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Oncoplastic Approach to Excisional Breast Biopsies

Primary Purpose

Neoplasm of Female Breast, Breast Neoplasms Diagnosis, Breast Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oncoplastic Approach Excisional Breast Biopsy
Conventional Excisional Breast Biopsy
Tezel Method of Breast Volume Measurement
Cosmetic Assessment
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neoplasm of Female Breast focused on measuring Excisional breast biopsy, Oncoplastic surgery, Oncoplastic reconstruction, Breast conserving surgery, Tezel method of breast volume measurement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are decided to be suitable for excisional breast biopsy.
  • Nonpalpable breast lesions suspicious for malignancy where less-invasive approach like fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or vacuum-assisted core biopsy can not provide sufficient diagnostic efficiency for the diagnosis.
  • Palpable breast lesions when a sufficiently precise diagnosis cannot be reached after practicing less-invasive protocols.

Exclusion Criteria:

  • Patients who are decided to be suitable for mastectomy included protocols as the primary surgery.
  • Patients who have previously had breast surgery.
  • Patients who refused excisional breast biopsy.
  • Patients who do not want to be photographed for cosmetic evaluations.
  • Patients diagnosed with secondary suspicious breast lesions necessitating surgical intervention during the follow-up period.
  • Presence of probable multicentric lesions.
  • Refusal of the patient to participate in the study for any reason.
  • Aberrations in the normal development and involution of the breast
  • Injury or trauma history of the breast resulted in deformity.

Sites / Locations

  • Akdeniz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Evidence-based Oncoplastic Algorithm

Control

Arm Description

Oncoplastic Approach Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment

- Conventional Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical margin positivity for malignancy
Ultimate histopathologic diagnosis
Radiologic assessment of surgical margins
Specimen mammography: Applicable to mammographically depicted lesions only
Morbidity
Bleeding, hematoma, seroma, necrosis or infection after surgery.
Reoperations
Need for any reoperations whether morbidity or surgical margins related.
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.
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.
Anticipated specimen volume
Preoperatively anticipated specimen volume according to radiologic investigation.
Exact specimen volume
True volume of the excised breast tissue

Full Information

First Posted
May 18, 2015
Last Updated
February 27, 2019
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT02452333
Brief Title
Oncoplastic Approach to Excisional Breast Biopsies
Official Title
Oncoplastic Approach to Excisional Breast Biopsies: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akdeniz University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm of Female Breast, Breast Neoplasms Diagnosis, Breast Diseases, Deformity of Reconstructed Breast
Keywords
Excisional breast biopsy, Oncoplastic surgery, Oncoplastic reconstruction, Breast conserving surgery, Tezel method of breast volume measurement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evidence-based Oncoplastic Algorithm
Arm Type
Experimental
Arm Description
Oncoplastic Approach Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment
Arm Title
Control
Arm Type
Experimental
Arm Description
- Conventional Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment
Intervention Type
Procedure
Intervention Name(s)
Oncoplastic Approach Excisional Breast Biopsy
Intervention Description
Evidence based quadrant by quadrant oncoplastic algorithm reinforced with videoscopic applications for peripheral lesions.
Intervention Type
Procedure
Intervention Name(s)
Conventional Excisional Breast Biopsy
Intervention Description
Conventional Excisional Breast Biopsy
Intervention Type
Other
Intervention Name(s)
Tezel Method of Breast Volume Measurement
Intervention Description
Tezel Method is a simple, accurate and non-invasive method of measuring differences in breast volume based on Archimedes' principle
Intervention Type
Other
Intervention Name(s)
Cosmetic Assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Harris scale for the cosmetic result.
Description
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
Secondary Outcome Measure Information:
Title
Surgical margin positivity for malignancy
Description
Ultimate histopathologic diagnosis
Time Frame
Approximately 2 weeks
Title
Radiologic assessment of surgical margins
Description
Specimen mammography: Applicable to mammographically depicted lesions only
Time Frame
Intraoperatively assessed
Title
Morbidity
Description
Bleeding, hematoma, seroma, necrosis or infection after surgery.
Time Frame
3 months
Title
Reoperations
Description
Need for any reoperations whether morbidity or surgical margins related.
Time Frame
3 months
Title
Breast Size
Description
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
Title
Lesion Peripherality
Description
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
Title
Anticipated specimen volume
Description
Preoperatively anticipated specimen volume according to radiologic investigation.
Time Frame
Preoperatively assessed
Title
Exact specimen volume
Description
True volume of the excised breast tissue
Time Frame
Intraoperatively assessed

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are decided to be suitable for excisional breast biopsy. Nonpalpable breast lesions suspicious for malignancy where less-invasive approach like fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or vacuum-assisted core biopsy can not provide sufficient diagnostic efficiency for the diagnosis. Palpable breast lesions when a sufficiently precise diagnosis cannot be reached after practicing less-invasive protocols. Exclusion Criteria: Patients who are decided to be suitable for mastectomy included protocols as the primary surgery. Patients who have previously had breast surgery. Patients who refused excisional breast biopsy. Patients who do not want to be photographed for cosmetic evaluations. Patients diagnosed with secondary suspicious breast lesions necessitating surgical intervention during the follow-up period. Presence of probable multicentric lesions. Refusal of the patient to participate in the study for any reason. Aberrations in the normal development and involution of the breast Injury or trauma history of the breast resulted in deformity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cumhur Arıcı, Professor
Organizational Affiliation
Akdeniz University, General Surgery Department
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University Hospital
City
Antalya
Country
Turkey

12. IPD Sharing Statement

Citations:
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25519931
Citation
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Links:
URL
https://dx.doi.org/10.1007/s12282-018-0892-2
Description
Oncoplastic approach to excisional breast biopsies: a randomized controlled, phase 2a trial

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Oncoplastic Approach to Excisional Breast Biopsies

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