Clinical Research On Endoscopic Modified Radical Mastectomy And Pedicled Omentum For Immediate Breast Reconstruction By Digital 3D Technique

BackgroundBecause the improvement of the life quality without compromising the long-term survival rate, not only breast-conserving surgery has become the main surgical procedure for early breast cancer in developed countries, but also the utility ratio of the breast-conserving therapy has been regarded as an important symbol of treatment for breast cancer. The combination of endoscopic techniques and breast conserving-reconstruction surgery only left a few small scars in the lateral chest wall and areola, reshaping the female body in the guarantee of radical therapy, reducing the psychological hurt, letting patients quickly return to society and rebuilding confidence. So this combination is widely welcomed by both doctors and patients.Therefore, in order to apply the endoscopic technique in breast-conserving and pedicled omentum for immediate breast reconstruction, preoperative evaluation is a critical aspect. There are several aspects that surgeons must understand preoperatively: 1. Axillary lymph node status:Surgeons should select the sentinel lymph node biopsy or axillary lymph node dissection; 2. Whether breast-conserving and adequate negative margin is ensured or not; 3. The size, location and blood supply of breastcancer must be clear, in addition, the relationship among the tumor, nipple, pectoralis major and skin should be understood; 4. Calculating the volume of filling tissue after mammary excision, in order to design breast reconstruction. Current conventional inspection methods such as ultrasound, breast mammography, CT, MR and others can not meet the need of the evaluation preoperatively and postoperatively. It is necessary to find a new technology to assist minimally invasive surgical treatment for breast cancer.In this study, based on 256-slice spiral CT data, we used the digital 3D technique to study the digital anatomy models preoperatively and design the surgery, investigate the value of digital 3D technique on diagnosis of breast cancer and axillary lymph nodes metastasis, endoscopic sentinel lymph node biopsy, endoscopic axillary lymphadenectomy combined with pedicled omentum for breast reconstruction.Part 1 Application research on digital 3D technique in the diagnosis of breast tumor and axillary lymph node metastasisObjectiveStudy the application of digital 3D technique based on 256-slice spiral CT data in the diagnosis of breast tumor and axillary lymph node metastasis.Methods1. ExaminersThe 80 patients with breast disease in our hospital from December 2012 to June 2014 were recruited. Their mammography or ultrasound results revealed grade IV and above. They underwent 256-CTA for acquisition of their CT data. Their ages range from 28 to 72, with an average age of 49.3.2. Materials(1) 256-slice spiral CT, double-tube high pressure syringe and the contrast agent;(2) CT post-processing workstation for PHILIPS 256-slice spiral CT;(3) Dedicated computer in Digital Clinical Research Center, Southern Medical University;(4) Xudong digital medical image processing software;(5) Medical Image Visualization System (self-developed);(6) FreeForm Modeling System and the digital 3D PHANTOM operating equipment;3. Scanning parameters and data collectionIn accordance with the standard scanning parameters of 256-slice spiral CTA, CTA scanning adopted the group note tracking method. After the scan was completed, the image data was sent to Mxview workstation, and then the data was transmitted through internal network lines and was stored by server in Digital Clinical Research Center, Southern Medical University.4. Image segmentation and digital 3D reconstructionWe performed automatic digital 3D reconstruction on CTA data in mammary artery, tumor artery, axillary vessel, lymph nodes and other targeted organs of 80 cases with suspected breast tumor. Then the individual 3D model was exported as STL format. Finally we assessed the diagnosis of breast tumor and axillary lymph node metastasis by Xudong medical CT image post-processing software and FreeForm Modeling System, comparing the diagnostic value among digital 3D technology, Bultrasound, mammography in breast tumor and axillary lymph node metastasis, calculating the consistent rate, sensitivity, specificity, positive predictive value and negative predictive value. All statistical analysis was performed by SPSS 20.0.Results1. The distribution feature of 80 cases with breast tumorTheir ages range from 28 to 72, with an average age of 49.3. The primary tumor diameter was 0.9～5.1cm, with an average of 2.3cm; Among malignant tumors,2 cases was in clinical stage 0,21 cases was in clinical stage I,36 cases in clinical Ⅱ; The distribution of pathological type are 19 cases of fibroadenoma,1 cases of breast adenosis,55 cases of invasive ductal carcinoma,2 cases of ductal carcinoma in situ,1 cases of pleomorphic carcinoma and 1 cases of invasive lobular carcinoma.2. The acquisition results of 256-slice spiral CT dataTotal acquisition of 80 sets of of DICOM image was collected from three