Risk Of Positive Surgical Margins Research Articles

Development of preoperative nomograms to predict the risk of overall and multifocal positive surgical margin after radical prostatectomy

ObjectiveTo develop preoperative nomograms using risk factors based on clinicopathological and MRI for predicting the risk of positive surgical margin (PSM) after radical prostatectomy (RP).Patients and methodsThis study retrospectively enrolled patients who underwent prostate MRI before RP at our center between January 2015 and November 2022. Preoperative clinicopathological factors and MRI-based features were recorded for analysis. The presence of PSM (overall PSM [oPSM]) at pathology and the multifocality of PSM (mPSM) were evaluated. LASSO regression was employed for variable selection. For the final model construction, logistic regression was applied combined with the bootstrap method for internal verification. The risk probability of individual patients was visualized using a nomogram.ResultsIn all, 259 patients were included in this study, and 76 (29.3%) patients had PSM, including 40 patients with mPSM. Final multivariate logistic regression revealed that the independent risk factors for oPSM were tumor diameter, frank extraprostatic extension, and annual surgery volume (all p < 0.05), and the nomogram for oPSM reached an area under the curve (AUC) of 0.717 in development and 0.716 in internal verification. The independent risk factors for mPSM included the percentage of positive cores, tumor diameter, apex depth, and annual surgery volume (all p < 0.05), and the AUC of the nomogram for mPSM was 0.790 in both development and internal verification. The calibration curve analysis showed that these nomograms were well-calibrated for both oPSM and mPSM.ConclusionsThe proposed nomograms showed good performance and were feasible in predicting oPSM and mPSM, which might facilitate more individualized management of prostate cancer patients who are candidates for surgery.

Centralized prostatectomy with intraoperative NeuroSAFE margin assessment improves surgical margin control.

To investigate the surgical margin status in patients with prostate cancer who underwent robot-assisted radical prostatectomy (RARP) with intraoperative neurovascular structure-adjacent frozen-section analysis (NeuroSAFE) and evaluate differences compared to patients who underwent radical prostatectomy without NeuroSAFE. Between September 2018 and January 2021, 962 patients underwent centralized RARP with NeuroSAFE. A secondary resection was performed in case of a positive surgical margin (PSM) on intraoperative frozen section (IFS) analysis to convert a PSM into a negative surgical margin (NSM). A retrospective cohort consisted of 835 patients who had undergone radical prostatectomy in a tertiary centre without NeuroSAFE between January 2000 and December 2017. We performed multivariable logistic regression to evaluate differences in risk of PSM between cohorts after controlling for clinicopathological variables. Patients operated with NeuroSAFE in the centralized clinic had 29% PSM at a definitive pathological RP examination. The median cumulative length of definitive PSM was 1.1 mm (interquartile range: 0.4-3.8). Among 275 men with PSM, 136 (49%) had a cumulative length ≤1 mm and 198 (72%) ≤3 mm. After controlling for PSA, Grade group, cribriform pattern, pT-stage, and pN-stage, patients treated in the centralized clinic with NeuroSAFE had significantly lower odds on PSM (odds ratio [OR]: 0.70, 95% confidence interval [CI]: 0.56-0.88; P = 0.002), PSM length >1 mm (OR: 0.14, 95% CI: 0.09-0.22; P < 0.001), and >3 mm (OR: 0.21, 95% CI: 0.14-0.30; P < 0.001). This study provides a detailed overview of surgical margin status in a centralized RP NeuroSAFE cohort. Centralization with NeuroSAFE was associated with lower PSM rates and significantly shorter PSM cumulative lengths, indicating improved control of surgical margin status.

Effects of Bony Pelvic and Prostate Dimensions on Surgical Difficulty of Robot-Assisted Radical Prostatectomy: An Original Study and Meta-analysis.

