An interventional study of Oncoplastic Approach Excisional Breast Biopsy and Conventional Excisional Breast Biopsy in Neoplasm of Female Breast, Breast Neoplasms Diagnosis and Breast Diseases, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by Akdeniz University · Not applicable, Interventional, and Other
Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. However, primary lumpectomy subjects in these studies are mainly patients who have already received the diagnosis of malignancy before the surgery. There is not much comprehensive work reported for patients without the diagnosis of malignancy. In this regard, the investigators believe the intent of the innovative oncoplastic intervention to the breast is underestimated in terms of providing diagnosis simultaneously constituting the basic component of surgical treatment. Thus, the purpose of this prospectively planned study is to provide and investigate the outcomes of an evidence-based oncoplastic approach algorithm for excisional breast biopsies.
Excisional breast biopsy is one of the routine surgical interventions in general surgery clinics, implemented for clinical diagnosis of suspicious breast lesions. It is the diagnostic method of choice especially when fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or vacuum-assisted core biopsy as part of a non-invasive approach can not provide sufficient diagnostic efficiency for the diagnosis of non-palpable breast lesions. This invasive biopsy approach must be selectively tailored according to the nature of the lesion, either directly or as a second-stage procedure, necessarily, if a sufficiently precise diagnosis cannot be reached after practicing less-invasive protocols. By definition, basic difference from a segmental mastectomy or a lumpectomy is that excisional breast biopsy is a surgical procedure to remove suspicious breast tissue and a small amount of normal tissue around it only before the pathologic diagnosis is confirmed.
Prebiopsy localisation modalities like wire-guidance or radioisotope occult lesion localization (ROLL) are proven to reduce the rates of margin positivity at initial lumpectomies in breast cancer. Accomplishing the excision as a whole with a 1 cm layer of normal tissue around by means of an incision confined to possible mastectomy line, whilst preserving the skin if it is 1cm far away from the suspicious area and a three-dimensional marking on the specimen are considered to be general principles in conventional excisional breast biopsies. In the same way, another ground rule would be close collaboration with plastic and reconstructive surgery department, especially when significant relative breast volume loss is anticipated and defect should be restored using volume replacement methods or when the nipple and areola complex (NAC) is under threat. It is imperative that the patient be informed of the common risks and reasonable alternatives to the proposed treatment. For patients seeking additional advice on NAC disturbances it is important to keep in mind that the tattoo art might be an appealing suggestion; many consider tattooing as a practical complementary solution for sequela after reconstruction of Nipple-areolar complex.
On the other hand, in the vast majority of the cases the mainstay of treatment does not entail surgical resection of NAC or requisite volume replacement, but still there is debate as to whether surgeons should place parenchymal sutures to approximate the cut edges of the cavity walls. The rationale behind this debate is that closure of the tissue defect with direct suture approximation brings about a considerable heterogeneity when it comes to cosmetic parameters. Besides, in many cases, when not coupled with overlying skin dissection after probable dimples observed on the skin while knotting each suture, this modality is ended up too far off target to merit the highest degree of patient satisfaction. Fortunately, surgical algorithms for breast tumors have been refined a great deal in recent years with rapid developments and key technique definitions in the field of oncoplastic surgery and opinions favoring parenchymal sutures have been strengthened.
Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. However, primary lumpectomy subjects in these studies are mainly patients who have already received the diagnosis of malignancy before the surgery. There is not much comprehensive work reported for patients without the diagnosis of malignancy. In this regard, the investigators believe the intent of the innovative oncoplastic intervention to the breast is underestimated in terms of providing diagnosis simultaneously constituting the basic component of surgical treatment. Thus, the purpose of this prospectively planned study is to provide and investigate the outcomes of an evidence-based oncoplastic approach algorithm for excisional breast biopsies.
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Exclusion Criteria:
Oncoplastic Approach Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment
Procedure: Oncoplastic Approach Excisional Breast Biopsy · Other: Tezel Method of Breast Volume Measurement · Other: Cosmetic Assessment
- Conventional Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment
Procedure: Conventional Excisional Breast Biopsy · Other: Tezel Method of Breast Volume Measurement · Other: Cosmetic Assessment
Evidence based quadrant by quadrant oncoplastic algorithm reinforced with videoscopic applications for peripheral lesions.
Conventional Excisional Breast Biopsy
Tezel Method is a simple, accurate and non-invasive method of measuring differences in breast volume based on Archimedes' principle
Cosmetic Assessment with Harris scale graded by patient, surgeon and professional third party. A standardised photograph of front, side and mediolateral oblique views will be taken using a digital camera for professional third party observers.
Harris scale for the cosmetic result.
Patient, surgeon and professional third party observers rate cosmetic results (in terms of color, symmetry, contour and general cosmetic outcome) on a four-point scale: (4) excellent-treated breast nearly identical to untreated breast; (3) good-treated breast slightly different from untreated; (2) fair-treated breast clearly different from untreated but not seriously distorted; (1) poor- treated breast seriously distorted.
Time frame: 3 months
Surgical margin positivity for malignancy
Ultimate histopathologic diagnosis
Time frame: Approximately 2 weeks
Radiologic assessment of surgical margins
Specimen mammography: Applicable to mammographically depicted lesions only
Time frame: Intraoperatively assessed
Morbidity
Bleeding, hematoma, seroma, necrosis or infection after surgery.
Time frame: 3 months
Reoperations
Need for any reoperations whether morbidity or surgical margins related.
Time frame: 3 months
Breast Size
Unilateral breast volume measured with Tezel method to discriminate small (250 cc and less) vs. medium/large (\>250 cc) breasts; determine oncoplastic intervention level (I or II) after assessment of anticipated volume ratio of the resection specimen.
Time frame: Preoperatively assessed
Lesion Peripherality
Lesion peripherality along with the videoscopic application preference is decided after assessment of areolar diameter, distance between areolar margin and the skin projection of the central spot of the lesion together with the depth of the lesion; all of which are determinants for ease of access to resection area.
Time frame: Preoperatively assessed
Anticipated specimen volume
Preoperatively anticipated specimen volume according to radiologic investigation.
Time frame: Preoperatively assessed
Exact specimen volume
True volume of the excised breast tissue
Time frame: Intraoperatively assessed
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Akdeniz University