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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041789
Receipt No. 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 2020/09/14

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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
Email 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
Email taka1.katano@gmail.com

Sponsor
Institute Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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