Surgical quality assessment for the prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for nonmetastatic right colon cancer (PIONEER study).

BACKGROUND: The modified complete mesocolic excision (mCME) procedure for right-sided colon cancer is a tailored approach based on the original complete mesocolic excision (CME) methodology. Limited studies evaluated the safety and feasibility of laparoscopic mCME using objective surgical quality assessments in patients with right colon cancer. The objectives of the PIONEER study were to evaluate oncologic outcomes after laparoscopic mCME and to identify optimal clinically relevant endpoints and values for standardizing laparoscopic right colon cancer surgery based on short-term outcomes of procedures performed by expert laparoscopic surgeons. MATERIALS AND METHODS: This is an ongoing prospective, multi-institutional, single-arm study conducted at five tertiary colorectal cancer centers in South Korea. Study registrants included 250 patients scheduled for laparoscopic mCME with right-sided colon adenocarcinoma (from the appendix to the proximal half of the transverse colon). The primary endpoint was 3-year disease-free survival. Secondary outcomes included 3-year overall survival, incidence of morbidity in the first 4 weeks postoperatively, completeness of mCME, central radicality, and distribution of metastatic lymph nodes. Survival data will be available after the final follow-up date (June 2024). RESULTS: The postoperative complication rate was 12.9%, with a major complication rate of 2.7%. In 87% of patients, central radicality was achieved with dissection at or beyond the level of complete exposure of the superior mesenteric vein. Mesocolic plane resection with an intact mesocolon was achieved in 75.9% of patients, as assessed through photographs. Metastatic lymph node distribution varied by tumor location and extent. Seven optimal clinically relevant endpoints and values were identified based on the analysis of complications in low-risk patients. CONCLUSIONS: Laparoscopic mCME for right-sided colon cancer produced favorable short-term postoperative outcomes. The identified optimal clinically relevant endpoints and values can serve as a reference for evaluating surgical performance of this procedure.

Assessment of Laparoscopic Indocyanine Green Tracer-guided Lymphadenectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Controlled Trial.

OBJECTIVE: To assess the effectiveness of indocyanine green (ICG)-guided lymph node (LN) dissection during laparoscopic radical gastrectomy after neoadjuvant chemotherapy (NAC) in patients with locally advanced gastric cancer (LAGC). BACKGROUND: Studies on ICG imaging use in patients with LAGC on NAC are rare. METHODS: Patients with gastric adenocarcinoma (clinical T2-4NanyM0) who received NAC were randomly assigned to receive ICG-guided laparoscopic radical gastrectomy or laparoscopic radical gastrectomy alone. Here, we reported the secondary endpoints including the quality of lymphadenectomy (total retrieved LNs and LN noncompliance) and surgical outcomes. RESULTS: Overall, 240 patients were randomized. Of whom, 236 patients were included in the primary analysis (118 in the ICG group and 118 in the non-ICG group). In the ICG group, the mean number of LNs retrieved was significantly higher than in the non-ICG group within the D2 dissection (48.2 vs 38.3, P < 0.001). The ICG fluorescence guidance significantly decreased the LN noncompliance rates (33.9% vs 55.1%, P = 0.001). In 165 patients without baseline measurable LNs, ICG significantly increased the number of retrieved LNs and decreased the LN noncompliance rate ( P < 0.05). For 71 patients with baseline measurable LNs, the quality of lymphadenectomy significantly improved in those who had a complete response ( P < 0.05) but not in those who did not ( P > 0.05). Surgical outcomes were comparable between the groups ( P > 0.05). CONCLUSIONS: ICG can effectively improve the quality of lymphadenectomy in patients with LAGC who underwent laparoscopic radical gastrectomy after NAC.

Comparison of 3D and 2D laparoscopy: Initial experience of perioperative outcomes and clinical assessment.

