Excisional Vacuum-Assisted Breast Biopsy

Study Overview
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Brief Summary
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The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).

Detailed Description
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Surgery is the current standard of care of breast lesions like the Ductal Carcinoma In Situ (DCIS) and the Atypical Ductal Hyperplasia (ADH). However, the survival benefit of surgical resection in patients with such lesions appears to be low, especially for ADH and low-grade DCIS where comorbidity of surgery and prior depression have been reported as important factors related to worse quality of life in these women. Patients with suspicious breast lesions (BIRADS>3) who are candidates for vacuum assisted breast biopsy will be prospectively select and enroll if the radiological lesion diameter is less than 15 mm. The investigators will select those patients in whom after an initial sequence of sampling (12 cores), and will check the complete macroscopic removal of the lesion (with radiograms of the biopsied part of the breast). Those patients (complete macroscopic removal, with real-time verification during the procedure) will be randomized into two groups. A first group of patients will finish the biopsy procedure after the first collection sequence (12 cores, 3 grams of tissue taken and complete macroscopic removal). A second group of patients (randomized subdivision) will undergo a second sequence of biopsy samples (other 4 cores and 1 gram of tissue taken) in the same session: the material collected will be sent separately to the pathologist.

Official Title
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Excisional Vacuum-Assisted Breast Biopsy (VAE): Application to Avoid Surgery in Atypical Ductal Hyperplasia and Low/Intermediate Grade Ductal Carcinoma in Situ of the Breast

Conditions
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Atypical Ductal Hyperplasia, Ductal Carcinoma in Situ

Intervention / Treatment
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* Procedure: Vacuum-assisted excisional biopsy
* Procedure: Not excisional biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with suspicious breast lesions (BIRADS >3) Patients with a lesion <= of 15mm. Capable and willing to comply the specific informed consent form Patients with ADH biopsy results or low intermediate-grade DCIS Patients who will undergo surgery Exclusion Criteria: - Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: no excisional biopsy<br>Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled) | Procedure: Not excisional biopsy<br>* biopsy with less than 4 g of tissue sampled<br>|
| Experimental: excisional biosy<br>Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled) | Procedure: Vacuum-assisted excisional biopsy<br>* at least 4g of tissue sampled (excisional biopsy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with complete removal of lesion | Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups | 6 months |