Defining the learning curve for successful staging with sentinel lymph node biopsy for endometrial cancer among surgeons at an academic institution.

BACKGROUND: Sentinel lymph node (SLN) biopsy is increasingly used in endometrial cancer staging; however, success of the technique is variable, and the learning curve needs to be better understood. Success is defined as identification of a SLN specimen containing nodal tissue in bilateral hemi-pelvises. OBJECTIVE: To assess the learning curve of surgeons at an academic institution in performing successful SLN mapping and biopsy during robotic staging for endometrial cancer. METHODS: After institutional review board approval, patients who underwent staging with robotic SLN mapping using indocyanine green at a single academic program between July 2012 and December 2017 were identified. Demographic, pathologic, and surgical data were retrospectively collected from the medical records. Descriptive and comparative statistics were performed. Surgeon rates of successful bilateral SLN mapping and removal of lymphoid-containing SLN specimens were compared. A logistic model was used to analyze the probability of successful SLN mapping and removal of lymph node-containing tissue with increasing number of procedures performed. RESULTS: Three hundred and seventeen patients met the eligibility criteria. Most had early-stage, low-grade endometrial cancer. A total of 194 (61%) patients had successful bilateral mapping. Among seven surgeons, a plateau in rates of successful bilateral mapping was achieved after 40 cases. No linear correlation was seen between the number of surgeries performed and the rate of removal of lymph node-containing tissue among surgeons. Each additional 10 procedures performed was associated with a 5% and an 11% increase in the odds of successful SLN mapping and removal of lymph node-containing tissue, respectively. DISCUSSION: The successful removal of lymph node-containing specimens appears to be a surgeon-specific phenomenon. The plateau of the learning curve for successful bilateral mapping seems to be reached at around 40 cases. These first 40 cases offer a time for auditing of individual rates of SLN mapping and removal to identify surgeons who may benefit from procedure-specific remediation.

Fifteen-Year Decrease in General Surgery Resident Breast Operative Experience: Are We Training Proficient Breast Surgeons?

OBJECTIVE: The goal of the study was to evaluate trends in general surgery resident breast cases over the past 15 years. STUDY DESIGN: The Accreditation Council for Graduate Medical Education (ACGME) Case Logs Statistics Reports from 2000 to 2015 were reviewed for average breast-specific case numbers and trends over time. ACGME data were available for all cases and breast-specific cases including the following: excisional biopsy/lumpectomy, simple mastectomy, modified radical mastectomy, and sentinel lymph node excision. SETTING: The study evaluation was conducted at Cleveland Clinic, Cleveland, Ohio. PARTICIPANTS: No individuals directly participated in this project. However, all general surgery residents at ACGME-accredited programs are represented in this analysis by virtue of the ACGME Case Logs Statistics Reports. RESULTS: Total residency case volume increased by 2% (2000-2015, p = 0.0159), with 2015 graduates logging 985.5 cases. In contrast, breast cases decreased by 17.1%. The largest drops were in modified radical mastectomy (61.5% decrease, p = 0.0001) and excisional biopsy/lumpectomy (25.8% decrease). Simple mastectomy increased from 6.0 to 10.8 cases (p = 0.0001). Sentinel lymph node excision fluctuated, but has been down-trending recently (67.3% decrease from 2010 to 2015, p = 0.0001). Decreased experience is occurring at both junior and senior resident levels. CONCLUSIONS: Breast case operative experience for general surgery residents decreased by 17% between 2000 and 2015, despite increase in overall operative volume. Residents have less experience in more advanced cases including axillary management, raising concern about the proficiency of graduating surgeons with respect to these procedures. It is reasonable to set national minimums for resident breast operative experience to ensure that individuals are appropriately trained to perform these cases in practice.

Melanoma, version 2.2013: featured updates to the NCCN guidelines.

