UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021416 |
|---|---|
| Receipt number | R000024504 |
| Scientific Title | Endoscopic mucosal resection of colorectal polyp in anticoagulated patients |
| Date of disclosure of the study information | 2016/03/09 |
| Last modified on | 2018/03/29 00:06:28 |
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Basic information
Public title
Endoscopic mucosal resection of colorectal polyp in anticoagulated patients
Acronym
EMR in anticoagulated patients
Scientific Title
Endoscopic mucosal resection of colorectal polyp in anticoagulated patients
Scientific Title:Acronym
EMR in anticoagulated patients
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safeness of colonic EMR without a heparin bridge in anticoagulated patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
perioperative and postoperative bleeding
( until 30 days after procedure)
Key secondary outcomes
thromboembolism( until 30 days after procedure)
variables as bleeding risk factor
comparison between warfarin and DOAC
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
Colorectal EMR in anticoagulated patients
(until 30 days after procedure)
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
1) patients with colorectal polyp becoming the indication of EMR:
2) Under single use of anticoagulant agent
3) PT-INR is less than 2.6
4) Written Informed consent.
Key exclusion criteria
1) PT-INR is 2.6 or more
2) Under combination use of antiplatelet agents.
3) patients with severe organ failure (herat, liver,renal)
4) patients who have been judged as inappropriate for this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sayo Kobayashi |
Organization
Fukuyama City Hospital
Division name
Department of Internal medicine
Zip code
Address
5-23-1 Zao-cho Fukuyama-city Hiroshima
TEL
084-941-5151
sayo44@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayo Kobayashi |
Organization
Fukuyama City Hospital
Division name
Department of Internal medicine
Zip code
Address
5-23-1 Zao-cho Fukuyama-city Hiroshima
TEL
084-941-5151
Homepage URL
sayo44@hotmail.co.jp
Sponsor or person
Institute
Fukuyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okayama University Hospital, Okayama saiseikai General Hospital, Mitoyo General Hospital, Kagawa Prefectural Central Hospital, Okayama City Hospital, Tsuyama Chuo Hospital, Okayama Red Cross Hospital, Sumitomo Besshi Hospital, Himeji Red Cross Hospital, Hiroshima City Hospital, Fukuyama Medical Center,
Name of secondary funder(s)
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
福山市民病院（広島県）岡山大学病院(岡山県), 岡山済生会総合病院(岡山県), 三豊総合病院（香川県）, 香川県立中央病院（香川県）, 岡山市立市民病院(岡山県), 津山中央病院(岡山県), 岡山赤十字病院(岡山県), 住友別紙病院（愛媛県）, 姫路赤十字病院（兵庫県）, 広島市立広島市民病院（広島県）, 福山医療センター（広島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | 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
| 2016 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 09 | Day |
Last modified on
| 2018 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024504
