Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .

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Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures

Standard conservative breast surgery

Oncoplastic breast surgery

This non randomized study is a comparative study between standard conservative breast surgery and oncoplastic surgery as regard margin status and patient satisfaction.

This planned study was conducted on 70 female patients presented to our tertiary referral breast unit at Ain Shams University hospitals with breast cancer amid the period from September 2012 to May 2013 .

Every one of them signed an informed consent to partake in this study that was approved in a meeting held by the ethical committee on august 2012 at Ain Shams University. All patients sharing in the study received closed envelope before surgery in a randomized way in which the surgical technique is written either standard conservative surgery or oncoplastic surgery(Double Blind).

Our patients were partitioned into 2 equal groups: group A (35patients) who underwent standard conservative surgery, group B (35patients) who underwent oncoplastic surgery.

A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction

A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction Among Egyptian Females

Ain Shams University

Lecturer of General surgery

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)

doxorubicin

cyclophosphamide

4 cycles T: paclitaxel 175mg/m2 after 4 AC

paclitaxel

The surgery will be performed 30 days after the chemotherapy. The correlation between clinical, radiologic and pathologic response will be reported.

The oncoplastic surgery rate will be reported

Surgery

Maria Aparecida A Koike Folgueira, MD, PhD

The purpose of this study is to analyze gene expression signature and immunohistochemical markers associated with clinical and pathological response to neoadjuvant chemotherapy in locally advanced breast cancer.

Locally advanced breast cancer is a common condition in development countries. Neoadjuvant chemotherapy gives the opportunity to identify genetic signatures associated with objective clinical and pathological complete responses.

Patients will receive doxorubicin/cyclophosphamide with paclitaxel. Tumor samples collected before and after chemotherapy will be analyzed.

Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Clinical and radiological examinations to be performed before chemotherapy, after the 4 cycle of AC and before surgery.

Pathologic evaluation to be performed 30 days after the last cycle of chemotherapy, i.g. after surgery.

tumor concordance measurement among pre-operative physical examination (PE), mammography (MG), ultrasound (US), breast MRI and post-operative pathologic measurement concordance with PE, MG, US and MRI

The use and security of oncoplastic surgery after neoadjuvant chemotherapy

Pathologic complete response after neoadjuvant chemotherapy

University of Sao Paulo

Barretos Cancer Hospital

Symptoms and General Pathology

Necrosis

All women operated on in the breast unit who require a reduction mammoplasty, a skin-sparing mastectomy (or skin and nipple) with immediate reconstruction and local flaps for remodeling or implant coverage.

* A first injection with the patient asleep before starting the intervention to visualize the vascular anatomy of each patient and assess the pedicles and incisions.
* A second bolus after breast resection to assess the viability of skin flaps and glandular pedicles.
* A third injection to obtain an angiography after implant placement and wound closure.

For angiography, the SPY System with the SPY-Q software will be used.

ICG angiography

Benigno Acea Nebril, MD PhD

Alejandra García Novoa, MD PhD

During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy there is a significant loss in the perfusion of the cutaneous envelope of the breast, which can produce areas of vascular suffering of the skin that sometimes cause necrosis of the same. Skin necrosis is the most important adverse event in oncoplastic and reconstructive surgery of the breast, since it causes delays in adjuvant treatments to surgery, worsening of the cosmetic result, and, on occasions, loss of the implant and reconstruction.

Indocyanine color green (ICG) angiography has been proposed as a diagnostic alternative to determine the vascular perfusion of the skin envelope of the breast during surgery, which would allow the removal of tissue at risk of necrosis to avoid this complication during the postoperative period. However, the scientific literature does not currently allow an adequate assessment of this diagnostic procedure due to the absence of prospective studies that have evaluated its sensitivity, specificity, and predictive values.

The objective of this prospective study is to evaluate ICG angiography of skin flaps of the breast and the surgeon's decision in women with breast cancer or at high risk for breast cancer undergoing oncoplastic surgery or mastectomy with the help of skin or skin-nipple. Based on the results of this study, the sensitivity, specificity, and predictive values of this technique for the prediction of adverse events during the postoperative period will be established.