The NCCN Guidelines for Melanoma provide multidisciplinary recommendations on the clinical management of patients with melanoma. This NCCN Guidelines Insights report highlights notable recent updates. Foremost of these is the exciting addition of the novel agents ipilimumab and vemurafenib for treatment of advanced melanoma. The NCCN panel also included imatinib as a treatment for KIT-mutated tumors and pegylated interferon alfa-2b as an option for adjuvant therapy. Also important are revisions to the initial stratification of early-stage lesions based on the risk of sentinel lymph node metastases, and revised recommendations on the use of sentinel lymph node biopsy for low-risk groups. Finally, the NCCN panel reached clinical consensus on clarifying the role of imaging in the workup of patients with melanoma.

Results of a national training programme in sentinel lymph node biopsy for breast cancer.

BACKGROUND: New Start, a structured, validated, multidisciplinary training programme in sentinel lymph node biopsy (SLNB), was established to allow the introduction and rapid transfer of appropriate knowledge and technical skills to ensure safe and competent practice across the UK. METHODS: Multidisciplinary teams attended a theory/skills laboratory course, following which they performed 30 consecutive SLNBs, either concurrently with their standard axillary staging procedure (training model A) or as stand-alone SLNB (training model B). SLNB was performed according to a standard protocol using the combined technique of isotope ((99m) Tc-labelled albumin colloid) and blue dye. An accredited New Start trainer mentored the first five procedures in the participant's hospital, or all 30 if stand-alone. Validation standards for model A and B were a localization rate of at least 90 per cent. In addition, for model A only, in which a minimum of ten patients were required to be node-positive, a false-negative rate (FNR) of 10 per cent or less was required. RESULTS: From October 2004 to December 2008, 210 SLNB-naive surgeons, in 103 centres, performed 6685 SLNB procedures. The overall sentinel lymph node (SLN) localization rate was 98·9 (95 per cent confidence interval 98·6 to 99·1) per cent (6610 of 6685) and the FNR 9·1 (7·9 to 10·5) per cent (160 of 1757). The FNR was related to nodal yield, ranging from 14·8 per cent for one node and declining to 9·7, 6·6, 4·7 and 4·1 per cent for two, three, four and more than four SLNs respectively. No learning curve was identified for localization or FNR. CONCLUSION: The programme successfully trained a wide range of UK breast teams to perform safe SLNB and suggested that a standard injection protocol and structured multidisciplinary training can abolish learning curves.

Animal model for training in sentinel lymph node biopsy of the stomach through combined methods.

PURPOSE: Create and validate a proposed animal model for training in sentinel lymph node biopsy of the stomach. METHODS: In thirty-two rabbits, through a laparotomy, they received a subserosal injection of 0.1 ml of phytate labeled with technetium-99m (0.2 mCi) in the anterior wall of the gastric corpus, followed by 0.2 ml of Blue Patent V(®) 2.5%, through the same puncture site. Suspicious lymph nodes were searched in vivo at five, ten and 20 minutes, both visually (Blue Patent stained lymph nodes) and with a manual gamma radiation detector (to detect suspected radioactive lymph nodes). After 20 minutes, was performed resection of these for further evaluation of radioactivity (ex vivo) and histological study. RESULTS: Lymph nodes were identified in 30 rabbits (Average of 2.2 lymph nodes per animal). Of the 90 suspected lymph nodes that occurred in the study, 70 cases (77.8%) were histologically confirmed for lymphoid tissue. Of these, the majority were located in the periesophageal region of the gastric fundus. The sample presented a mortality rate of 6.25% and nine complications related to the method, which interfered in the identification of the lymph nodes. CONCLUSION: The animal model for sentinel node biopsy in rabbit stomachs proved to be feasible, with low complexity and reproduced the difficulties encountered for gastric lymph node biopsy in humans, being adequate for surgical training.

