Single-port insufflation endoscopic nipple-sparing mastectomy in early breast cancer: a retrospective cohort study
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SUBMITTER: Liu W
PROVIDER: S-EPMC10660187 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
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Project description:IntroductionBreast cancer is the most prevalent cancer and the leading cause of cancer-related death in women. Conventional open mastectomy (C-OM) is one of the most common procedures for breast cancer, which involves the removal of the nipple-areola complex and a large proportion of the breast skin, leading to poor cosmetic effect and restriction of upper extremity function. Single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) could conceal the incision along the wrinkles in the axilla, preserve all the breast skin and nipple-areola complex and provide a better cosmetic outcome and quality of life. This trial aims to investigate the oncological safety between SIE-NSM and C-OM in early breast cancer patients.Methods and analysisThis is a single centre, non-blinded, randomised controlled trial (RCT) and will be conducted at Beijing Friendship Hospital. Patients will be enrolled in the inpatient ward. Breast surgeons will notify patients who meet the inclusion and exclusion criteria with the instruction of this RCT. Patients will be randomly assigned to C-OM or SIE-NSM with a 3:1 allocation as per a computer-generated randomisation schedule. Patients will be followed-up for 12 months for analysing surgical outcomes. The primary outcome is the local recurrence rate at a 12-month follow-up. The secondary outcome is the distant metastasis rate, cosmetic satisfaction score and psychosocial well-being score after a 12-month follow-up. To ensure the accuracy of the cosmetic satisfaction score and psychosocial well-being score, the standard scale, Breast-Q score, will be applied.Ethics and disseminationThis study will be conducted according to the medical ethics committee of the Beijing Friendship Hospital and according to the principles of the Declaration of Helsinki. All patients will receive clear instruction of their disease and treatment plan. Informed consent will be obtained from all patients when they agree to comply with our research plan. The results will be disseminated at academic presentations and publications in peer-reviewed journals. The raw data will be confidentially stored in our electronic data capture database. Data will not be shared unless an appropriate data request is submitted after the trial completion and peer-review journal publication.Trial registration numberNCT04461847.
| S-EPMC9062797 | biostudies-literature
Project description:IntroductionThis study compares the perioperative results, aesthetic outcome and oncologic safety of single-port insufflation endoscopic nipple-sparing subcutaneous mastectomy combined with immediate reconstruction using prosthesis implantation (SIE-NSM-IRPI) with those of conventional open-nipple and areola-sparing subcutaneous mastectomy combined with immediate reconstruction using prosthesis implantation (C-NSM-IRPI).MethodsIn this retrospective cohort study, 64 early-stage breast cancer patients were divided into SIE-NSM-IRPI (n = 38) and C-NSM-IRPI (n = 26) groups. Perioperative results (operation time, intraoperative blood loss, incision length, drainage duration, and recent complications) were then compared between the two groups. Differences in satisfaction with the breasts, psychosocial well-being, physical well-being (chest) and sexual well-being were analyzed according to the BREAST-Q scale, and survival outcomes were also compared.ResultsThe median follow-up time was 51.5 months. The incision length of SIE-NSM-IRPI was shorter than that of C-NSM-IRPI (P < 0.001). SIE-NSM-IRPI achieved the same detection rate and median number of sentinel lymph nodes as C-NSM-IRPI (3.00vs. 4.00, P = 0.780). The incidence of prosthesis removal due to infection or prosthesis exposure in the SIE-NSM-IRPI group was lower than that in the C-NSM-IRPI group (P = 0.015). Satisfaction with breasts (82.00vs.59.00, P < 0.001), psychosocial well-being (93.00vs.77.00, P = 0.001) and physical well-being (chest) (89.00vs.82.00, P < 0.001) scores were higher in the SIE-NSM-IRPI group. There were no significant differences between the two groups in disease-free survival (hazard ratio = 0.829, 95% confidence interval = 0.182-3.779) and overall survival (hazard ratio = 1.919, 95% confidence interval = 0.169-21.842).ConclusionIn this selected cohort of patients with early breast cancer, SIE-NSM-IRPI was comparable to C-NSM-IRPI, considering oncologic safety and detection of sentinel lymph nodes. It had a lower incidence of prosthesis removal, shorter incision length, and was associated with better patient satisfaction with the breasts. More random clinical trials of this novel approach in a larger cohort of Chinese patients with an extended follow-up period are needed in the future.