Due to the deep location of the prostate within the pelvic cavity, procedures of robot-assisted radical prostatectomy (RARP) might be challenged by the prostate size and the limited pelvic cavity space. This study aimed to investigate the roles of bony pelvic and prostate dimensions in RARP procedures by an original study coupled with a meta-analysis. In the original study, patients undergoing multiport RARP between 2021 and 2022 were consecutively assessed. The associations of anatomic features with operative time (OT), estimated blood loss (EBL), and positive surgical margin (PSM) were evaluated using linear and logistic regression analyses as well as restricted cubic spline (RCS) analysis. Based on machine-learning algorithms, this study established predictive models for surgical difficulty and interpreted the model using SHapley Additive exPlanation (SHAP). In the meta-analysis, three databases were searched for eligible studies. Quantitative syntheses were subsequently performed. Overall, 219 patients were enrolled in the original study. Prostate volume (PV) and the prostate volume-to-pelvic cavity index (PCI) ratio (PV-to-PCI ratio) were significantly associated with longer OT (P < 0.05). In the RCS models, U-shaped associations were observed between the prostate anteroposterior diameter (PAD) and OT, and between the prostate height (PH) and EBL, and an L-shaped association was observed between the anteroposterior diameter of the pelvic inlet (API) and EBL. The XGBoost model was superior to the logistic regression model in predicting prolonged OT. The meta-analysis demonstrated that greater PV was significantly associated with longer OT (β = 0.20; 95% confidence interval [CI] 0.12-0.27; odds ratio [OR] = 1.05; 95% CI 1.00-1.11), and a smaller PV could increase the risk of PSM (OR = 0.82; 95% CI 0.77-0.88). A large prostate within a narrow and deep pelvis might suggest increased surgical difficulty of RARP. The size of the pelvic inlet also had a great impact on RARP. For PAD and PH, there seemed to be an optimal range with the lowest surgical difficulty. Machine-learning models based on the XGBoost algorithm could be successfully applied to predict the surgical difficulty of RARP.

Lateral versus anterior approach for bladder neck dissection during robot-assisted radical prostatectomy: a pair-matched analysis to evaluate urinary continence and surgical margins

Introduction The preservation of the bladder neck during robot-assisted radical prostatectomy (RARP) could improve urinary continence recovery and limit the risk of positive surgical margins (PSMs). We refined our lateral approach to the bladder neck technique and compared its outcomes with those of the standard anterior approach. Material and methods From a retrospective analysis of 599 consecutive RARPs, 171 patients treated with the lateral and 171 patients treated with the anterior approach were pair-matched 1:1 on the basis of age, grade, and pathological stage. We described our surgical technique and compared the two approaches in terms of basal PSMs, recovery of urinary continence, and complications. Results As compared to the anterior approach, the lateral approach had shorter operative times and comparable rates of basal PSMs and postoperative complications. The rates of urinary continence after one, three, and 12 months were comparable between the two groups and were generally higher in localized disease. At regression analysis, predictors of urinary incontinence were only age, pathological stage T3b, ISUP grade 5 and nerve-sparing surgery. Conclusions The lateral approach leads to an anatomical dissection of the bladder neck without increasing the risk of PSMs. However, no significant benefits in terms of continence recovery were demonstrated over the standard anterior approach.

Analysis of factors associated with positive surgical margins and the five-year survival rate after prostate cancer resection and predictive modeling.

This study analyzed the risk factors associated with positive surgical margins (PSM) and five-year survival after prostate cancer resection to construct a positive margin prediction model. We retrospectively analyzed the clinical data of 148 patients treated with prostatectomy. The patients were divided into PSM group and Negative surgical margins (NSM) group. Several parameters were compared between the groups. All patients were followed up for 60 months. The risk factors for PSM and five-year survival were evaluated by univariate analysis, followed by multifactorial dichotomous logistic regression analysis. Finally, ROC curves were plotted for the risk factors to establish a predictive model for PSM after prostate cancer resection. (1) Serum PSA, percentage of positive puncture stitches, clinical stage, surgical approach, Gleason score on puncture biopsy, and perineural invasion were significantly associated with the risk of PSM (P < 0.05). Serum PSA, perineural invasion, Gleason score on puncture biopsy, and percentage of positive puncture stitches were independent risk factors for PSM. (2) Total prostate-specific antigen (tPSA) by puncture, nutritional status, lymph node metastasis, bone metastasis, and seminal vesicle invasion may be risk factors for five-year survival. Lymph node metastasis and nutritional status were the main risk factors for the five-year survival of patients with prostate cancer. (3) After plotting the ROC curve, the area under the curve (AUC) [AUC: 0.776, 95%, confidence interval (CI): 0.725 to 0.854] was found to be a valid predictor of PSM; the AUC [AUC: 0.664, 95%, confidence interval (CI): 0.576 to 0.753] was also a valid predictor of five-year survival (P < 0.05). (4) The scoring system had a standard error of 0.02 and a cut-off value of 6. It predicted PSM after prostate cancer resection with moderate efficacy. Serum PSA, perineural invasion, puncture biopsy Gleason score, and percentage of positive puncture stitches were independent risk factors for positive surgical margins (PSM). Also, lymph node metastasis and nutritional status were the main risk factors for the five-year survival of patients with prostate cancer. Overall, the prediction efficacy of this scoring system concerning the risk of PSM after prostate cancer resection was moderate.