Animal model for training in sentinel lymph node biopsy of the stomach through combined methods / Modelo animal para treinamento em pesquisa de linfonodo sentinela em estômago mediante métodos combinados

PURPOSE: Create and validate a proposed animal model for training in sentinel lymph node biopsy of the stomach. METHODS: In thirty-two rabbits, through a laparotomy, they received a subserosal injection of 0.1 ml of phytate labeled with technetium-99m (0.2 mCi) in the anterior wall of the gastric corpus, followed by 0.2 ml of Blue Patent V® 2.5%, through the same puncture site. Suspicious lymph nodes were searched in vivo at five, ten and 20 minutes, both visually (Blue Patent stained lymph nodes) and with a manual gamma radiation detector (to detect suspected radioactive lymph nodes). After 20 minutes, was performed resection of these for further evaluation of radioactivity (ex vivo) and histological study. RESULTS: Lymph nodes were identified in 30 rabbits (Average of 2.2 lymph nodes per animal). Of the 90 suspected lymph nodes that occurred in the study, 70 cases (77.8%) were histologically confirmed for lymphoid tissue. Of these, the majority were located in the periesophageal region of the gastric fundus. The sample presented a mortality rate of 6.25% and nine complications related to the method, which interfered in the identification of the lymph nodes. CONCLUSION: The animal model for sentinel node biopsy in rabbit stomachs proved to be feasible, with low complexity and reproduced the difficulties encountered for gastric lymph node biopsy in humans, being adequate for surgical training.

OBJETIVO: Criar e validar uma proposta de modelo animal para o treinamento em pesquisa de linfonodos sentinelas no estômago. MÉTODOS: Em trinta e dois coelhos, mediante laparotomia, foi injetado na subserosa da parede anterior do corpo gástrico, 0,1 ml de fitato marcado com tecnécio-99m (0,2 mCi), seguido pelo mesmo orifício, de 0,2 ml de Azul Patente V® 2,5%. A cavidade abdominal foi avaliada, in vivo, por meio de inspeção para pesquisa de suspeitas de linfonodos azuis e com detector manual de radiação gamma aos cinco, dez e 20 minutos para pesquisa de suspeitas de linfonodos radioativas. Após 20 minutos, foi realizada a ressecção dessas para posterior avaliação da radioactividade (ex vivo) e estudo histológico. RESULTADOS: Foram identificados linfonodos em 30 coelhos (Média de 2,2 linfonodos por animal). Das 90 suspeitas de linfonodos ocorridas no estudo, em 70 casos (77,8%) obteve-se confirmação histológica para tecido linfóide. Destas, a maioria estava localizada na região periesofágica do fundo gástrico. A amostra apresentou taxa de mortalidade de 6,25% e nove intercorrências relacionadas ao método, que interferiram na identificação dos linfonodos. CONCLUSÃO: O modelo animal para pesquisa de linfonodos sentinelas em estômago de coelhos mostrou-se factível, pouco complexo e reproduziu as dificuldades encontradas para a pesquisa de linfonodos gástricos em humanos, sendo adequado para o treinamento cirúrgico.

Evaluation of a trainer phantom in the learning phase of sentinel lymph node identification in breast cancer.

BACKGROUND: The concept of a learning phase is difficult to implement in a university setting, as it is unacceptable to subject a patient who requires only lymphadenectomy to axillary dissection for the purpose of training surgeons. We therefore sought to evaluate intraoperative sentinel node detection using a phantom, the Senti-Trainer. Learning phases on the Senti-Trainer and detection rate were assessed in order to determine whether the proficiency of surgeons in training improved with the number of procedures. METHODS: Twenty residents each performed 30 detection procedures of a sentinel node on the silicon phantom. Each resident was evaluated at each procedure, and an observation report was made every five procedures. Evaluation was single-blind as the surgeons did not know the result of the previous detection and were aware of the results only after the thirtieth procedure. RESULTS: The mean detection rate was 75% during the first procedure and reached 95% (or 5% detection errors) at the 30th procedure (p<0.0001; OR=6.33 with a 95% CI=[2.31; 17.33]). Proficiency in sentinel lymph node (SLN) identification also increased with the number of procedures performed. The ability to localize SLN improved during the learning phase with the increasing number of procedures performed. Mean detection time during the 30 procedures was 150 s (range: 115-210 s). CONCLUSIONS: Training on a phantom showed that this is a valuable teaching tool that enables surgeons to become familiar with gamma probes. It cannot replace the clinical training phase, but is an important aid to proficiency in intraoperative detection.

Implementing sentinel lymph node biopsy programs in developing countries: challenges and opportunities.