Currently, surgery is a decisive therapeutic element in the management of women with breast cancer and at high risk for breast/ovarian cancer. In the first scenario, oncological surgery has evolved towards more complex technical procedures, such as oncoplastic surgery or skin-nipple-sparing mastectomies. These procedures have improved the quality of breast conservation or breast reconstruction, but have also increased the incidence of postoperative complications. In the second scenario, risk reduction mastectomies also share this same problem with an increase in adverse events after the use of ultra-conservative mastectomies. Without a doubt, skin necrosis is the most significant adverse event during the postoperative period in these patients due to three reasons. The first focuses on patients with breast cancer in whom skin necrosis delays the start of adjuvant treatments to surgery, chemotherapy or radiotherapy, causing greater complexity in their care process. Secondly, a significant number of these women with skin necrosis will require a second surgery to close the defect in the skin coverage, generally using a local flap, increasing care saturation and healthcare costs. Finally, these skin necrosis generate anatomical defects that in many cases will lead to cosmetic sequelae, worsening satisfaction and quality of life in this group of women. These consequences are especially relevant in women with prepectoral breast reconstruction, since the absence of muscle between the skin and the implant facilitates the exposure of the latter and, on occasions, the loss of the reconstruction.

During the last 15 years our unit has published various articles analyzing adverse events during the postoperative period in patients with oncoplastic, reconstructive and risk reduction surgery. Thus, in a comparative study between lumpectomy and oncoplastic surgery in patients in our unit, an incidence of skin necrosis of 2.5% was demonstrated in oncoplastic procedures compared to 0.1% in lumpectomy. This higher incidence of complications had a significant impact on the delay for the start of radiotherapy, increasing this delay by 10 days compared to the group with lumpectomy. In the context of mastectomy, our unit has recently published the results of its prospective study PreQ 20 and it has shown an incidence of 5.6% of necrosis and skin dehiscence in women with skin-sparing mastectomy and breast cancer. Finally, another prospective study identified technical complexity and the appearance of postoperative complications as the two variables related to the appearance of cosmetic sequelae during follow-up in patients in our unit. These results highlight the value of prevention and/or early identification of skin ischemia to reduce the rate of necrosis during the postoperative period, guarantee delays during the care process, reduce cosmetic sequelae, and increase satisfaction and quality of life for women. with breast cancer and/or at high risk.

Various studies have evaluated ICG angiography as a diagnostic method in mastectomy skin flap perfusion. To our knowledge, only two nonrandomized prospective studies have evaluated the sensitivity, specificity, and predictive values of this technique. The study by Phillips et al evaluated this procedure in 51 immediate reconstructions with expanders for the prediction of postoperative skin necrosis. Sensitivity, specificity, positive (PPV) and negative (NPV) predictive value were 90%, 50%, 56% and 88%, respectively. On the other hand, in the study by Munabi et al these values were 88%, 83%, 44% and 98%, respectively. In this latter study the authors found that smoking and epinephrine injection decreased the specificity of this diagnostic method from 98% to 83%. These studies have two limitations. The first refers to the fact that they have been performed in patients with a retropectoral breast reconstruction and through the use of expanders. Currently this type of reconstruction has been replaced by prepectoral reconstruction with direct implantation and for this reason we lack information on this new surgical modality. On the other hand, there are no studies that have evaluated ICG angiography in women with oncoplastic procedures.

A Cochrane Library review was recently published whose objective was to evaluate the capacity of ICG angiography for the prevention of necrosis in mastectomy skin flaps in women undergoing immediate reconstruction after skin-sparing mastectomy. In this review we found nine studies that compared the number of postoperative complications in women undergoing ICG breast skin assessment versus clinical assessment. In these studies, a total of 1,589 women with 2,199 breast reconstructions were evaluated, and the number of complications per patient or per breast was reported. The main patient-related results of this review were that:

* ICG can reduce reoperation rates.
* there is uncertainty as to whether ICG decreases the rates of mammary skin necrosis, infection, hematoma and seroma.

The main results referring to the breast were:

* ICG can reduce mammary skin necrosis, reoperation rates and infection.
* there is uncertainty as to whether ICG has an effect on hematoma and seroma rates. The evidence from the studies evaluated during this review is considered to be of very low quality as there are no prospective randomized studies. This review emphasizes the need for prospective studies to further investigate the use of the ICG in oncoplastic and reconstructive surgery of the breast.