Delay in Cutaneous Squamous Cell Carcinoma Diagnosis Due to Interrupted Services Is Associated with Worse Prognoses and Modified Surgical Approaches.

The delayed diagnosis of skin tumors is associated with a worsened prognosis. The impact of the interruption of clinical and surgical health services during the COVID-19 pandemic lockdowns has been documented among many pathologies. The impact of delayed diagnoses on patients with cutaneous squamous cell carcinomas (cSCCs) is poorly defined. To compare patient and lesion characteristics and the surgical management of excised cSCCs prior to the pandemic shutdown of services (2018-2019) with the phase following the pandemic's second wave (2021-2022). An observational, single-center, cross-sectional study of 416 surgically excised cSCCs over the course of two years was performed. Only patients with histologically confirmed cSCC were enrolled. Data collection included patient demographics and lesion characteristics, time to surgery, surgical approach, and histological data. More cSCC lesions were excised prior to the interruption of services (n = 312 vs. n = 186). Lesions were significantly larger (1.7 ± 1.2 vs. 2.1 ± 1.5 cm; p = 0.006) and more invasive (52% vs. 89%; p < 0.001), in the period 2021-2022. Surgical reconstructive techniques were significantly different (p = 0.001). Metastatic involvement was confirmed in three subjects (one in 2018-2019 and two in 2021-2022). There were no significant differences in the time to surgery or patient characteristics. Multivariable regression analysis identified a 4.7-times higher risk of tumor invasion (OR 4.69, 95%CI 2.55-8.16, p < 0.001), a two-times higher chance of dermo-epidermal grafts (OR 2.06, 95%CI 1.09-3.88, p = 0.025), and a 3.2-times higher risk of positive surgical margins (OR 3.21, 95%CI 1.44-7.17, p = 0.004). Diagnostic delays of cutaneous SCCs associated with reduced patient access to clinical and diagnostic services are associated with a 4.7-times increased risk of more severe invasion, a three-times increased risk of positive surgical margins, and a significant impact on surgical management, compared to the pre-pandemic period. Comparable patient cohort characteristics and time to surgery remained unchanged.

The Prognostic Impact of the Surgical Margin in Renal Cell Carcinoma Treated with Partial Nephrectomy: A Multi-Center Study.

Background: Partial nephrectomy (PN) is the preferred treatment for small, localized kidney tumors. Incomplete resection resulting in positive surgical margins (PSM) can occur after PN. The impact of PSM on the risk of recurrence and survival outcomes is not fully understood. We aimed to explore the relationship between PSM, the risk of recurrence and impact on survival after PN in a large multicenter cohort from Denmark. Methods: This was a retrospective cohort study including patients who underwent PN for renal cell carcinoma (RCC) at three departments in Denmark between 2010 and 2016. Data including pathological features, surgical techniques, and patient follow-up was retrieved from electronic medical health records and national databases. We used a combination of descriptive statistics, comparative analysis (comparisons were carried out by Mann-Whitney Test, independent Student's t-test, or Pearson's chi-Square Test), univariate and multivariate logistic regression analyses, and survival analysis methods. Results: A total of 523 patients were included, of which 48 (9.1%) had a PSM. Recurrence was observed in 55 patients (10.5%). Median follow-up time was 75 months. We found a lower incidence of PSM with robot-assisted PN (p = 0.01) compared to open or laparoscopic PN. PSM was associated with a higher risk of recurrence compared to negative margins in univariate analysis, but not multivariate analysis. However, the study was underpowered to describe this association with other risk factors. Overall survival did not differ between patients with PSM and negative margins. Conclusions: Our study presents further evidence on the negative impact of PSM on recurrence after PN for RCC, highlighting the importance of achieving NSM, thus potentially improving clinical outcomes. A surgical approach was found to be the only predictive factor influencing the risk of PSMs, with a reduced risk observed with robot-assisted laparoscopy.

Clinical risk prediction model and external validation of positive surgical margin in laparoscopic radical prostatectomy based on MRI lesion location.

