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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Patients With Acute Lower Limb Deep Vein Thrombosis (DVT)
• Intervention / Treatment: Procedure: mechanical thrombectomy (PMT)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Lyu; Phone Number: 13917427119; Email: wwxxyyzz@263.net

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • RenJi Hospital
      • Contact: Lei Lyu; Phone Number: 13917427119; Email: wwxxyyzz@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1) Between the ages of 18 and 75; 2) Suffering from acute lower limb deep vein thrombosis (DVT) with a duration of less than 14 days from onset; 3) Thrombosis involving the iliac vein, femoral vein, or popliteal vein; 4) The patient has been diagnosed with tumors, including benign or malignant tumors, including surgical or conservative treatment; 5) Sign an informed consent form.

Exclusion Criteria:

• 1) Patients with a history of deep vein thrombosis of the same lower limb in the past; 2) Patients with plasma Cr levels greater than 180umol/L; 3) Patients with contraindications to thrombolytic drugs; 4) Patients with concomitant inferior vena cava thrombosis or simple calf intermuscular vein thrombosis; 5) Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc; 6) Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months; 7) Pregnant and lactating women; 8) Patients with a life expectancy of less than 6 months, or those with other diseases that may cause difficulty in testing or significantly shorten the patient's life expectancy (<1 year), including severe liver disease, cardiac insufficiency, etc; 9) Patients with autoimmune thrombotic disease; 10) Patients who are unable or unwilling to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Improved approach mechanical thrombectomy (PMT) group	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.
No Intervention: Traditional simple anticoagulant group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of PTS at 12 months after surgery	Villalta Rating at 12 months after surgery	1 year

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 23, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: Y031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No