NCT06085495

Mechanical Thrombectomy for Acute Lower Limb Deep Vein Thrombosis in Tumor Patients

Clinical Comparative Study of Mechanical Thrombectomy and Simple Anticoagulation Therapy for Acute Lower Limb Deep Vein Thrombosis in Tumor Patients Under VTE Prevention and Control System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will conduct a prospective single blind controlled study on the clinical efficacy and safety indicators of 50 cancer patients with acute lower limb deep vein thrombosis (DVT). The patients were randomly divided into an experimental group (improved mechanical thrombectomy (PMT) group) and a control group (traditional simple anticoagulation group) using the "envelope method", with 25 cases each. After the end of treatment, clinical prognosis evaluations were conducted on the patient's vital signs, symptoms and signs, lower limb Doppler ultrasound examination, patient PTS score (Villalta score), quality of life score (QOL), etc. at 3, 6, and 12 months. Adverse events, the presence or absence of thrombus recurrence, and re surgical intervention were recorded. This study is expected to propose a new strategy for the treatment of acute DVT in cancer patients, thereby improving the overall level of VTE prevention and treatment.

Conditions

• Cancer Patients With Acute Lower Limb Deep Vein Thrombosis (DVT)

Interventions

Type	Name	Description
PROCEDURE	mechanical thrombectomy (PMT)	After the establishment of the pathway, Angiojet (Boco, USA) was used to infuse urokinase into the blood vessels of the thrombotic segment. After waiting for 15 minutes, mechanical thrombectomy was performed. After thrombectomy, the effectiveness of thrombectomy was evaluated through angiography. For residual thrombi, repeated thrombectomy was performed, with a maximum thrombectomy volume of 480ml. After thrombectomy, antegrade angiography of the dorsal vein of the foot was performed again. If iliac vein stenosis was found to be greater than 50%, Then, Mustang balloons (Boko, USA) that match the normal blood vessel diameter are used for dilation. If the residual stenosis after dilation is greater than 30%, Wallsten stents that match the normal blood vessel diameter are inserted (Boko, USA). After all operations are completed, a dorsalis pedis venography is performed again to evaluate the thrombus burden and calculate the immediate thrombus clearance rate and thrombus clearance level.

Timeline

• Start date: 2023-01-23
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2023-10-17
• Last updated: 2025-08-29

Locations

1 site across 1 country: China