To clarify the composition of lesions in different magnetic resonance imaging (MRI) partitions of positive surgical margins (PSM) after laparoscopic radical prostatectomy, explore the influence of lesion location on PSM, and construct a clinical prediction model to predict the risk of PSM. This retrospective cohort study included 309 patients who underwent laparoscopic radical prostatectomy from 2018 to 2021 in our center was performed. 129 patients who met the same criteria from January to September 2022 were external validation cohorts. The incidence of PSM in transition zone (TZ) lesions was higher than that in peripheral zone (PZ) lesions. The incidence of PSM in the middle PZ was lower than that in other regions. Prostate specific antigen (PSA), clinical T-stage, the number of positive cores, international society of urological pathology (ISUP) grade (biopsy), MRI lesion location, extracapsular extension, seminal vesicle invasion (SVI), pseudo-capsule invasion (PCI), long diameter of lesions, lesion volume, lesion volume ratio, PSA density were related to PSM. MRI lesion location and PCI were independent risk factors for PSM. Least absolute shrinkage and selection operator (LASSO) regression was used to construct a clinical prediction model for PSM, including five variables: the number of positive cores, SVI, MRI lesion location, long diameter of lesions, and PSA. The positive rate of surgical margin in middle PZ was significantly lower than that in other regions, and MRI lesion location was an independent risk factor for PSM.

Predictive Factors for Extracapsular Extension of Prostate Cancer to Select the Candidates for Nerve-sparing Radical Prostatectomy.

Nerve-sparing radical prostatectomy (NSRP) for prostate cancer (PC) enables better postoperative recovery of continence and potency but may increase the risk of positive surgical margins. This study aimed to investigate preoperative predictive factors for extracapsular extension (ECE) of PC to select patients for NSRP. We retrospectively evaluated 288 patients with PC (576 lobes) diagnosed with 12-core transrectal ultrasound-guided biopsy and magnetic resonance imaging (MRI) who underwent laparoscopic or robot-assisted radical prostatectomy at our institution. Surgical specimens and preoperative parameters (prostate-specific antigen, prostate volume, biopsy and MRI findings, preoperative therapy) were analyzed. Of 576 prostate lobes, the incidence Ipsilateral ECE was identified in 97 (16.8%) lobes. The higher number of unilateral positive biopsy cores, the highest Gleason score 8 or more and positive unilateral findings on MRI are significant higher in prostate sides with ECE in univariate analysis. In multivariate analysis, positive unilateral MRI findings (odds ratio [OR], 2.86; p < 0.001) and unilateral biopsy positive core ≥ 3 (OR, 3.73; p < 0.001) were independent predictors of unilateral ECE. The detection rate of unilateral ECE in those cases with two factors (side-specific positive biopsy core 2 or less and side-specific MRI findings negative) was 7.1% (19/269). Patients with fewer unilateral positive biopsy cores and negative unilateral MRI findings might be good candidates for NSRP.

Less qualitative multiparametric magnetic resonance imaging in prostate cancer can underestimate extraprostatic extension in higher grade tumors.

Multiparametric magnetic resonance imaging (mpMRI) is increasingly used for risk stratification and preoperative staging of prostate cancer. It remains unclear how Grade Group (GG) interacts with the ability of mpMRI to determine the presence of extraprostatic extension (EPE) on surgical pathology. A retrospective review of a robotic assisted laparoscopic radical prostatectomy (RALP) database from 2016-2020 was performed. Radiology mpMRI reports by multiple attending radiologists and without clear standardization or quality control were retrospectively assessed for EPE findings and compared with surgical pathology reports. The data were stratified by biopsy-based GG and a multivariable cluster analysis was performed to incorporate additional preoperative variables (age at diagnosis, PSA, etc.). Hazard ratios were calculated to determine how mpMRI findings and radiographic EPE relate to positive surgical margins. 289 patients underwent at least one mpMRI prior to RALP. Preoperative mpMRI demonstrated sensitivity of 39.3% and specificity of 88.8% for pathological EPE and had a negative predictive value (NPV) of 49.5%, and positive predictive value (PPV) of 84.0%. Stratification of NPV by GG yielded the following values: GG 1-5 (49.5%), GG 3-5 (40.8%), GG 4-5 (43.4%), and GG 5 (30.4%). Additionally, positive EPE on preoperative mpMRI was associated with a significantly decreased risk of positive surgical margins (RR: 0.655; 95% CI: 0.557-0.771). NPV of prostate mpMRI for EPE may be decreased for higher grade tumors. A detailed reference reading and image quality optimization may improve performance. However, urologists should exercise caution in nerve sparing approaches in these patients.

Retzius-Sparing Robotic-Assisted Prostatectomy: Technical Challenges for Surgeons and Key Prospective Refinements.