| S-EPMC10156621 | biostudies-literature
Project description:ImportanceRobotic-assisted nipple-sparing mastectomies with multiport robots have been described in the US since 2015; however, significant hurdles to multiport robotic surgery exist in breast surgery.ObjectiveTo demonstrate that the single-port da Vinci SP (Intuitive Surgical) robotic system is feasible in patients undergoing robotic nipple-sparing mastectomy (rNSM).Design, setting, and participantsAn initial case series of 20 patients at a large university hospital underwent bilateral single-port robotic nipple-sparing mastectomies (SPrNSM) with tissue expander reconstruction from February 1, 2020, through January 4, 2023. Participants included women who met surgical criteria for nipple-sparing mastectomies, per standard of care.InterventionSurgery using a single-port robot and the surgical technique of the authors.Main outcomes and measuresAge, indication, body mass index, breast size, operative time, conversion to open surgery, systemic complications, postoperative skin necrosis, and reported skin and nipple areolar complex (NAC) sensation.ResultsTwenty women aged 29 to 63 years (median, 40 years) underwent bilateral SPrNSM. Eleven patients completed prophylactic surgery due to a high risk for breast cancer (more than 20% lifetime risk) and 9 patients had breast cancer. Breast size ranged from A through D cup with median B cup and a body mass index range of 19.7 through 27.8 (median 24.4). The total duration of the procedure from incision to skin closure for both sides ranged from 205 minutes to 351 minutes (median, 277). The median robotic time for bilateral SPrNSM was 116 minutes and varied by cup size (A cup, 95 minutes; B cup, 140 minutes; C cup, 118 minutes; D cup, 114 minutes) with no inflection point in learning curve. No cases were converted to open and no immediate complications, such as hematoma, positive margins, or recurrence, were seen. In the first 10 patients prior to routine sensation testing, 20 resected breasts had measurable NAC sensation at a range from 4 to 36 months post-index resection (65%). In the second 10 patients of the cohort, measurable NAC was preserved in 13 of 20 resected breasts 2 weeks following the index operation (65%).Conclusion and relevanceIn this case series, SPrNSM with immediate reconstruction was feasible and performed safely by an experienced breast surgeon with limited previous robotic training. Further studies confirming the preliminary data demonstrating improved NAC and skin sensation following SPrNSM are warranted.Trial registrationClinicalTrials.gov Identifier: NCT05245812.
| S-EPMC10794977 | biostudies-literature
Project description:BackgroundThe current surgical methods for managing incisions after nipple excision in breast reconstruction patients are limited. However, double purse-string suture (DPS) shows promise in the treatment of nipple excision. This study aimed to investigate the safety and aesthetic outcomes of DPS nipple reconstruction in early breast cancer patients who underwent endoscopic skin-sparing mastectomy (E-SSM) and breast reconstruction.MethodsWe retrospectively analyzed the clinical data of 87 early breast cancer patients with nipple excision who underwent E-SSM with breast reconstruction. According to the suture methods of nipple incision, all patients were divided into the spindle suture (SS) group, single purse-string suture (SPS) group, and DPS group, with SS and SPS groups combined as the traditional suture (TS) group. Then, we compared the groups' differences in aesthetic outcomes, surgical safety, and oncological safety.ResultsA total of 87 patients with 88 breasts were enrolled in this study (SS n=17, SPS n=21, DPS n=50). Patients in the DPS group had significantly better nipple reconstruction satisfaction, Harris scale and any complications incidence than the TS group (all p <0.05). For nipple reconstruction satisfaction and any complication, the adjusted OR (95%CI) of the DPS group were 6.314(1.095-36.415) (p=0.039) and 0.124(0.018-0.863) (p=0.035) compared with the SS group. One patient in the SS group had vertebral metastases, and no recurrence, metastasis, or death has been observed in the other two groups during the follow-up period.ConclusionsDPS is an effective and safe nipple reconstruction procedure for patients undergoing E-SSM with breast reconstruction, delivering excellent aesthetic outcomes.