CT periods-scan phase (about 110 sheets), arterial phase (about 600 sheets) and venous phase (about 600 sheets). The image quality was high enough to clearly show the location shape, edge, calcifications of breast tumor and the relationship with the skin, nipple, pectoralis major.3. The results of digital 3D reconstruction for breast and armpitThe models were clear and vivid, rotating multidirectional freely, visualizing the relationship among the breast, tumors, skin, nipple and pectoralis major intuitively, revealing the mutual relationship between axillary lymph nodes and axillary vessels clearly. The statistics were carried on to the characteristics of the breast tumor and axillary lymph node in 80 cases.4. The diagnostic comparison among digital 3D technique, ultrasound, mammography in breast cancerIn three methods of ultrasound, mammography and digital 3D technique, the authenticity and reliability of results for digital 3D technique was high; and using digital 3D technique to estimate the possibilities of suffering benign or malignant tumor is best among the 3 methods.5. The diagnostic comparison between digital 3D technique and ultrasound in axillary lymph nodes metastasisUsing pathological diagnosis as the gold standard, the coincidence rate, sensitivity, specificity and Youden’s index of digital 3D technique were greater than ultrasound. Therefore, the results of digital 3D technique had the highest validity and credibility, namely, the accuracy, reliability of digital 3D technique were much higher than ultrasound.ConclusionsBase on high authenticity, reliability and predictability of digital 3D technique in diagnosis of breast tumor and axillary lymph node metastasis, digital 3D technique have a significant clinical application value.Part 2 The application of the digital 3D technique in endoscopic axillary sentinel lymph node biopsy and axillary lymph node dissectionObjectiveTo study the clinical value of endoscopic axillary sentinel lymph node biopsy and axillary lymph node dissection in breast cancer using digital 3D technique.Methods1. Examiners:28 patients with breast cancer by biopsy in our hospital or other hospitals were recruited from December 2012 to June 2014. Their age ranges from 33 to 68, with an average of 45.8. They performed CT lymphography before 256 layers of CTA scans to collect the SLN data;2. Data acquisition equipment and scan parameters were the same as Part 1;3. Data Collection MethodsWe firstly used 1% lidocaine lml to perform local anesthesia and injected ioversol at 3,6,9 and 12 o’clock direction of areola, then the patients underwent 256-slice CT scan after 3 min to acquire the enhanced SLN data;4. Image segmentation and 3D reconstruction was the same as Part 1;5. The creation of the endoscopic surgical instruments for breast cancerWe used VTK software and FreeForm Modeling System to create various types of surgical instruments such as scalpels, ultrasonic scalpel, forceps, long needles, syringes liposuction rods and drainage tubes, etc.6. The localization of sentinel lymph node and the construction of visual surgery platform(1) The localization of sentinel lymph node and its judgment of benign or malignant:From the injection site along the enhancement of lymphatic vessels into the lymph nodes, the first enhanced lymph node was judged as sentinel lymph node. The significantly uniform enhanced lymph nodes were determined as benign, and the perfusion defects were determined as metastatic through observation of lymph nodes angiography. The result of lymphography was analyzed by a clinical surgeon and a radiologist.(2) The establishment of visual surgery platform and procedures of visual endoscopic axillary sentinel lymph node biopsy and lymph node dissectionIn surgical visualization system, we perform the surgery step by step:① Imported 3D models which were consistent with patients in order to locate the sentinel lymph nodes precisely; ②Pre-designed the position of endoscopic incision; ③ Placed the long needle from endoscopic incision to the sentinel lymph node position, then injected fat soluble liquid to dissolve the fat;④Pre-designed the placement position, orientation, fat dissolving area of needle to determine the adequacy of the fat dissolving scope, to know the relationship between the axillary vein and axillary lymph nodes; ⑤ Placed 3D endoscopic instruments to perform axillary sentinel lymph node biopsy and endoscopic axillary lymph node dissection.