Robotic-assisted radical prostatectomy (RARP) is the gold standard for localized prostate cancer. Several RARP approaches were developed and described over the years, aimed at improving oncological and functional outcomes. In 2010, Galfano et al described a new RARP technique, known as Retzius-sparing RARP (RS-RARP), a posterior approach through the Douglas space that spares the anterior support structures involved with urinary continence and sexual potency. This approach has been used increasingly in many centers around the world comparing its results with those of the most used standard anterior approach. Several randomized controlled trials, systematic reviews and meta-analyses demonstrated an important advantage relative to standard anterior RARP in terms of early urinary continence recovery, with comparable perioperative and long-term oncological outcomes. Several surgeons are concerned regarding RS-RARP because it appears to increase the risk of positive surgical margins (PSMs). However, this statement is based on low-certainty evidence. Indeed, the available studies compared the results of surgeons who had an initial experience with posterior RARP with those who had a solid experience with anterior RARP. Recent evidence strongly suggests that RS-RARP is feasible and safe not only in low- and intermediate-risk prostate cancer patient but also in challenging scenario such as high-risk setting, salvage prostatectomy and after transurethral resection of the prostate.

Positive Surgical Margins After Anterior Robot-assisted Radical Prostatectomy: Assessing the Learning Curve in a Multi-institutional Collaboration

BackgroundThe learning curve for robot-assisted radical prostatectomy (RARP) remains controversial, with prior studies showing that, in contrast with evidence on open and laparoscopic radical prostatectomy, biochemical recurrence rates of experienced versus inexperienced surgeons did not differ. ObjectiveTo characterize the learning curve for positive surgical margins (PSMs) after RARP. Design, setting, and participantsWe analyzed the data of 13 090 patients with prostate cancer undergoing RARP by one of 74 surgeons from ten institutions in Europe and North America between 2003 and 2022. Outcome measurements and statistical analysisMultivariable models were used to assess the association between surgeon experience at the time of each patient’s operation and PSMs after surgery, with adjustment for preoperative prostate-specific antigen level, grade, stage, and year of surgery. Surgeon experience was coded as the number of robotic radical prostatectomies done by the surgeon before the index patient’s operation. Results and limitationsOverall, 2838 (22%) men had PSMs on final pathology. After adjusting for case mix, we found a significant, nonlinear association between surgical experience and probability of PSMs after surgery, with a lower risk of PSMs for greater surgeon experience (p < 0.0001). The probabilities of PSMs for a patient treated by a surgeon with ten, 250, 500, and 2000 prior robotic procedures were 26%, 21%, 18%, and 14%, respectively (absolute risk difference between ten and 2000 procedures: 11%; 95% confidence interval: 9%, 14%). Similar results were found after stratifying patients according to extracapsular extension at final pathology. Results were also unaltered after excluding surgeons who had moved between institutions. ConclusionsWhile we characterized the learning curve for PSMs after RARP, the relative contribution of surgical learning to the achievement of optimal outcomes remains controversial. Future investigations should focus on what experienced surgeons do to avoid positive margins and should explore the relationship between learning, margin rate, and biochemical recurrence. Understanding what margins affect recurrence and whether these margins are trainable or a result of other factors may shed light on where to focus future efforts in surgical education. Patient summaryIn patients receiving robotic radical prostatectomy for prostate cancer, we characterized the learning curve for positive margins. The risk of surgical margins decreased progressively with increasing experience, and plateaued around the 500th procedure. Understanding what margins affect recurrence and whether these margins are trainable or a result of other factors has implications for surgeons and patients, and it may shed light on where to focus future efforts in surgical education.

Perioperative NALIRIFOX in patients with resectable pancreatic ductal adenocarcinoma: The open-label, multicenter, phase II nITRO trial