INTRODUCTION: This study was designed to compare three-dimensional (3D) laparoscopy and conventional two-dimensional (2D) laparoscopy in surgical performance and clinical assessment during laparoscopic radical hysterectomy with pelvic lymphadenectomy (LRHND) for treating early-stage cervical cancer. MATERIAL AND METHODS: In this study, we included 67 consecutive patients underwent LRHND for treating early-stage cervical cancer by the experienced laparoscopic surgeons between August 2018 and December 2020. amongst these patients, 32 patients underwent 3D laparoscopy (2D group) and 35 patients underwent 2D laparoscopy (2D group). Demographic data, clinical and surgical parameters were obtained from each patient. An end-of-operation questionnaire was administered regarding subjective perception of 3D laparoscopy system. RESULTS: Patient characteristics, including age, BMI, FIGO stage, and histology, were comparable between the two groups. Compared with 2D imaging system, 3D system significantly shortened the operation time, especially bilateral lymph node dissection time. Blood loss was lower in 3D group compared with 2D group. There were no significant differences regarding pelvic nodes retrieved, incidence of complications, hospital stay, the recovery time of bowel, abdominal drainage fluid, hospitalization costs and visual symptoms. In addition, 3D system significantly improved depth perception and precision, and reduced surgical strain and eye strain for surgeon. No statistical difference was observed in visual symptoms and adverse events between the two groups. The surgeon was more willing to accept 3D laparoscopy. CONCLUSION: The 3D laparoscopy is safe, feasible and comfortable, with obvious advantage in depth perception, precision and surgical strain. It triggered no increase in the complications and adverse events.

The incidence and cost implications of surgical site infection following lymph node surgery for skin malignancy.

BACKGROUND: Lymph node surgery is commonly performed in the staging and treatment of metastatic skin cancer. Previous studies have demonstrated sentinel lymph node biopsy (SLNB) and, particularly, lymph node dissection (LND) to be plagued by high rates of wound complications, including surgical site infection (SSI) and seroma formation. This study evaluated the incidence of wound complications following lymph node surgery and provided the first published cost estimate of SSI associated with lymph node surgery in the UK. PATIENTS AND METHODS: A retrospective cohort study of 169 patients with a histological diagnosis of primary skin malignancy who underwent SLNB or LND of the axilla and/or inguinal region at a single tertiary centre over a 2 year period was conducted. Demographic, patient risk factor, and operation characteristics data were collected and effect on SSI and seroma formation was analysed. Cost-per-infection was estimated using National Health Service (NHS) reference and antibiotic costs. RESULTS: A total of 146 patients underwent SLNB with a SSI rate of 4.1% and a seroma incidence of 12.3%. Twenty-three patients underwent LND with a SSI rate of 39.1% and a seroma incidence of 39.1%. Seroma formation was strongly associated with the development of SSI in both the SLNB (odds ratio (OR) = 18.0, p < 0.001) and LND (OR = 21.0, p = 0.007) group. The median additional cost of care events and treatment of SSI in the SLNB and LND groups was £199.46 and £5187.04, respectively. CONCLUSION: SSI remains a troublesome and costly event following SLNB and LND. Further research into perioperative care protocols and methods of reducing lymph node surgery morbidity is required and could result in significant cost savings to the NHS.

Sentinel lymph node assessment in melanoma: current state and future directions.

Assessment of sentinel lymph node status is an important step in the evaluation of patients with melanoma for both prognosis and therapeutic management. Pathologists have an important role in this evaluation. The methodologies have varied over time, from the evaluation of dimensions of metastatic burden to determination of the location of the tumour deposits within the lymph node to precise cell counting. However, no single method of sentinel lymph node tumour burden measurement can currently be used as a sole independent predictor of prognosis. The management approach to sentinel lymph node-positive patients has also evolved over time, with a more conservative approach recently recognised for selected cases. This review gives an overview of past and current status in the field with a glimpse into future directions based on prior experiences and clinical trials.

Outcomes for patients with high-risk endometrial cancer undergoing sentinel lymph node assessment versus full lymphadenectomy.