These uncertainties have encouraged us to carry out this prospective study in order to evaluate the role of indocyanine green angiography in the intraoperative identification of skin areas at risk for the appearance of necrosis in the skin cover of the breast in women operated on by an immediate oncoplastic or reconstructive procedure. Usually, when we talk about a diagnostic procedure such as ICG angiography, its sensitivity, specificity, positive predictive value, and negative predictive value are described. These parameters reflect the characteristics of the diagnostic test and serve to decide when they should be used (sensitivity and specificity of the test) or what is the meaning of this test in a particular patient. Unfortunately, the scientific literature has not evaluated these parameters for ICG angiography in the context of prepectoral reconstruction and oncoplastic surgery, which leads to empirical use of this procedure. The ultimate goal of this study is to provide information on the sensitivity, specificity, and predictive values of ICG angiography in these two clinical settings. With this, we intend to identify those patients in whom this diagnostic procedure provides added value in their surgical planning, reducing the incidence of skin necrosis and other associated surgical complications.

Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery

Prospective Study for the Evaluation of the Efficacy and Concordance of Angiography With Indocyanine Green in the Identification of Complications After Oncoplastic Surgery and Skin and Nipple-skin Sparing Mastectomy

To assess the sensitivity, specificity, and predictive values of VIC angiography for intraoperative detection of skin areas at high risk for necrosis.

To evaluate the sensitivity, specificity, and predictive values of VIC angiography for the prediction of complications during the postoperative period (infection, seroma, hematoma, implant exposure, implant loss, reoperation).

To assess the presurgical ability of IVC angiography to identify dominant vascularity of the nipple-areola complex.

To assess the impact of IVC angiography on changing incision planning or surgical pattern.

Identify the time from injection to visualization on the SPY that best predicts necrosis.

University Hospital A Coruña

Breast Surgeon

Facies

Breast-conserving Surgery or modified radical mastectomy

Breast Surgery

Etienne El-Helou, MD

The aim of this observational study is to determine the factors influencing the decision-making process for breast surgery type, in Lebanese women likely to face breast cancer.

The main questions it aims to answer are the presence or not of a correlation between the type of choice and the following data:

* Demographic
* Health Status
* Several factors that may influence the decision

Participants will complete a well-structured and organized online survey

Factor Influencing Breast Surgery Type Decision-Making

Factors Influencing the Decision-making Process for Breast Surgery in Women Likely to Face Breast Cancer.

Factors influencing breast surgery type decision making process

Etienne El Helou

Principal Investigator

The intervention (post pilot study) is to systematically record the effect of routine use of acoustic as well as color imaging doppler during mammoplasty for breast cancer (for both the therapeutic and symmetrising breast reduction).

Use of Acoustic and color imaging doppler during surgery for breast cancer

Peter A Barry, MPhil, FRACS

Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result.

In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery.

We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery.

A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps).

We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply.

In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above.

Despite breast cancer being one of the most frequent affecting women worldwide, it is also one of the most curable. Its multimodality treatment is based on surgery, radiotherapy and systemic therapy.

Breast conservation has evolved thanks to the utilization of mammoplasty techniques to achieve better aesthetic results - known collectively as 'oncoplastic' when applied to cancer surgery.

The key considerations in oncoplastic surgery are: tumour characteristics (extent, location) and reconstituting the aesthetically acceptable breast shape as well as nipple-areola complex (NAC) preservation. The former is vital to achieve clear resection margins to optimise local control. Planning is aided by imaging with ultrasound, mammography and often MRI. NAC preservation is a priority and expectation of patients and surgeons alike developed in the field of aesthetic breast surgery by plastic surgeons.

The attachment of any structure to the body by its nourishing blood supply (arteries and veins) is known as a 'pedicle'. The anatomy of the pedicle and its preservation is key to preservation of the NAC which has a well understood blood supply albeit with variations across patients and well-described patterns (ref). To preserve the NAC as part of a cancer resection and aesthetic breast re-shaping, a pedicle must be fashioned and the NAC successfully re-positioned to restore the aesthetic balance of the newly shaped (and often lifted) breast.

The aim of this study is to determine if by use of doppler (acoustic or colour flow modalities) to map the blood vessels supplying the NAC (for each individual patient), surgeons and trainees can construct a safe pedicle with greater confidence and ease, reducing the concern about diminishing its blood supply which could lead to NAC necrosis and loss. We would like to study the nipple blood supply as it pertains to each patient before surgery using acoustic doppler (AD) and colour doppler imaging (CDI). Each modality has its strengths and weaknesses and this evaluation aims to assess the contribution of each.