BackgroundUpfront surgery followed by postoperative treatment is a commonly adopted treatment for resectable pancreatic ductal adenocarcinoma (rPDAC). However, the risk of positive surgical margins, the poor recovery that often impairs postoperative treatments, and the risk of recurrence might limit the outcome of this strategy. This study evaluated the safety and the activity of liposomal irinotecan 50 mg/m2 + 5-fluorouracil 2400 mg/m2 + leucovorin 400 mg/m2 + oxaliplatin 60 mg/m2 (NALIRIFOX) in the perioperative treatment of patients with rPDAC. MethodsEligible patients had a rPDAC with < 180° interface with major veins’ wall. Patients received 3 cycles before and 3 cycles after resection with NALIRIFOX, days 1 and 15 of a 28-day cycle. The primary endpoint was the proportion of patients undergoing an R0 resection. Results107 patients began preoperative treatment. Nine patients discontinued the treatment because of related or unrelated adverse events. Disease-control rate was 92.9%. 87 patients underwent surgical exploration, 11 had intraoperative evidence of metastatic disease, and 1 died for surgical complications. R0 resection rate was 65.3%. 49 patients completed the three postoperative cycles. The most common grade ≥ 3 adverse events were diarrhea and neutropenia. Median overall survival (OS) of ITT patients was 32.3 months (95% CI 27.8–44.3). Median disease-free and OS from surgery of resected patients were 19.3 (95% CI 12.6–34.1) and 40.3 months (95% CI 29-NA), respectively. ConclusionPerioperative NALIRIFOX was manageable and active, and deserves further investigation in randomized trials comparing it with standard upfront surgery followed by adjuvant therapy.

An MRI-based grading system for preoperative risk estimation of positive surgical margin after radical prostatectomy

ObjectiveTo construct a simplified grading system based on MRI features to predict positive surgical margin (PSM) after radical prostatectomy (RP).MethodsPatients who had undergone prostate MRI followed by RP between January 2017 and January 2021 were retrospectively enrolled as the derivation group, and those between February 2021 and November 2022 were enrolled as the validation group. One radiologist evaluated tumor-related MRI features, including the capsule contact length (CCL) of lesions, frank extraprostatic extension (EPE), apex abutting, etc. Binary logistic regression and decision tree analysis were used to select risk features for PSM. The area under the curve (AUC), sensitivity, and specificity of different systems were calculated. The interreader agreement of the scoring systems was evaluated using the kappa statistic.ResultsThere were 29.8% (42/141) and 36.4% (32/88) of patients who had PSM in the derivation and validation cohorts, respectively. The first grading system was proposed (mrPSM1) using two imaging features, namely, CCL ≥ 20 mm and apex abutting, and then updated by adding frank EPE (mrPSM2). In the derivation group, the AUC was 0.705 for mrPSM1 and 0.713 for mrPSM2. In the validation group, our grading systems showed comparable AUC with Park et al.’s model (0.672–0.686 vs. 0.646, p > 0.05) and significantly higher specificity (0.732–0.750 vs. 0.411, p < 0.001). The kappa value was 0.764 for mrPSM1 and 0.776 for mrPSM2. Decision curve analysis showed a higher net benefit for mrPSM2.ConclusionThe proposed grading systems based on MRI could benefit the risk stratification of PSM and are easily interpretable.Critical relevance statementThe proposed mrPSM grading systems for preoperative prediction of surgical margin status after radical prostatectomy are simplified compared to a previous model and show high specificity for identifying the risk of positive surgical margin, which might benefit the management of prostate cancer.Key points• CCL ≥ 20 mm, apex abutting, and EPE were important MRI features for PSM.• Our proposed MRI-based grading systems showed the possibility to predict PSM with high specificity.• The MRI-based grading systems might facilitate a structured risk evaluation of PSM.Graphical

Can pelvic diameter measurement have an effect on surgical outcomes in radical cystectomy?

ObjectiveTo determine the effectiveness of pelvis diameters in determining postoperative outcomes in men who underwent open radical cystectomy + urinary diversion, it is aimed to predict the factors that may affect the operative difficulty and possible surgical outcomes before the operation.MethodsA total of 79 radical cystectomy patients operated in our institution with preoperative computed tomography (CT) were included the study. Pelvic dimensions; symphysis angle (SA), upper conjugate, lower conjugate, pelvic depth, apical depth (AD), interspinous distance (ISD), bone femoral width and soft tissue width were measured by preoperative CT. ISD index were defined as ISD/AD. Postoperative outcomes and indicators of operative difficulty were recorded. Regression analyses were used to predict perioperative and postoperative outcomes.ResultsTotal of 96 complications were observed in 52 of the 79 patients in ninety days (65,8%) with a mean age of 68.25 years. There were significant correlations between SA and body mass index (BMI) with operative time (p = 0.006, p < 0.001; respectively). For estimated blood loss, there were significant correlations between preoperative hematocrit (p = 0,031). Analysis of multivariate logistic regression revealed that higher Charlson comorbidity index (CCI) and BMI were found to be significant predictors for major complications while CCI, pathological T stage and ISD index are prominent predictors for surgical margin positivity.ConclusionsPelvic dimensions are not significant with minor or major complications. However, operative time may be associated with SA. Also, narrow and deep pelvis may increase the risk of positive surgical margins.

Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial

BackgroundPelvic fascia-sparing robotic-assisted radical prostatectomy (PFS-RARP) is a novel approach that spares the endopelvic fascia ventral to the prostate. The preservation of more native structures compared to conventional robotic-assisted radical prostatectomy (RARP) may lead to faster recovery of urinary function, fewer penile changes, and decreased inguinal hernia sequelae, but may have a higher risk for positive surgical margins and poorer cancer control. However, high-level evidence is absent. The PARTIAL trial is a surgical randomized controlled trial (RCT) aiming to bridge this evidence gap (NCT05155501). MethodsWe describe a prospective RCT with a projected enrollment of 600 men randomized to PFS-RARP vs. RARP. The primary outcome is cancer control (positive surgical margins and prostate-specific antigen failure) and secondary outcomes include health-related quality of life pertaining to urinary and sexual function, decision regret, and adverse events (30-day complications, inguinal hernias, penile shortening, and Peyronie's disease). The anticipated duration of trial participation is 24 months. Study participation is incentivized with the use of innovative methodologies such as a novel, two-stage informed consent and a validated web-based interface to monitor patient-reported symptoms and empower individuals to improve their recovery. ConclusionIf PFS-RARP is non-inferior to RARP in terms of cancer control and has better functional outcomes, it should be the surgical standard of care for men with localized prostate cancer. Using the innovative two-stage consent process, completion of the trial will not only provide much needed evidence on one of the most common cancer surgeries but also insight on improving surgical RCT methodology.Trial statusThis trial is registered at ClinicalTrials.gov (NCT05155501; first posted on December 13, 2021); Institutional approval number: WCM IRB # 21-07023781, BRANY's initial approval event ID # 186333. The trial is not yet recruiting.

MP80-01 THE SURGICAL LEARNING CURVE FOR POSITIVE SURGICAL MARGINS AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY: RESULTS FROM A MULTI-INSTITUTIONAL COLLABORATION

MP80-01 THE SURGICAL LEARNING CURVE FOR POSITIVE SURGICAL MARGINS AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY: RESULTS FROM A MULTI-INSTITUTIONAL COLLABORATION

Predictors and outcomes of positive surgical margins after local excision of clinical T1 rectal cancer: A National Cancer Database analysis

BackgroundTransanal local excision and the use of specialized platforms has become increasingly popular for early-stage rectal cancer. Predictors and outcomes of positive resection margins following transanal local excision for early-stage rectal cancer have yet to be explored. MethodsThis was a retrospective analysis of the National Cancer Database of all patients with clinical nonmetastatic node negative T1 rectal adenocarcinoma who underwent transanal local excision from 2004 to 2017. Patients with positive surgical margins were compared to those with negative resection margins to determine factors associated with predictors and outcomes of positive surgical margins after transanal local excision. The main outcome measure was overall survival. ResultsOf 318,548 patients with rectal adenocarcinoma in the National Cancer Database, 9,078 (2.8%) met the inclusion criteria. The positive surgical margins rate was 7.4%. Predictors of positive surgical margins were older age (odds ratio, 1.03; P < .001), higher Charlson comorbidity index (odds ratio, 1.24; P = .004), poorly differentiated carcinomas (odds ratio, 1.89; P < .001), mucinous (odds ratio, 2.36; P = .003) and signet-ring cell carcinomas (odds ratio, 4.7; P = .048). Independent predictors of reduced survival were older age (hazard ratio, 1.062; P < .001), male sex (hazard ratio, 1.214; P = .011), Charlson comorbidity index 3 (hazard ratio, 1.94; P < .001), pathologic T2 (hazard ratio, 1.27; P = .036) and T3 stages (hazard ratio, 1.77; P = .006), poorly differentiated carcinomas (hazard ratio, 1.47; P = .008), and positive surgical margins (hazard ratio, 1.374; P = .018). The positive surgical margins group's median overall survival was significantly shorter (88 vs 159.3 months, P < .001). ConclusionPositive surgical margins after transanal local excision for early-stage node-negative rectal cancer adversely affects prognosis. Older male patients with higher Charlson comorbidity index scores and poorly differentiated mucinous or signet cell histology tumors are at risk for positive surgical margins. Patient selection according to these suggested criteria may help avoid positive surgical margins.

NITRO: A phase 2 study of perioperative liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) in patients with resectable pancreatic ductal adenocarcinoma (rPDAC).

