A prospective observational study post-double balloon endoscopy and -colorectal ESD for the incidental risk of deep vein thrombosis

A prospective observational study post-double balloon endoscopy and -colorectal ESD for the incidental risk of deep vein thrombosis - De-ViT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041789

Enrollment

245

Registered

2020-09-14

Start date

2020-09-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

superficial colorectal neoplasms, small intestinal diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Each frequency of DVT for 30 days after DBE or colorectal ESD	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Countries

Japan

Contacts

Public ContactTakahito Katano

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

taka1.katano@gmail.com052-853-8211

Outcome results