(3) In clinical surgery, according to CT lymphography and the visual simulation surgery, we performed the endoscopic sentinel lymph node biopsy and axillary lymph node dissection. We calculated the accuracy, sensitivity, specificity of the sentinel lymph nodes, and then evaluated the application value of CT lymphography positioning technique in the axillary sentinel lymph node biopsy.Results1. The results of individual 3D models and visualization of surgical instrumentsThe axillary 3D models in 28 cases were in full compliance with the patients. The anatomy signs were correct and it can clearly display the mutual relationship among sentinel lymph node, axillary lymph node, axillary vein, pectoralis major, pectoralis minor muscle and latissimus dorsi, etc.The shape and size of various types of surgical tools were fully consistent with the real ones, and were operated flexibility to meet the needs of visual simulation surgery.2. The result of the visual simulation surgery in endoscopic axillary sentinel lymph node biopsy and endoscopic axillary lymph node dissectionDigital 3D model of 28 patients were imported into FreeForm Modeling Surgical System platform for visual simulation surgery in endoscopic axillary sentinel lymph node biopsy and endoscopic axillary lymph node dissection. The actual clinical surgery was fully in accordance with the visual simulation surgical procedures, and we located the sentinel lymph node quickly. The coincidence rate of sentinel lymph node biopsy in the patients was 96.43%(27/28), sensitivity was 92.31%(12/13), the false negative rate 7.69%(1/13). Complications such as affected limb pain, swelling, wound infection, subcutaneous hydrops and others were not found in the postoperative follow-up of 28 patients.Conclusions1. Digital 3D technique combined with methylene blue in endoscopic sentinel lymph node biopsy can reflect the axillary condition of the patients with breast cancer accurately, and it can be used as a new method for sentinel lymph node biopsy;2. Visual simulation surgery of axillary lymph node dissection is helpful for preoperative planning, shortening the operative time, reducing complications and enhancing the communication between doctors and patients.Part 3 Clinical research on breast volume calculations and harvested pedicled omentum for immediate breast cancer construction surgery using digital 3D techniqueObjectiveTo investigate the application of digital 3D technique in breast volume calculations and pedicled omentum for immediate breast reconstruction.Methods1. Examiners:18 of the 28 breast cancer patients selected in Part 2 met the inclusion criteria of pedicled omentum for immediate breast reconstruction.2. Data acquisition devices, scanning parameters and digital 3D reconstruction were the same as the Part 1.3. Segmentation and calculation of breast volumeWe imported the CT data of 18 patients to our self-developed 3D medical image visualization system to segment and reconstruct the breast, then calculated the breast volume, predetermined the removal range of the breast volume and performed the visual simulation surgery. If the predetermined removal of the gland volume was greater than 1/2 breast volume, it was recommended to choose other breast reconstruction surgery.4. Preoperative evaluation and clinical surgery of pedicled omentum for immediate breast reconstructionAccording to the preoperative evaluation results of 3D models, we marked tumor location, breast contour, gland excision scope and breast folds on the skin of patients. We conducted the clinical surgery based on the result of the visual simulation surgery and evaluated the application of digital 3D technique for immediate breast reconstruction surgery.5. The postoperative adjuvant therapy and the evaluation of breast aestheticsAll patients were treated with systemic therapy and radiation therapy according to standard institutional protocols (NCCN). In addition, the patients with Her-2 (+++) were treated with Herceptin. No case of cancer recurrence was found during the follow-up, which lasted for 6-24 months after the operation. Cosmetic outcomes were evaluated 6 months after the surgery, according to the Harris criteria.Results1. The volume calculation results of breast, tumor and the predetermined removal of the breast in 18 patientsWe calculated volume of breast, tumor and the predetermined removal of the breast to ensure the distance from surgical margin to the tumor was greater than 2cm. As the tumor size is too large,2 patients needed to excise the gland volume more than 1/2 of the breast volume, and finally 1 patient underwent pedicled omentum combined with latissimus dorsi flap for construction, the other patient underwent total mastectomy. The rest 16 patients accorded with the indications of omentum reconstructive surgery and successfully received clinical surgery.2. Evaluation on omentum breast reconstruction by digital 3D techniqueThe cosmetic results were mostly satisfactory at 6 months after the surgery. The scars on the breast, chest wall, and abdomen were not obvious. No deformity was found in the axilla in any patient. All patients were satisfied with the reconstructed breast. No size reduction of the reconstructed breast was found after radiation therapy. Conclusions1. Endoscopic pedicled omentum for immediate breast reconstruction surgery is a viable, safe procedure that causes minimal surgical trauma and results in a soft, shapely breast postoperatively.2. As the breast volume can be calculated accurately by digital 3D technique, we can use it to predetermine the removal range of the breast, measure the distance from tumor to surgical margin exactly preoperatively. Therefore, the digital 3D technique was a important method to assist endoscopic pedicled omentum for immediate breast reconstruction surgery.