OBJECTIVE: The objective of this study was to determine the progression free survival (PFS) and overall survival (OS) among patients with high-risk endometrial cancer (EC) who underwent sentinel lymph node (SLN) mapping and dissection compared to patients who underwent pelvic +/- para-aortic lymphadenectomy (LND). METHODS: Patients with newly diagnosed high-risk EC were identified. Inclusion criteria included patients who underwent primary surgical management from January 1, 2014 to September 1, 2020 at our institution. Patients were categorized into either the SLN or LND group based on their method of planned lymph node assessment. Patients in the SLN group had dye injected followed by successful bilateral lymph node mapping, retrieval, and processing per our institutional protocol. Clinicopathological and follow-up data were extracted from patient's medical records. The t-test or Mann-Whitney test was used to compare continuous variables and Chi-squared or Fisher's exact test were used for categorical variables. Progression-free survival (PFS) was calculated from the date of initial surgery to the date of progression, death, or last follow-up. Overall survival (OS) was calculated from the date of surgical staging to the date of death or last follow-up. Three-year PFS and OS were calculated using the Kaplan-Meier method, and the log-rank test was used to compare cohorts. Multivariable Cox regression models were used to assess the relationship between nodal assessment cohort and OS/PFS while adjusting for age, adjuvant therapy, and surgical approach. A result was considered statistically significant at the p < 0.05 level of significance and all statistical analysis was done using SAS version 9.4 (SAS Institute, Cary, NC). RESULTS: Out of 674 patients diagnosed with EC during the study period, 189 were diagnosed with high-risk EC based on our criteria. Forty-six (23.7%) patients underwent SLN assessment and 143 (73.7%) underwent LND. No difference was observed between the two groups in regards to age, histology, stage, body mass index, tumors myometrial invasion, lymphovascular space invasion, or peritoneal washing positivity. Patients in the SLN group underwent robotic-assisted procedures more frequently than those in the LND group (p < 0.0001). The three-year PFS rate was 71.1% (95% CI 51.3-84.0%) in the SLN group and 71.3% (95% CI 62.0-78.6%) in the LND group (p = 0.91). The unadjusted hazard ratio (HR) for recurrence in the SLN versus LND group was 1.11 (95% CI 0.56-2.18; p = 0.77), and after adjusting for age, adjuvant therapy, and surgical approach, the HR for recurrence was 1.04 (95% CI 0.47-2.30, p = 0.91). The three-year OS rate was 81.1% (95% CI 51.1-93.7%) in the SLN group and 95.1% (95% CI 89.4-97.8%) in the LND group (p = 0.009). Although the unadjusted HR for death was 3.74 in the SLN vs LND group (95% CI 1.39-10.09; p = 0.009), when adjusted for age, adjuvant therapy, and surgical approach, it was no longer significant with a HR of 2.90 (95% CI 0.94-8.95, p = 0.06). CONCLUSIONS: There was no difference in three-year PFS in patients diagnosed with high-risk EC who underwent SLN evaluation compared to those who underwent full LND in our cohort. The SLN group did experience shorter unadjusted OS; however, when adjusting for age, adjuvant therapy and surgical approach, there was no difference OS in patients who underwent SLN compared to LND.

Clinical and cost outcomes of a polyethylene glycol (PEG)-coated patch versus drainage after axillary lymph node dissection in breast cancer: results from a multicentre randomized clinical trial.

BACKGROUND: The aim of this study was to compare the clinical outcomes between breast cancer patients who underwent axillary lymph node dissection with postoperative management using a polyethylene glycol-coated patch versus axillary drainage. The direct costs associated with both postoperative management strategies were also evaluated. METHODS: This was a multicentre RCT in women with breast cancer who underwent axillary lymph node dissection (ClinicalTrials.gov identifier: NCT04487561). Patients were randomly assigned (1 : 1) to receive either drainage or a polyethylene glycol-coated patch as postoperative management. The primary endpoints were the need for an emergency department visit for any event related to the surgery and the rate of seroma development. RESULTS: A total of 227 patients were included , 115 in the patch group (50.7 per cent) and 112 (29.4 per cent ) in the drainage group. The incidence of emergency department visits was significantly greater for patients with drainage versus a polyethylene glycol-coated patch (incidence rate difference 26.1 per cent, 95 per cent c.i. 14.5 to 37.7 per cent; P < 0.001). Conversely, the seroma rate was significantly higher in the polyethylene glycol-coated patch group (incidence rate difference 22.8 per cent, 95 per cent c.i. 6.7 to 38.9 per cent; P < 0.0055). Compared with drainage, using a polyethylene glycol-coated patch resulted in cost savings of €100.41 per patient. An incremental cost-effectiveness ratio analysis found that drainage was associated with an incremental cost-effectiveness ratio of €7594.4 for no need for hospital admission and €491.7 for no need for an emergency department visit. CONCLUSION: Compared with patients who received drainage after axillary lymph node dissection, the use of a polyethylene glycol-coated patch resulted in a higher rate of seroma, but a lower number of postoperative outpatient or emergency department visits and thus a reduction in overall costs.

Low-Cost and Reproductible Method to Obtain Mapping of Lymphatic Drainage in Patient with Early Endometrial Cancer.