701 Background: Upfront surgery followed by adjuvant therapy is the standard treatment for patients with rPDAC. However, the risk of positive surgical margins, the poor recovery after surgery that often impairs postoperative treatment, and the high risk of relapse might limit the overall outcome of this strategy. This trial assessed the safety and the activity of liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2 (NALIRIFOX) in the perioperative treatment of patients with rPDAC. Methods: nITRO is an investigator-initiated, Simon’s two-stages, single arm phase 2 study. Eligible patients had newly diagnosed rPDAC with &lt;180° interface with major veins’ wall and a Karnofsky status ≥60. Patients received a perioperative treatment of 3 cycles before and 3 cycles after resection with NALIRIFOX, d1 and 15 of a 28 days cycle. The primary endpoint was the proportion of patients undergoing an R0 resection. Results: Between April 2018 and May 2022, 168 patients were referred by surgical units as potentially eligible for upfront resection. These patients were prescreened by CT and MRI scans within 4 weeks before treatment and 60 showed a rapid progression to a locally advanced or metastatic disease. One was not eligible because of heart failure. Among 107 patients who were enrolled and began preoperative treatment, 86 (80.4%) received all the 3 planned preoperative cycles. One patient (0.9%) obtained a radiological complete response, 22 (20.6%) a partial response, and 68 (63.6%) a stable disease, accounting for a disease control rate of 85.0%. Nine patients discontinued because of treatment related or unrelated adverse events. Seven patients had a radiological, and 2 a clinical progression. Two patients were defined as not resectable at surgical reevaluation. Most common adverse events of grade ≥3 during preoperative treatment included neutropenia (13.0%), diarrhea (9.4%) cholangitis (6.6%), mucositis (5.6%) and hypokaliemia (5.6%). One patient died for treatment-related neutropenia and sepsis. Thus, 87 (81.2%) patients underwent surgical exploration, 11 (12.6%) of them had intraoperative evidence of unresectable or metastatic disease, and 1 died for surgical complications. Among the 75 patients who underwent resection, 49 achieved an R0 resection accounting for a rate of 65.3%, largely exceeding the alternative hypothesis of 55%. Median disease-free and overall survival of resected patients were 31.3 (95% CI 17.0-45.6) and 44.9 months (95% CI 33.1-56.8), respectively. Conclusions: NALIRIFOX was manageable and active for patients with rPDAC. Perioperative NALIRIFOX allows to select those patients who may benefit from resection to the largest extent. Perioperative NALIRIFOX deserves further investigation in randomized trials comparing it with standard upfront surgery followed by adjuvant therapy. Clinical trial information: NCT03528785 .

Intra-operative fluorescence-based detection of positive surgical margins during radical prostatectomy: Lessons learned from a pilot ex vivo translational study.

Nerve-sparing techniques during radical prostatectomy have been associated with an increased risk of positive surgical margins. The intra-operative detection of residual prostatic tissue could help mitigate this risk. The objectives of the present study were to assess the feasibility of using an anti-prostate-specific membrane antigen (anti-PSMA) antibody conjugated with a fluorophore to characterize fresh prostate tissue as prostatic or non-prostatic for intra-operative surgical margin detection. Fresh prostatic tissue samples were collected from transurethral resections of the prostate (TURP) or prostate biopsies, and either immunolabelled with anti-PSMA antibody conjugated with Alexa Fluor 488or used as controls. A dedicated, laparoscopy-compliant fluorescence device was developed for real-time fluorescence detection. Confocal microscopy was used as the gold standard for comparison. Spectral unmixing was used to distinguish specific, Alexa Fluor 488 fluorescence from nonspecific autofluorescence. The average peak wavelength of the immuno-labeled TURP samples (n = 4) was 541.7 ± 0.9 nm and of the control samples (n = 4) was 540.8 ± 2.2 nm. Spectral unmixing revealed that these similar measures were explained by significant autofluorescence, linked to electrocautery. Three biopsy samples were then obtained from seven patients and also displayed significant nonspecific fluorescence, raising questions regarding the reproducibility of the fixation of the anti-PSMA antibodies on the samples. Comparing the fluorescence results with final pathology proved challenging due to the small sample size and tissue alterations. This study showed similar fluorescence of immuno-labeled prostate tissue samples and controls, failing to demonstrate the feasibility of intra-operative margin detection using PSMA immuno-labeling, due to marked tissue autofluorescence. We successfully developed a fluorescence device that could be used intraoperatively in a laparoscopic setting. Use of the infrared rangeas well as newly available antibodies could prove interesting options for future research.