BACKGROUND: Sentinel lymph node biopsy (SLNB) is the accepted standard of care in early-stage breast cancer and cutaneous melanoma. This technology is accurate for nodal staging and determining the prognosis of these patients. There are several randomized controlled trials confirming the accuracy of this technique and confirming its role in reducing morbidity and improving quality of life. It is also gaining increased acceptance in the management of other solid tumors. Despite the established benefits of SLNB as a minimally invasive approach for nodal staging, the procedure is still underutilized in many developing countries. METHODS: The Human Health Division of the International Atomic Energy Agency (IAEA) convened advisory meetings with panels of multidisciplinary experts from different backgrounds with the remit to analyze the difficulties encountered by developing countries in establishing a successful SLNB program. The other remit of the panel was to recommend an effective program based on existing evidence that can be adapted and implemented in developing countries. The experience of some members of the panel in the training for this technique in Asia, Latin America, and Africa provided the insight required for the development of a comprehensive and structured program. The panel included recommendations on the technical aspects of the procedure, as well as a comprehensive training program, including theoretical teaching, practical training in surgical skills, laboratories, and hands-on proctored learning. Particular emphasis was placed on in-built quality assurance requirements to ensure that this powerful staging investigation is implemented with the highest possible standard in the management of cancer patients, with the lowest false negative rate. CONCLUSIONS: It is hoped that this article will be a useful resource for our colleagues planning to establish a SLNB program.

Quality of mesorectum after laparoscopic resection for rectal cancer - results of an audited teaching programme in Spain.

OBJECTIVE: The aim of this prospective observational study was to compare the quality of total mesorectal excision between laparoscopic and open surgery for rectal cancer. METHOD: In April 2006, the Spanish Association of Surgeons started an audited teaching programme. The project was similar to the Norwegian one and several training courses were arranged. Patients were classified into two groups: laparoscopic rectal resection (LR) and open rectal resection (OR). The quality of the mesorectum was scored: complete, nearly complete or incomplete. The circumferential margin (CRM) was considered positive, if tumour was located 1 mm or less from the surface of the specimen. RESULTS: Between 2006 and 2008, 604 patients underwent rectal resection with total mesorectal excision for rectal cancer: 209 patients were included in the LR group and 395 patients in the OR group. There were no differences in terms of number of lymph nodes affected, distance of the tumour from CRM. The mesorectum was complete in 464 (76.8%), nearly complete in 91 (15.1%) and incomplete in 49 patients (8.1%). CRM was negative in 534 patients (88.4%). No differences were observed between the two groups. The overall postoperative morbidity rate was 38.8% in LR group and 44.6% in OR group (P = 0.170). Overall postoperative mortality rate was 2.5%. One patient died (0.5%) in the LR group and 14 patients died (3.5%) in the OR group (P = 0.021). CONCLUSION: Laparoscopic resection for rectal cancer is feasible with the quality of mesorectal excision and postoperative outcomes similar to those of open surgery.

Surgeon training, protocol compliance, and technical outcomes from breast cancer sentinel lymph node randomized trial.

BACKGROUND: The National Surgical Adjuvant Breast and Bowel Project B-32 trial was designed to determine whether sentinel lymph node resection can achieve the same therapeutic outcomes as axillary lymph node resection but with fewer side effects and is one of the most carefully controlled and monitored randomized trials in the field of surgical oncology. We evaluated the relationship of surgeon trial preparation, protocol compliance audit, and technical outcomes. METHODS: Preparation for this trial included a protocol manual, a site visit with key participants, an intraoperative session with the surgeon, and prerandomization documentation of protocol compliance. Training categories included surgeons who submitted material on five prerandomization surgeries and were trained by a core trainer (category 1) or by a site trainer (category 2). An expedited group (category 3) included surgeons with extensive experience who submitted material on one prerandomization surgery. At completion of training, surgeons could accrue patients. Two hundred twenty-four surgeons enrolled 4994 patients with breast cancer and were audited for 94 specific items in the following four categories: procedural, operative note, pathology report, and data entry. The relationship of training method; protocol compliance performance audit; and the technical outcomes of the sentinel lymph node resection rate, false-negative rate, and number of sentinel lymph nodes removed was determined. All statistical tests were two-sided. RESULTS: The overall sentinel lymph node resection success rate was 96.9% (95% confidence interval [CI] = 96.4% to 97.4%), and the overall false-negative rate was 9.5% (95% CI = 7.4% to 12.0%), with no statistical differences between training methods. Overall audit outcomes were excellent in all four categories. For all three training groups combined, a statistically significant positive association was observed between surgeons' average number of procedural errors and their false-negative rate (rho = +0.188, P = .021). CONCLUSIONS: All three training methods resulted in uniform and high overall sentinel lymph node resection rates. Subgroup analyses identified some variation in false-negative rates that were related to audited outcome performance measures.

