UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025052 |
|---|---|
| Receipt number | R000028832 |
| Scientific Title | Endoscopic ultrasonography-guided fine needle aspiration for patients taking anticoagulants without heparin bridging |
| Date of disclosure of the study information | 2016/11/29 |
| Last modified on | 2023/12/20 12:48:50 |
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Basic information
Public title
Endoscopic ultrasonography-guided fine needle aspiration for patients taking anticoagulants without heparin bridging
Acronym
EUS-FNA for patients with anticoagulants
Scientific Title
Endoscopic ultrasonography-guided fine needle aspiration for patients taking anticoagulants without heparin bridging
Scientific Title:Acronym
EUS-FNA for patients with anticoagulants
Region
| Japan |
Condition
Condition
EUS-FNA was expected
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of bleeding events
Key secondary outcomes
The rate of thromboembolism
The rate of other complications
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Taking anticoagulants
Key exclusion criteria
1.Platelets count less than 50000/m3
2. PT-INR more than 2.6
3. ASA more than 3
4. PS4
5. Severe bleeding tendecy
6. On hemodialysis
7. Cystic lesion
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
KIta15 Nishi7, Kita-ku, Sapporo
TEL
0117162111
kkawakubo-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
KIta15 Nishi7, Kita-ku, Sapporo
TEL
0117162111
Homepage URL
kkawakubo-gi@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Gastrointestinal Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028832
