UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041789 |
|---|---|
| Receipt number | R000047699 |
| Scientific Title | A prospective observational study post-double balloon endoscopy and -colorectal ESD for the incidental risk of deep vein thrombosis |
| Date of disclosure of the study information | 2020/09/14 |
| Last modified on | 2021/07/05 22:07:02 |
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Basic information
Public title
A prospective observational study post-double balloon endoscopy and -colorectal ESD for the incidental risk of deep vein thrombosis
Acronym
De-ViT study
Scientific Title
A prospective observational study post-double balloon endoscopy and -colorectal ESD for the incidental risk of deep vein thrombosis
Scientific Title:Acronym
De-ViT study
Region
| Japan |
Condition
Condition
superficial colorectal neoplasms, small intestinal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidental risk of deep venous thrombosis (DVT) after DBE and colorectal ESD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Each frequency of DVT for 30 days after DBE or colorectal ESD
Key secondary outcomes
(Each analysis for DBE or colorectal ESD)
Identification of the risk factor for DVT, frequency of pulmonary embolism (PE), adverse events, Assessment of conventional risk scores (Caprini, Padua and Wells scores), Establishment of the novel risk score
(Integrative analysis including DBE and colorectal ESD)
Identification of the risk factor for DVT, frequency of pulmonary embolism, adverse events, Assessment of conventional risk scores (Caprini, Padua and Wells scores), Establishment of the novel risk score
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who receive DBE for small intestinal diseases or colorectal ESD
2. Proof of no DVT with whole-leg ultrasonography or CT scan
3. 20-89 years old
4. Agreement with signed informed consent
Key exclusion criteria
1. No previous history of DVT and PE
2. Central venous access
3. History of brain stroke within 3 months
4. History of broken bones within 3 months
5. History of surgery under general anesthesia within 3 months
6. History of acute infection within 3 months
7. History of acute coronary syndrome within 6 months
8. Blood diseases including genetic or acquired coagulation abnormality
9. Severe heart failure, liver failure, renal failure and diabetes
10. Peripheral arterial and venous diseases
11. Leg skin diseases including infection, ulcer and other inflammation
12. Peripheral neuropathy
13. Performance status = 3, 4
14. Pregnancy
15. Mental disorders and dementia
16. Inappropriateness with physician's judgement
Target sample size
245
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Shimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
tshimura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Katano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
Homepage URL
taka1.katano@gmail.com
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Gastroenterology, Aichi Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
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
愛知医科大学病院（愛知県）、名古屋第二赤十字病院（愛知県）、春日井市民病院（愛知県）、岐阜県立多治見病院（岐阜県）、名古屋市立東部医療センター（愛知県）、豊川市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 14 | 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
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sample size: 75 cases for DBE, 170 cases for colorectal ESD
Management information
Registered date
| 2020 | Year | 09 | Month | 14 | Day |
Last modified on
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047699
| Research Plan | |
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| 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 |