Introduction: Endometrial cancer is the most common form of gynecological cancer in developed countries. Current recommended therapeutic management takes into account a number of factors such as: TNM stage, justification for primary surgery, desire to preserve fertility. For primary operable cases, surgical staging has become an extremely important pillar, in which the status of the pelvic lymph nodes needs to be known (1-3). Material and Method: Between August 2015 and June 2021, a multicenter prospective observational study was performed in the "Prof. Dr. I. Chiricuta" Oncological Institute Cluj Napoca, 2nd Department of Surgery of "Pius Brinzeu" County Hospital Timisoara, 1st Department of General Surgery of Arad County Hospital, 2nd Department of Obstetrics and Gynecology "Dominic Stanca" Cluj Napoca and "Dr. Carol Davila" Central Military Emergency University Hospital Bucharest, Romania with the main aim of examining the sentinel lymph node detection rate using methylene blue as a tracer. Surgeries were performed by the team of surgeons of the mentioned clinics, and patients were informed about this study and signed an informed consent form for enrollment. Results: A total of 116 cases met the inclusion criteria for this prospective study. The mean age of the included patients was 62.3 years (minimum - 38, maximum - 83). The mean body mass index was 31.8 (minimum - 19.9, maximum - 48.2). In terms of histological type of the endometrial cancer, the majority of cases were endometrioid cancer, amounting to 72.5% of the total (n=84). A considerable number of cases were of mixed type, either with clear cell carcinoma (8.6%, n=10) or mixed carcinosarcoma (17.2%, n=20). The preferred approach for surgery was laparoscopic surgery rather than traditional surgery (72% vs 28%). Another element investigated from a histological point of view is the tumour grading, the degree of differentiation of cells with anarchic development, we note that 50% (n=58) were G2. Of the 116 cases of endometrial carcinoma included in the study, in 83% of cases (n=96) methylene blue tracer injection was successful and sentinel node was identified. The SLN technique continues to be of great interest and use in surgical centers around the world. The method of detecting sentinel lymph nodes varies depending on the individual. According to literature studies, indocyanine (ICG- Indocyanine green) is the gold standard for lymph node mapping, with superior detection rates when compared to other existing versions. Another key factor to consider when selecting a sentinel node identification method is cost-effectiveness. The use of methyl blue as a marker tracer is the most cost-effective option with equivalent detection rate outcomes. Conclusions: Based on the results of our study and other studies in the literature, lymphatic mapping using methylene blue as a tracer in endometrial cancer is a cost-effective method with a favourable detection rate. With this low-cost procedure we can achieve a correct tumor staging, avoiding overtreatment. There are multiple ways to identify the sentinel node using different tracers with higher accuracy, but the objective of the study was not to make a comparison between different tracers, but to present the feasibility of lymph node mapping using methylene blue as a low cost tracer with good reproducibility, short learning curve and optimal detection rate.

German specialists treating testicular cancer follow different guidelines with resulting inconsistency in assessment of retroperitoneal lymph-node metastasis: clinical implications and possible corrective measures.

BACKGROUND: Testicular germ cell tumors (GCTs) are aggressive but highly curable tumors. To avoid over/undertreatment, reliable clinical staging of retroperitoneal lymph-node metastasis is necessary. Current clinical guidelines, in their different versions, lack specific recommendations on how to measure lymph-node metastasis. OBJECTIVE: We aimed to assess the practice patterns of German institutions frequently treating testicular cancer for measuring retroperitoneal lymph-node size. METHODS: An 8-item survey was distributed among German university hospitals and members of the German Testicular Cancer Study Group. RESULTS: In the group of urologists, 54.7% assessed retroperitoneal lymph nodes depending on their short-axis diameter (SAD) (33.3% in any plane, 21.4% in the axial plane), while 45.3% used long-axis diameter (LAD) for the assessment (42.9% in any plane, 2.4% in the axial plane). Moreover, the oncologists mainly assessed lymph-node size based on the SAD (71.4%). Specifically, 42.9% of oncologists assessed the SAD in any plane, while 28.5% measured this dimension in the axial plane. Only 28.6% of oncologists considered the LAD (14.3% in any plane, 14.3% in the axial plane). None of the oncologists and 11.9% of the urologists (n = 5) always performed an MRI for the initial assessment, while for follow-up imaging, the use increased to 36.5% of oncologists and 31% of urologists. Furthermore, only 17% of the urologists, and no oncologists, calculated lymph-node volume in their assessment (p = 0.224). CONCLUSION: Clear and consistent measurement instructions are urgently needed to be present in all guidelines across different specialistic fields involved in testicular cancer management.