Sentinel lymph node biopsy for breast cancer using methylene blue dye manifests a short learning curve among experienced surgeons: a prospective tabular cumulative sum (CUSUM) analysis.

BACKGROUND: The benefits of sentinel lymph node biopsy (SLNB) for breast cancer patients with histologically negative axillary nodes, in whom axillary lymph node dissection (ALND) is thereby avoided, are now established. Low false negative rate, certainly with blue dye technique, mostly reflects the established high inherent accuracy of SLNB and low axillary nodal metastatic load (subject to patient selection). SLN identification rate is influenced by volume, injection site and choice of mapping agent, axillary nodal metastatic load, SLN location and skill at axillary dissection. Being more subject to technical failure, SLN identification seems to be a more reasonable variable for learning curve assessment than false negative rate. Methylene blue is as good an SLN mapping agent as Isosulfan blue and is much cheaper. Addition of radio-colloid mapping to blue dye does not achieve a sufficiently higher identification rate to justify the cost. Methylene blue is therefore the agent of choice for SLN mapping in developing countries. The American Society of Breast Surgeons recommends that, for competence, surgeons should perform 20 SLNB but admits that the learning curve with a standardized technique may be "much shorter". One appropriate remedy for this dilemma is to plot individual learning curves. METHODS: Using methylene blue dye, experienced breast surgeons performed SLNB in selected patients with breast cancer (primary tumor < 5 cm and clinically negative ipsilateral axilla). Intraoperative assessment and completion ALND were performed for standardization on the first 13 of 24 cases. SLN identification was plotted for each surgeon on a tabular cumulative sum (CUSUM) chart with sequential probability ratio test (SPRT) limits based on a target identification rate of 85%. RESULTS: The CUSUM plot crossed the SPRT limit line after 8 consecutive, positively identified SLN, signaling achievement of an acceptable level of competence. CONCLUSION: Tabular CUSUM charting, based on a justified choice of parameters, indicates that the learning curve for SLNB using methylene blue dye is completed after 8 consecutive, positively identified SLN. CUSUM charting may be used to plot individual learning curves for trainee surgeons by applying a proxy parameter for failure in the presence of a mentor (such as failed SLN identification within 15 minutes).

Dermatology - a surgical discipline - as exemplified by surgical procedures at the Hospital of Munich Thalkirchner Strasse.

BACKGROUND: Despite the enormous progress in dermatosurgery during the last 35 years,this achievement is not always appropriately acknowledged by other surgical specialties. We outline the significance of dermatosurgery by looking at the development of dermatological operations at the Department of Dermatology,University of Munich/Hospital of Munich Thalkirchner Strasse. PATIENTS AND METHODS: Data were collected and analyzed from surgery records, tables and from the SAP ISH-Med.The survey covered the time frame from 1971 to 2006. RESULTS: There were 101,103 inpatient operations. The number of operations per year increased steadily,especially the number of medium-sized and large operations. A special domain of dermatosurgery is the sentinel lymph node biopsy in patients with malignant melanoma. In the last years, there was a continuous increase of patients in whom more than one tumor had to be excised. The percentage of patients undergoing dermatosurgery was constant at 46% of all inpatients. CONCLUSIONS: The surgical therapy of skin tumors is the most important part of inpatient treatment of dermatology patients. The development of dermatosurgery shows that due to the increase of skin tumors and the opening of new fields of activity (for example the removal of sentinel lymph nodes) there is a growing demand for dermatological surgeons. Solid training and competent representation in dermatology and attention to our interactions with other surgical specialties will help guarantee optimal patient care in the future.