| S-EPMC11476627 | biostudies-literature
Project description:PurposeIndications for nipple-sparing mastectomy (NSM) have broadened to include the risk reducing setting and locally advanced tumors, which resulted in a dramatic increase in the use of NSM. The Oncoplastic Breast Consortium consensus conference on NSM and immediate reconstruction was held to address a variety of questions in clinical practice and research based on published evidence and expert panel opinion.MethodsThe panel consisted of 44 breast surgeons from 14 countries across four continents with a background in gynecology, general or reconstructive surgery and a practice dedicated to breast cancer, as well as a patient advocate. Panelists presented evidence summaries relating to each topic for debate during the in-person consensus conference. The iterative process in question development, voting, and wording of the recommendations followed the modified Delphi methodology.ResultsConsensus recommendations were reached in 35, majority recommendations in 24, and no recommendations in the remaining 12 questions. The panel acknowledged the need for standardization of various aspects of NSM and immediate reconstruction. It endorsed several oncological contraindications to the preservation of the skin and nipple. Furthermore, it recommended inclusion of patients in prospective registries and routine assessment of patient-reported outcomes. Considerable heterogeneity in breast reconstruction practice became obvious during the conference.ConclusionsIn case of conflicting or missing evidence to guide treatment, the consensus conference revealed substantial disagreement in expert panel opinion, which, among others, supports the need for a randomized trial to evaluate the safest and most efficacious reconstruction techniques.
| S-EPMC6245050 | biostudies-literature
Project description:IntroductionWhile the long-term oncologic safety of robot-assisted nipple sparing mastectomy (RNSM) remains to be elucidated, histologically detected residual breast tissue (RBT) can be a surrogate for oncologically sound mastectomy. The objective of this study is to determine the presence of RBT after RNSM.MethodsBetween August 2019-January 2020, we completed 5 cadaveric RNSMs. Full thickness biopsies from the mastectomy skin flap were obtained from predefined locations radially around the mastectomy skin envelop and nipple areolar complex to histologically evaluate for RBT.ResultsThe first case was not technically feasible due to inability to obtain adequate insufflation. Five mastectomy flaps were analyzable. The average mastectomy flap thickness was 2.3 mm (range 2-3 mm) and the average specimen weight was 382.72 g (range 146.9-558.3 g). Of 70 total biopsies, RBT was detected in 11 (15.7%) biopsies. Most common location for RBT was in the nipple-areolar complex, with no RBT detected from the peripheral skin flaps.ConclusionsIn this cadaveric study, RNSM is feasible leaving minimal RBT on the mastectomy flap. The most common location for RBT is in the periareolar location consistent with previous published findings after open NSM. Clinical studies are underway to evaluate the safety of RNSM.
| S-EPMC7726449 | biostudies-literature
Project description:BackgroundSeveral studies reported the feasibility and safety of robotic-NSM (R-NSM). The aim of our prospective study was to compare R-NSM and conventional-NSM (C-NSM).MethodsWe analyzed patients who were operated on with and without robotic assistance (R-NSM or C-NSM) and who received immediate breast reconstruction (IBR) with implant or latissimus dorsi-flap (LDF). The main objective was complication rate and secondary aims were post-operative length of hospitalization (POLH), duration of surgery, and cost.ResultsWe analyzed 87 R-NSM and 142 C-NSM with implant-IBR in 50 and 135 patients, with LDF-IBR in 37 and 7 patients, respectively. Higher durations of surgery and costs were observed for R-NSM, without a difference in POLH and interval time to adjuvant therapy between R-NSM and C-NSM. In the multivariate analysis, R-NSM was not associated with a higher breast complication rate (OR=0.608) and significant factors were breast cup-size, LDF combined with implant-IBR, tobacco and inversed-T incision. Grade 2-3 breast complications rate were 13% for R-NSM and 17.3% for C-NSM, significantly higher for LDF combined with implant-IBR, areolar/radial incisions and BMI>=30. A predictive score was calculated (AUC=0.754). In logistic regression, patient's satisfaction between C-NSM and R-NSM were not significantly different, with unfavorable results for BMI >=25 (OR=2.139), NSM for recurrence (OR=5.371) and primary breast cancer with radiotherapy (OR=4.533). A predictive score was calculated. In conclusion, our study confirms the comparable clinical outcome between C- NSM and R-NSM, in the price of longer surgery and higher cost for R-NSM. Predictive scores of breast complications and satisfaction were significantly associated with factors known in the pre-operative period.