Lymph node assessment technique matters in radical cystectomy for bladder cancer.

BACKGROUND: For patients undergoing radical cystectomy with pelvic lymph node dissection for urothelial cancer, a lymph node count of at least 16 is associated with improved cancer-specific and overall survival. Lymph node yield is presumed to relate directly to extent of dissection and surgical quality, however limited studies have reviewed the impact of the pathological assessment process of lymph nodes on lymph node yield. METHOD: A retrospective assessment of 139 patients who had radical cystectomy for urothelial cancer between March 2015 and July 2021 from Fiona Stanley Hospital (Perth, Australia) by a single surgeon was assessed. A change in pathological assessment process from assessment of only palpable lymph nodes to microscopic assessment of the entire submitted specimens occurred in August 2018. Patients were divided into two groups accordingly and other relevant demographic and pathological data was recorded. The impact of pathological processing technique on lymph node yield was assessed using the Student T test and logistical regression was used to assess the impact of other demographic variables. RESULTS: The mean lymph node yield was 16.2 nodes (IQR 12-23) in 54 patients in the pre-process change group compared to 22.4 nodes (IQR 15-28.4) in 85 patients in the post-process change group (P < 0.0001). 53.7% had 16 or more nodes in the pre-process change group compared to 71.3% in the post-process change group (P = 0.04). Age, BMI, and gender were not significant predictors of lymph node yield. CONCLUSION: The current study demonstrates that the microscopic assessment of all lymph node tissue detects significantly more lymph nodes than only examining palpably abnormal tissue. Pathologic assessment protocols should be standardized to this technique to ensure the utility of lymph node yield as a quality metric.

Simple radiologic assessment of visceral obesity and prediction of surgical morbidity in endometrial cancer patients undergoing laparoscopic aortic lymphadenectomy: A reliability and accuracy study.

AIM: To evaluate the reliability of sagittal abdominal diameter (SAD)-a surrogate of visceral obesity-in magnetic resonance imaging, and its accuracy to predict the surgical morbidity of aortic lymphadenectomy. METHODS: We conducted a multicenter reliability (phase 1) and accuracy (phase 2) cohort study in three Spanish referral hospitals. We retrospectively analyzed data from the STELLA-2 randomized controlled trial that included high-risk endometrial cancer patients undergoing minimally invasive surgical staging. Patients were classified into subgroups: conventional versus robotic-assisted laparoscopy, and transperitoneal versus extraperitoneal technique. In the first phase, we measured the agreement of three SAD measurements (at the umbilicus, renal vein, and inferior mesenteric artery) and selected the most reliable one. In phase 2, we evaluated the diagnostic accuracy of SAD to predict surgical morbidity. Surgical morbidity was the main outcome measure, it was defined by a core outcome set including variables related to blood loss, operative time, surgical complications, and para-aortic lymphadenectomy difficulty. RESULTS: In phase 1, all measurements showed good inter-rater and intra-rater agreement. Umbilical SAD (u-SAD) was the most reliable one. In phase 2, we included 136 patients. u-SAD had a good diagnostic accuracy to predict surgical morbidity in patients undergoing transperitoneal laparoscopic lymphadenectomy (0.73 in ROC curve). It performed better than body mass index and other anthropometric measurements. We calculated a cut-off point of 246 mm (sensitivity: 0.56, specificity: 0.80). CONCLUSIONS: u-SAD is a simple, reliable, and potentially useful measurement to predict surgical morbidity in endometrial cancer patients undergoing minimally invasive surgical staging, especially when facing transperitoneal aortic lymphadenectomy.

Assessment and Reporting of Perioperative Adverse Events and Complications in Patients Undergoing Inguinal Lymphadenectomy for Melanoma, Vulvar Cancer, and Penile Cancer: A Systematic Review and Meta-analysis.