The most challenging part of therapeutic mammoplasty is the pre-operative planning. The surgeon must consider (1) localization of the tumour location and extent, (2) re-shaping of the remaining breast parenchyma and (3) placement of the vascularized the NAC and pedicle.

Several studies have been done regarding NAC vascularization and its variation between not only each person, but also each side (right versus left). Most studies were on cadavers3, MRI 4or CT angiography5. On the other hand, Seitz et al6 pointed out the predominancy of the NAC vascularization based on preoperative MRI in the breast without cancer. Specifically, they split all 56 breasts into 5 categories: type I medial, type II lateral, type III central, type IV inferior, and type V mixed. Moreover, they highlighted that the majority of NACs were supplied mostly by medial vessels. Basaran et al7 evaluated sixteen patients with severe gigantomastia and they marked the vessel locations before surgery by using Doppler ultrasonography.

Given the variation between people and their breasts, in this SE we would like to map preoperatively the NAC vascularization to understand if it could assist the surgeon's plan or even enable them to modify the NAC pedicle design. The mapping will be done by both CDI and AC. We will use both techniques to understand if there will be any difference in their accuracy and to determine if 1 modality alone will suffice.

Whilst both methods (acoustic and colour flow doppler) are used selectively in cases by some surgeons, this SE will specifically if routine use incorporated into the procedure will systematically facilitate pedicle design. The doppler carries no risk to the patient and is considered a tool to facilitate surgery rather than an intervention beyond standard of care.

Specifically, acoustic doppler (AC) - is a hand-held device, easy to use intra-operatively which gives an audible signal in real-time to enable marking of the exact location of a blood vessel at a given point (or along a specified line) within the tissue / under the skin.

Colour doppler imaging (CDI) will additionally give visual information which includes the calibre and depth of the vessel and enables the entire course of the vessel and any connections to be mapped relatively easily.

In reality, when the design and shaping of the NAC pedicle is undertaken during the operation, ideal placement / movement of this structure may be restricted by the surrounding tissue attachments which the surgeon may be fearful of dividing in case a critical artery is divided in the process (compromising the NAC perfusion). Knowing the exact location of the artery will give the surgeon confidence in knowing how far such tissue mobilisation can be safely undertaken.

Some therapeutic mammoplasties also involve creation of a 'secondary pedicle' which consists of breast tissue - again mobilised on a pedicle which must be moved within the breast to fill a defect created by the cancer resection. A secondary aim of this SE will be to map the principle arteries which supply that tissue as well.

In summary, this SE aims to establish the benefits of an ad-hoc practice by careful documentation of consecutive cases prospectively during surgery for mammoplasty where NAC or secondary pedicle mobilisation is required.

Mapping Arterial Perforators Within the Breast During Mammoplasty

Mapping Arterial Perforators of the Nipple Areolar Complex and the Horizontal Septum During Mammoplasty

Any amount (as witnessed clinically) of full-thickness necrosis of the nipple-areolar complex of either breast in patients who have undergone breast reduction (for cancer - on the cancer side or matching reduction side)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction	NCT03012152	Breastcancer	Standard conser... Oncoplastic bre...	- 60 Years	Ain Shams University
Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer	NCT00820690	Breast Cancer	doxorubicin cyclophosphamid... paclitaxel Surgery	18 Years - 70 Years	Barretos Cancer Hospital
Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery	NCT05910931	Skin Necrosis Complication	ICG angiography	18 Years - 100 Years	University Hospital A Coruña
Factor Influencing Breast Surgery Type Decision-Making	NCT05604677	Breast Neoplasm	Breast Surgery	-	Dr Etienne El Helou
Mapping Arterial Perforators Within the Breast During Mammoplasty	NCT06347952	Breast Cancer	Use of Acoustic...	18 Years -	Royal Marsden NHS Foundation Trust
Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer	NCT00820690	Breast Cancer	doxorubicin cyclophosphamid... paclitaxel Surgery	18 Years - 70 Years	Barretos Cancer Hospital

Spots Global Cancer Trial Database for oncoplastic surgery