This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors. In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month. In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Anesthesia: Local (Novocaine, Lidocaine, Bupivacaine) Access: transcutaneous Navigation under CT control Cannulas are used: 22G 100 and 150 mm, the size of the electrode corresponds to the size of the cannula The starting power is 20W followed by steps of 10W every 2 minutes until the maximum power is reached, the maximum power is 60W. In order to prevent infectious complications, two-day antibiotic prophylaxis of Cefazolin (1g) is carried out 3 times a day In order to prevent skin burns with superficially located DFS, the skin is cooled during the procedure.
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO)
Moscow, Moscow Oblast, Russia
Comparison of safety assessment.
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
Time frame: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy
Overall Response Rate
Proportion of patients who have a partial or complete response to therapy
Time frame: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy
Duration of responce
The time from randomization to disease progression or death for patients who achieve complete or partial alleviation
Time frame: 3 years
Comparison of tumor necrosis based on MRI/CT
Proportion of tumor necrosis after therapy
Time frame: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy
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