BACKGROUND: Inguinal lymph node dissection (ILND) plays a crucial role in the oncological management of patients with melanoma, penile, and vulvar cancer. This study aims to systematically evaluate perioperative adverse events (AEs) in patients undergoing ILND and its reporting. METHODS: A systematic review was conducted according to PRISMA. PubMed, MEDLINE, Scopus, and Embase were queried to identify studies discussing perioperative AEs in patients with melanoma, penile, and vulvar cancer following ILND. RESULTS: Our search generated 3.469 publications, with 296 studies meeting the inclusion criteria. Details of 14.421 patients were analyzed. Of these studies, 58 (19.5%) described intraoperative AEs (iAEs) as an outcome of interest. Overall, 68 (2.9%) patients reported at least one iAE. Postoperative AEs were reported in 278 studies, combining data on 10.898 patients. Overall, 5.748 (52.7%) patients documented ≥1 postoperative AEs. The most reported ILND-related AEs were lymphatic AEs, with a total of 4.055 (38.8%) events. The pooled meta-analysis confirmed that high BMI (RR 1.09; p = 0.006), ≥1 comorbidities (RR 1.79; p = 0.01), and diabetes (RR 1.81; p = < 0.00001) are independent predictors for any AEs after ILND. When assessing the quality of the AEs reporting, we found 25% of studies reported at least 50% of the required criteria. CONCLUSION: ILND performed in melanoma, penile, and vulvar cancer patients is a morbid procedure. The quality of the AEs reporting is suboptimal. A more standardized AEs reporting system is needed to produce comparable data across studies for furthering the development of strategies to decrease AEs.

Current practices concerning the assessment and treatment of lateral lymph nodes in low rectal cancer: a survey among colorectal surgeons in The Netherlands.

PURPOSE: The presence of lateral lymph nodes (LLNs) in patients with rectal cancer is not always acknowledged by the multidisciplinary team or treated in a standardized manner, and (inter)national guidelines concerning this topic are lacking. This study aimed to evaluate current practices regarding the assessment and treatment of LLNs in rectal cancer patients based on a survey among Dutch colorectal surgeons. METHODS: An online survey was sent to members of the Dutch Association of Coloproctology. The survey consisted of 16 questions addressing their views on diagnosis, restaging, and treatment approaches for suspicious LLNs. RESULTS: A total of 62 surgeons from 50 Dutch hospitals responded. For patients with a distal cT3/T4 rectal tumor; lateral lymph node compartments were routinely discussed during multidisciplinary meetings in only nine hospitals (18%). When defining what makes an LLN suspicious; the size threshold varied from >3 to >10 mm (median 7, SD 2), and MRI-based malignant features were mentioned by 29 surgeons (47%). Surgeons stated eight different treatment strategies as their designated treatment of suspicious LLNs. A total of 33 surgeons (53%) would add a radiotherapy boost to the neoadjuvant treatment. In cases of surgical resection; 12 surgeons (19%) would remove the suspicious LLN by 'node-picking' and 44 surgeons (71%) would perform a lateral lymph node dissection. The variation was not influenced by hospital type or surgeon's experience. CONCLUSION: These results highlight the vast variation in the awareness, definition of suspicious LLNs in rectal cancer, and different treatment approaches. International guidelines based on further research are warranted.

Development of a procedure-specific tool for skill assessment in left- and right-sided laparoscopic complete mesocolic excision.

AIM: To (1) develop an assessment tool for laparoscopic complete mesocolic excision (LCME) and (2) report evidence of its content validity. METHOD: Assessment statements were revealed through (1) semi-structured expert interviews and (2) consensus by the Delphi method, both involving an expert panel of five LCME surgeons. All experts were interviewed and then asked to rate LCME describing statements from 1 (strongly disagree) to 5 (strongly agree). Responses were returned anonymously to the panel until consensus was reached. Statements were directly included as content in the assessment tool if ≥60% of the experts responded "agree" or "strongly agree" (ratings 4 and 5), with the remaining responses being "neither agree nor disagree" (rating 3). Interclass correlation coefficient (ICC) was calculated for expert agreement evaluation. All included statements were subsequently reformulated as tool items and approved by the experts. RESULTS: Four Delphi rounds were performed to reach consensus. Disagreement was reported for statements describing instrument handling around pancreas; visualisation of landmarks before inferior mesenteric artery ligation; lymphadenectomy around the inferior mesenteric artery, and division of the terminal ileum and transverse colon. ICC in the last Delphi-round was 0.84. The final tool content included 73 statements, converted to 48 right- and 40 left-sided items for LCME assessment. CONCLUSION: A procedure-specific, video-based tool, named complete mesocolic excision competency assessment tool (CMECAT), has been developed for LCME skill assessment. In the future, we hope it can facilitate assessment of LCME surgeons, resulting in improved patient outcome after colon cancer surgery.

Metabolic and magnetic resonance imaging: complementary modalities for the preoperative assessment of lateral pelvic lymph nodes in rectal cancer.

