Cryotherapy in the Treatment of Desmoid Tumors

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Desmoid

Treatments: Procedure: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05091255

CRYODESMO

Details and patient eligibility

About

Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologic diagnosis of desmoid tumors
• age > 18 years
• abdominal and extra-abdominal desmoid tumors

Exclusion criteria

• contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
• retroperitoneal desmoid tumors
• age < 18 years

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

94 participants in 1 patient group

Patients

Experimental group

Treatment:

Procedure: Cryotherapy