| S-EPMC7971115 | biostudies-literature
Project description:ObjectivesCompared with nipple sparing mastectomy (NSM), microwave ablation (MWA) is one relatively new modality indicated for selected breast cancer with nipple sparing and with little of evidence-based medical research for decision-making. The objective of this study was to compare the effect of ultrasound-guided percutaneous MWA and NSM for breast cancer.Materials and methodsA retrospective cohort study was conducted in a single institution from 2014 to 2020. Women with invasive ductal carcinoma of the breast ≤ 5cm treated by MWA or NSM were enrolled. The primary end point was tumor progression and secondary end points included survival, cosmetic results, and complications.Results21 patients in the MWA group and 43 in the NSM group were evaluated. The mean tumor size was 2.3 cm (range, 0.3-5.0 cm). Median follow-up was 26.7 months (range, 14.6-62.5 months). The mean age of MWA was 24 years older than that of the NSM group. All the patients achieved technique effectiveness. One local tumor progression and one ipsilateral breast recurrence occurred at 42 and 28 months after MWA, respectively. One ipsilateral breast recurrence and two bone metastasis occurred at 31.2, 34, and 30.5 months after NSM. Two groups had no significant difference in tumor progression (P = 0.16). No participants in both groups developed cancer related death (P > 0.99) and major complications (P > 0.99). However, MWA needed less hospitalization time (P < 0.001) and achieved better cosmetic results (P < 0.001).ConclusionsMWA achieved similar short term effect for breast cancer control and better cosmetic satisfaction compared with NSM in selected patients. MWA provides appropriate option for elderly patients who are unfit for surgery.
| S-EPMC7576845 | biostudies-literature
Project description:Breast cancer is worldwide the most common cause of cancer in women and causes the second most common cancer-related death. Nipple-sparing mastectomy (NSM) is commonly used in therapeutic and prophylactic settings. Furthermore, (preventive) mastectomies are, besides complications, also associated with psychological and cosmetic consequences. Robotic NSM (RNSM) allows for better visualization of the planes and reducing the invasiveness. The aim of this study was to compare the postoperative complication rate of RNSM to NSM. A systematic search was performed on all (R)NSM articles. The primary outcome was determining the overall postoperative complication rate of traditional NSM and RNSM. Secondary outcomes were comparing the specific postoperative complication rates: implant loss, hematoma, (flap)necrosis, infection, and seroma. Forty-nine studies containing 13,886 cases of (R)NSM were included. No statistically significant differences were found regarding postoperative complications (RNSM 3.9%, NSM 7.0%, p = 0.070), postoperative implant loss (RNSM 4.1%, NSM 3.2%, p = 0.523), hematomas (RNSM 4.3%, NSM 2.0%, p = 0.059), necrosis (RNSM 4.3%, NSM 7.4%, p = 0.230), infection (RNSM 8.3%, NSM 4.0%, p = 0.054) or seromas (RNSM 3.0%, NSM 2.0%, p = 0.421). Overall, there are no statistically significant differences in complication rates between NSM and RNSM.
| S-EPMC8960562 | biostudies-literature
Project description:BackgroundOur center proposes a new technique that effectively provides space to broaden the surgical field of view and overcomes the limitations of endoscopy-assisted nipple-sparing mastectomy (E-NSM) by changing the dissection sequence and combining it with air inflation. The purpose of this study was to compare the clinical outcomes of the new technique designated "reverse-sequence endoscopic nipple-sparing mastectomy (R-E-NSM) with subpectoral breast reconstruction (SBR)" and the conventional E-NSM (C-E-NSM) with SBR.MethodAll patients undergoing E-NSM with SBR at our breast center between April 2017 and December 2022 were included in this study. The cohort was divided into the C-E-NSM group and the R-E-NSM group. The operation time, anesthesia time, medical cost, complications, cosmetic outcomes, and oncological safety were compared.ResultsTwenty-six and seventy-nine consecutive patients were included in the C-E-NSM and R-E-NSM groups, with average ages of 36.9 ± 7.0 years and 39.7 ± 8.4 years (P=0.128). Patients in the R-E-NSM group had significantly shorter operation time (204.6 ± 59.2 vs. 318.9 ± 75.5 minutes, p<0.001) and anesthesia time (279.4 ± 83.9 vs. 408.9 ± 87.4 minutes, p<0.001) and decreased medical costs [5063.4 (4439.6-6532.3) vs. 6404.2 (5152.5-7981.5), USD, p=0.001] and increase SCAR-Q scores (77.2 ± 17.1 vs. 68.8 ± 8.7, P=0.002) compared to the C-E-NSM group. Although trends increased in both the excellent rate of Ueda scores (53.8% vs. 42.3%, P = 0.144), excellent rate of Harris scores (44.0% vs. 63.1%, P=0.102), and decreased surgical complications (7.6% vs. 19.2%, P = 0.135) were observed in the R-E-NSM group, the differences were not significant. There were no significant differences in oncological outcomes between the two groups.ConclusionR-E-NSM improves cosmetic outcomes and efficiency of C-E-NSM, reduces medical costs, and has a trend of lower surgical complications while maintaining the safety of oncology. It is a safe and feasible option for oncological procedures that deserves to be promoted and widely adopted in practice.
| S-EPMC10951398 | biostudies-literature