UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016068 |
|---|---|
| Receipt number | R000018662 |
| Scientific Title | A prospective exploratory study on the safety of polypectomy/EMR of colon without cessation of warfarin |
| Date of disclosure of the study information | 2014/12/26 |
| Last modified on | 2017/01/19 23:02:27 |
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Basic information
Public title
A prospective exploratory study on the safety of polypectomy/EMR of colon without cessation of warfarin
Acronym
A prospective exploratory study on the safety of polypectomy/EMR of colon without cessation of warfarin
Scientific Title
A prospective exploratory study on the safety of polypectomy/EMR of colon without cessation of warfarin
Scientific Title:Acronym
A prospective exploratory study on the safety of polypectomy/EMR of colon without cessation of warfarin
Region
| Japan |
Condition
Condition
colon polyps of patients who have non valvular atrial fibrillation and use warfarin for the prevention of thrombosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of polypectomy/EMR(Endoscopic Mucosal Resection) of colon without cessation of warfarin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The bleeding rate after polypectomy/EMR from immediately to the 28th day after polypectomy/EMR.
Key secondary outcomes
1.Early bleeding rate after polypectomy/EMR (from immediately after polypectomy/EMR to before the day2 meal starts)
2. Delayed bleeding rate after polypectomy/EMR (after the day2 meal has started)
3.Bleeding rate after polypectomy/EMR by the the tumor site and the major axis of tumor
4.The rate and number of blood transfusion for the bleeding during the polypectomy/EMR
5.The rate and number of blood transfusion for the bleeding after the polypectomy/EMR
6.PT-INR at the time of bleeding after polypectomy/EMR
7.Complications and the bleeding rate after polypectomy/EMR
8.Length of hospitalization
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 |
Interventions/Control_1
In patients who have non valvular atrial fibrillation and use warfarin for prevention of thrombosis, colorectal polypectomy/EMR wil be performed without cessation of warfarin.
Protocol treatment period in this study is from the day of polypectomy/EMR(day0) to the 28th day after polypectomy/EMR(day28). Observation period is from the registration to the protocol to the end of protocol treatment period.
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 non valvular atrial fibrillation, and use warfarin for prevention of thrombosis. Patients' PS (Performance Status) is 0-2 of ECOG(Eastern Cooperative Oncology Group), and over 20 years old age. The target is colorectal polyp that is indicated in polypectomy or EMR in Japanese colon polyp practice guidelines 2014.
(1)In blood collection within 3days before the treatment, PT-INR has to be confirmed following values.
Less than 70 years of age:PT-INR is less than 3
70 years of age or older: PT-INR is less than 2.6
(2)CCr is confirmed greater than or equal to 50mL/min(Cockcroft-Gault Equation) at the day before treatment.
(3)After the patient himself has received a sufficient explanation on participation in this study, informed consent has been obtained by the free will of the patient him or herself.
(4)It is possible to follow the course of more than 28 days after treatment.
(5)All the following test data using the latest test values within 30 days prior to registration is met.
a)Hb is 9g/dl or more
b)Plt is 100000/mm3 or more
c)AST, ALT is less than 100IU/L
d)APTT is less than 40sec
Key exclusion criteria
(1)CCr is less continuously 50mL/min (Cockcroft-Gault Equation)
(2)Woman who has a possibility of pregnancy or is during pregnancy
(3)Woman who nurses her baby
(4)Patients who undergo hemodialysis
(5)To assess the general condition and complications of patients, if the attending physician has determined that it is difficult to entry.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ono |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
satoshi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itaru Saito |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
isaitou-nms@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital Department of Gastroenterology, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
This study will be performed with medical care insurance. The clinical research insurance will be covered by donation (donation number 104-41).
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
石川県立中央病院(石川県)、茨城県立中央病院(茨城県)、大阪府立急性期・総合医療センター(大阪府)、静岡県立静岡がんセンター(静岡県)、千葉西総合病院(千葉県)、筑波学園病院(茨城県)、新潟県立中央病院(新潟県)、日立総合病院(茨城県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 26 | 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
| 2014 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 26 | Day |
Last modified on
| 2017 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018662