BACKGROUND: The management of lateral pelvic lymph nodes for rectal cancer is a topical and controversial issue. The aim of this study was to assess the relationship between lateral pelvic lymph node features on magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) with oncological outcomes in patients with rectal cancer. METHODS: A retrospective analysis of 284 patients with primary locally advanced rectal cancer treated with neoadjuvant therapy and surgical resection with curative intent between January 2003 and Dec 2018 was undertaken. From this study population, a select cohort of 77 patients with abnormal lateral pelvic lymph nodes on preoperative imaging had imaging re-analysed by radiologists blinded to clinical outcomes. Pre and post neoadjuvant therapy MRI and PET-CT lateral pelvic lymph node features were correlated with oncological outcomes. RESULTS: A lateral pelvic lymph node short axis size ≥5 mm on post neoadjuvant therapy MRI was a significant predictor of worse 3-year local recurrence free survival (HR 8.35, P = 0.001). Lateral pelvic lymph node avidity on post neoadjuvant therapy PET-CT was a significant predictor of worse 3-year distant recurrence free survival (HR 5.62, P = 0.001). No correlation of oncological outcomes with overall survival was identified. CONCLUSION: Lateral pelvic lymph node imaging features on post-neoadjuvant therapy MRI and PET-CT predicted those at risk of rectal cancer recurrence. Further studies are required to confirm these findings that suggest restaging MRI and PET-CT are complementary modalities for the preoperative assessment of lateral pelvic lymph nodes in rectal cancer.

Inguinofemoral sentinel lymph node biopsy by scar injection in vulvar cancer: an assessment of feasibility and long-term outcomes.

BACKGROUND: Performing inguinofemoral sentinel lymph node biopsy for vulvar cancer following a previous vulvar excision, often referred to as 'scar injection', is debated. OBJECTIVE: To assess the feasibility of sentinel lymph node biopsy following scar injection and the long-term outcomes in patients undergoing this procedure. METHODS: We conducted a retrospective observational cohort study of patients with vulvar cancer. We assessed detection rates and outcomes in patients who underwent sentinel lymph node biopsy by scar injection and compared them with patients who had injection around a visible tumor and with patients who had an inguinofemoral lymphadenectomy following previous vulvar excision. Sentinel node detection rates are described per patient and per groin and are compared using Χ2 analysis. Cox regression analysis was used to assess the association of recurrence and survival with surgical technique and recognized pathological variables. RESULTS: Data were analyzed for 173 groins in 97 patients. At least one sentinel lymph node was detected in 162 (94%) groins examined, and detection rate did not differ whether the groin was assessed following tumor injection (n=122, 94%) or scar injection (n=40, 93%; p=0.85). Patients in the scar-injection group had less frequent lymph node metastases (p<0.02), smaller tumors (p<0.001), and more superficial invasion (p<0.02). Median follow-up was 34.7 months (range 0-108). Scar injection was not independently associated with recurrence or death on multivariable analysis, and depth of invasion was the only independent predictor of disease recurrence (hazards ratio (HR)=1.14, p=0.03). Recurrence and survival were also comparable for patients who had a sentinel lymph node biopsy or inguinofemoral lymphadenectomy following previous vulvar excision (log rank p=0.30; p=0.67). CONCLUSIONS: Sentinel lymph node biopsy by scar injection is feasible and demonstrates similar long-term outcomes in patients having scar or tumor injections, and in patients following previous tumor excision undergoing sentinel lymph node biopsy or lymphadenectomy.

The implementation of a noninvasive lymph node staging (NILS) preoperative prediction model is cost effective in primary breast cancer.

PURPOSE: The need for sentinel lymph node biopsy (SLNB) in clinically node-negative (cN0) patients is currently questioned. Our objective was to investigate the cost-effectiveness of a preoperative noninvasive lymph node staging (NILS) model (an artificial neural network model) for predicting pathological nodal status in patients with cN0 breast cancer (BC). METHODS: A health-economic decision-analytic model was developed to evaluate the utility of the NILS model in reducing the proportion of cN0 patients with low predicted risk undergoing SLNB. The model used information from a national registry and published studies, and three sensitivity/specificity scenarios of the NILS model were evaluated. Subgroup analysis explored the outcomes of breast-conserving surgery (BCS) or mastectomy. The results are presented as cost (€) and quality-adjusted life years (QALYs) per 1000 patients. RESULTS: All three scenarios of the NILS model reduced total costs (-€93,244 to -€398,941 per 1000 patients). The overall health benefit allowing for the impact of SLNB complications was a net health gain (7.0-26.9 QALYs per 1000 patients). Sensitivity analyses disregarding reduced quality of life from lymphedema showed a small loss in total health benefits (0.4-4.0 QALYs per 1000 patients) because of the reduction in total life years (0.6-6.5 life years per 1000 patients) after reduced adjuvant treatment. Subgroup analyses showed greater cost reductions and QALY gains in patients undergoing BCS. CONCLUSION: Implementing the NILS model to identify patients with low risk for nodal metastases was associated with substantial cost reductions and likely overall health gains, especially in patients undergoing BCS.

Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery from an Italian hospital perspective.

BACKGROUND: Mastectomy or breast conserving surgery, both with axillary lymph node dissection, are common treatments for early-stage breast cancer. Monopolar electrocautery is typically used for both procedures, despite evidence of improved clinical outcomes with HARMONIC FOCUS™+. This analysis evaluated the budget impact of adopting HARMONIC FOCUS™+ versus monopolar electrocautery for patients undergoing these procedures from an Italian hospital perspective. METHODS: Total costs for an annual caseload of 100 patients undergoing mastectomy or breast conserving surgery, with axillary lymph node dissection, with either the intervention or comparator were calculated. Italian clinical and cost input data were utilised. The analysis included costs for the device, operating room time, postoperative length of stay, treating seroma and managing postoperative chest wall drainage. Deterministic and probabilistic sensitivity analyses assessed uncertainty of model input values. Two scenario analyses investigated the impact of conservative estimates of postoperative length of stay reduction and daily hospital cost on the simulated cost difference. RESULTS: HARMONIC FOCUS™+ achieves annual savings of EUR 100,043 compared with monopolar electrocautery, derived from lower costs for operating room time, postoperative length of stay and seroma and postoperative chest wall drainage management, offsetting the incremental device cost increase (EUR 43,268). Cost savings are maintained in scenario analyses and across all variations in parameters in deterministic sensitivity analysis, with postoperative hospital stay costs being key drivers of budget impact. The mean (interquartile range) cost savings with HARMONIC FOCUS™+ versus monopolar electrocautery in probabilistic sensitivity analysis are EUR 101,637 (EUR 64,390-137,093) with a 98% probability of being cost saving. CONCLUSIONS: The intervention demonstrates robust cost savings compared with monopolar electrocautery for mastectomy or breast conserving surgery, with axillary lymph node dissection, in an Italian hospital setting, and improved clinical and resource outcomes. These findings, with other clinical and cost analyses, support HARMONIC FOCUS™+ use in this setting.

Assessment of indocyanine green fluorescence lymphography on lymphadenectomy during minimally invasive gastric cancer surgery: a systematic review and meta-analysis.

BACKGROUND: In recent years, indocyanine green fluorescence lymphography has been introduced for lymphatic mapping in gastric cancer surgery. The aim of this study was to investigate the efficacy of ICGFL in lymph node dissection during minimally invasive surgery for gastric cancer. METHODS: A systematic review of electronic databases including PubMed, Embase, Web of Science, the Cochrane Library, and China National Knowledge Infrastructure was performed from the inception to January 2021 for all studies comparing ICGFL with non-ICGFL in GC patients undergoing minimal access gastrectomy. The primary outcome was the total number of harvested lymph nodes. The secondary endpoints were the number of metastatic LNs, operative time, estimated blood loss, and postoperative complications. The registration number of this protocol is PROSPERO CRD42020203443. RESULTS: A total of 13 studies including 1882 participants were included. In this meta-analysis, the use of ICGFL was associated with a higher number of harvested LNs (40.33 vs. 33.40; MD = 6.93; 95%CI: 4.28 to 9.58; P < 0.0001; I2 = 86%). No significant difference was found between the ICGFL and control groups in terms of metastatic LNs (2.63 vs. 2.42; MD = 0.21; 95%CI: -0.46 to 0.87; P = 0.54; I2 = 0%). In addition, the use of ICGFL could be safely performed without increasing the operative time (P = 0.49), estimated blood loss (P = 0.26) and postoperative complications (P = 0.54). CONCLUSION: The use of ICGFL may be a useful tool facilitating complete lymph node dissection during minimally invasive GC resection. However, more high-quality RCTs with large sample size are needed to validate this issue.