Sentinel lymph node biopsy in the treatment of breast cancer. Experience in 527 cases.

AIM: Knowledge of axillary lymph node status is a key aid to staging and prognosis and it represents a guideline for adjuvant therapy in breast cancer. Despite the morbidity it causes, complete axillary dissection was long the mainstay of treatment. Sentinel lymph node biopsy has proved so reliable in the evaluation of node involvement that axillary node dissection is now generally performed when sentinel node biopsy tests negative. METHODS: In this 3-phase study, 50 patients were enrolled to evaluate the learning curve of sentinel node biopsy (phase 1, September 1997-January 1998); 256 patients (age range 27-81 years) with infiltrative breast cancer (T <3 cm, clinical N0) underwent level 1 lymph node dissection when the sentinel node tested negative at histopathology (phase 2, February 1998-March 2001); 221 patients with T <3 cm underwent dissection of the sentinel node when it tested negative for metastasis (phase 3, April 2001-March 2005). RESULTS: The sentinel node was preoperatively detected in 98.6% of cases after peritumoral and intradermic injection of the radionuclide tracer and intraoperatively in 99% (90% with radio-guided surgery, 10% with vital staining). The sentinel node was positive in 15% of patients with T1 and metastatic in 65%. CONCLUSIONS: Our results are in line with the published data; therefore, the study will go forward to examine the role of the micrometastasis in the sentinel node and of in-transit tumoral cells.

A computerized gamma probe simulator to train surgeons in the localization of sentinel nodes.

BACKGROUND: The technique of sentinel node biopsy (SNB) may be used as a staging technique for cancer patients. SNB involves the localization of lymph nodes that have accumulated a radioactive tracer, and this requires surgeons to gain and demonstrate skills in the use of hand-held radiation detectors (gamma probes). METHODS: A computerized gamma probe simulator (GAPS) has been developed as a training tool to provide realistic simulations of the clinical distribution of radioactivity, without the use of radioactive materials, and a realistic simulation of the count rate response from a gamma probe. Electromagnetic spatial tracking of the surgeon's movement of the probe allows objective assessment of the user's accuracy in localizing a virtual sentinel node. The physical accuracy of the simulation has been validated, with a spatial accuracy of (0.06 mm), and a count rate error of 0.28%. RESULTS: The GAPS has been used in the training of 94 breast surgeons, with a mean error node localization of 3.8 mm (range, 0.1-16 mm) and a mean search time of 131 s (range 36-314 s), showing that objective feedback on performance can be given by the system. Modification to train for other sentinel node applications is simple, and the system has been used for training in the application of penile sentinel node surgery. CONCLUSION: A computerized gamma probe simulator has been developed which provides realistic training tasks for surgeons in sentinel node biopsy, with a wide range of simulated clinical cases, allowing the objective assessment of a trainee's performance in the use of a hand-held gamma probe without the use of radioactive sources.

[Internal mammary lymph nodes identification from isolated sternum of human cadaver]. / Identificação de linfonodos da cadeia mamária interna em esternos isolados de cadáver humano.

PURPOSE: To identify the lymph nodes positioned along the internal mammary vessels in isolated sternum of human cadaver and to standardize the surgical approach to those nodes, in order to establish anatomical landmarks to be used with the current techniques of mammary gland sentinel lymph node detection. METHODS: Ten sternum plates removed from unclaimed cadavers were used in this study. Sternal plates were removed using bilateral incisions of the ribs at the midclavicular lines. The characterization of the internal mammary vessels and the anatomical integrity of the parietal pleura were indispensable requirements during the procedure. RESULTS: A total of 29 lymph nodes were removed from the 2nd (13) and the 3rd (16) intercostals spaces. Almost 50% of all nodes collected were located medially to the vessels. CONCLUSION: The approach used is a reliable surgical technique for removing lymph node from sternal plates. The model is therefore valuable for breast surgeons training in sentinel node biopsy, an important procedure for breast cancer patients.