Cryotherapy in the Treatment of Desmoid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Desmoid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type PROCEDURE

The procedure involves general or peripheral anesthesia and percutaneous treatment under CT control with probes capable of forming ice spheres of up to 3 cm that will be used in sufficient number to treat the neoplasm completely.

Interventions

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Cryotherapy

The procedure involves general or peripheral anesthesia and percutaneous treatment under CT control with probes capable of forming ice spheres of up to 3 cm that will be used in sufficient number to treat the neoplasm completely.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No