zip code
Address
3426-3 Anesaki, Ichihara City, Chiba
TEL
0436-62-1211
s-tounou@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigetaka Tounou |
Organization
Teikyo University Chiba Medical Center
Division name
Division of Gastroenterology
Zip code
Address
3426 Anesaki, Ichihara City, Chiba
TEL
0436-62-1211
Homepage URL
s-tounou@med.teikyo-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology
Teikyo University Chiba Medical Center
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shin-Tokyo Hospital
Name of secondary funder(s)
Bristol-Myers Squibb
IRB Contact (For public release)
Organization
Address
Tel
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
帝京大学ちば総合医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 12 | 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
Colorectal EMR for colorectal polyps under continuous use of warfarin was thought to be safer than heparin bridge therapy.
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 | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational study to confirm the safety of endoscopic therapy for colorectal polyps in patients with continuous use of anticoagulants.
Management information
Registered date
| 2015 | Year | 08 | Month | 12 | Day |
Last modified on
| 2018 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019519
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
