Background:Cushing syndrome (CS) from metastatic adrenocortical carcinoma (ACC) or neuroendocrine tumors (NETs) presents a therapeutic challenge when surgery is not feasible. Liver-directed embolization, including bland transarterial embolization (TAE) and yttrium-90 (Y-90) radioembolization, may palliate hypercortisolism arising from hormonally active hepatic metastases. Methods:We conducted a retrospective single-center case series of 4 adult patients (≥18 years) with CS and liver-dominant metastatic ACC or NET who underwent hepatic embolization between 2015 and 2025. Inclusion criteria were: (1) confirmed CS based on standard biochemical testing, and (2) receipt of liver-directed embolization (TAE or Y-90) for hypercortisolism. Exclusion criteria were absence of pre- and postembolization hormonal data preventing biochemical assessment. The primary outcome was biochemical response within 14 days (≥50% reduction or normalization of morning cortisol). Secondary outcomes included duration of biochemical control, radiographic response (RECIST 1.1), and adverse events (CTCAE v5.0). Results:Four patients (2 ACC, 2 NET) underwent Y-90 (n = 1) or TAE (n = 3). All achieved significant cortisol; 2/4 normalized cortisol with transient adrenal insufficiency. The Y-90 patient had sustained remission, while 2 TAE patients achieved partial hormonal control enabling tapering of medical therapy. Radiographically, tumor burden stabilized or improved in most treated lesions. Embolization was well tolerated, with only 1 case of post-embolization syndrome and no procedure-related mortality. One patient died from disease progression; 3 remain alive with controlled or improving disease. Conclusion:Hepatic embolization is a viable palliative option for CS due to unresectable liver-dominant metastases, providing meaningful biochemical improvement with acceptable safety and supporting integration into multidisciplinary CS management.
BACKGROUND:Large pancreatic cystic lesions (PCLs) have a higher risk of malignant transformation compared with smaller PCLs, although the biological basis for this remains unclear. We aimed to study the high-risk mutation (HRM) patterns in large vs small PCLs using cyst fluid next-generation sequencing (NGS) analysis. STUDY DESIGN:This is a large multicenter study that included patients with PCLs who underwent pancreatic cyst fluid PancreaSeq NGS testing between January 2018 and February 2020. Patients without index cyst size data were excluded from this study. HRMs were defined as alterations in TP53 , SMAD4 , CTNNB1 , mTOR , and MEN1 genes. Patients were categorized into large PCLs (greater than or equal to 3 cm) and small PCLs (less than 3 cm) groups. Primary outcomes included rates of HRMs and the co-occurrence of multiple HRMs. Diagnostic performance of PancreaSeq NGS and guideline parameters for predicting advanced neoplasia was also assessed in patients with large intraductal papillary mucinous neoplasms (IPMNs). RESULTS:A total of 1,167 patients were included, with 404 having large PCLs. HRMs were identified in 175 patients (15%), with TP53 and SMAD4 mutations more frequently in large PCLs. Large PCLs showed significantly higher rates of any HRMs and co-occurrence of multiple HRMs. On multivariate analysis, cyst size greater than or equal to 3 cm was independently associated with HRMs (odds ratio 3.63, 95% CI 1.28 to 10.29). In large IPMNs, NGS detection of TP53 , SMAD4 , CTNNB1 , and/or mTOR alterations showed a sensitivity of 92.3% and specificity of 94.7% for predicting advanced neoplasia. CONCLUSIONS:The higher malignant potential of large PCLs may be explained by their greater propensity to harbor HRMs associated with advanced neoplasia. Given the superior diagnostic accuracy of NGS for predicting advanced neoplasia in large IPMNs, we recommend incorporating cyst fluid NGS into the management algorithm for patients with IPMNs greater than or equal to 3 cm.
Skill retention and decay are critical in robotic surgical simulation training. While performance decay has been studied in virtual reality platforms, its effects in high-fidelity biotissue drills remain underexplored. We evaluated both the impact of training breaks and the benefits of continued practice beyond proficiency among general surgery residents performing simulated robotic bowel anastomoses. This retrospective study analyzed 132 h of robotic simulation from 45 residents who reached proficiency (OSATS ≥ 28) on a high-fidelity bowel anastomosis drill. Two cohorts were included: a skill decay group (n = 30) who returned ≥ 1 month after achieving proficiency, and a continued training group (n = 15) who completed ≥ 3 additional sessions post-proficiency. OSATS scores and task times were compared between initial and follow-up sessions. Skill decay was defined as a ≥ 2-point OSATS drop or ≥ 6-min time increase. Statistical tests included paired comparisons, ROC analysis, and multivariable logistic regression. In the skill decay group, the median interval was 91 days (IQR 63–134). Task time increased from 30.5 to 34.5 min (p = 0.03), while OSATS declined from 30 to 28 (p = 0.001). By 6 months, OSATS scores dropped 17.6
Background Patients with social barriers have poor cancer outcomes. The combined relationship of cancer survival with guideline concordance, time to treatment, and social vulnerability has not been studied. Our objective was to determine whether optimal care is associated with survival and whether this relationship differs with social vulnerability. Methods Adult patients diagnosed with localized colon cancer, non-small-cell lung cancer (NSCLC), or pancreatic cancer from 2006 to 2016 and followed until 2021 were identified from California and Texas Cancer Registries and analyzed with the census-tract level Social Vulnerability Index. Optimal care (guideline-concordant treatment initiated within 60 days of diagnosis) was used to create an interaction variable by combining it with the Social Vulnerability Index. A multivariable Cox proportional hazards model was used for survival analysis. Results Of the 100,294 patients, 68.7% of those with colon cancer, 22.6% of those with pancreatic cancer, and 70.6% of those with NSCLC received optimal care. Cox models showed that patients who received optimal care had the lowest hazard ratios (HRs) for death compared with those who received least optimal care: colon cancer, HR 0.45 (95% confidence interval [CI] 0.36-0.57), NSCLC, HR 0.35 (95% CI 0.32-0.38), pancreatic cancer, HR 0.46 (95% CI 0.39-0.54). On interaction analysis, for patients with colon cancer or NSCLC who received optimal care, the risk of death was higher for patients who lived in the most vulnerable neighborhoods than for those who did not. Conclusion Care that is both guideline concordant and timely is associated with the highest overall survival for localized cancer. However, this association is reduced for patients with colon cancer or NSCLC residing in the most vulnerable neighborhoods.
OBJECTIVE:To evaluate the effect of cognitive training (CT) compared to standard non-cognitive training on surgical performance in robotic surgery. DESIGN:A systematic search of PubMed, Embase, ScienceDirect, and PsycINFO was conducted in accordance with PRISMA and Cochrane Handbook guidelines. Only randomized controlled trials (RCTs) were included. Risk of bias was assessed using the RoB 2 tool. SETTING:All studies took place in institutional training environments using simulation platforms. PARTICIPANTS:One hundred fifty four surgical trainees (medical students, residents, and fellows) were included. Of these, 78 participants (50.6%) received CT through mental rehearsal or computer-based training. RESULTS:Four randomized controlled trials (RCTs) were included. CT improved technical skills in 3 out of 4 studies. Reported benefits included a 52% reduction in tissue piercing (p < 0.001), superior knot-tying task performance (p = 0.01), and higher GEARS scores (CT group: mean of 13.1, SD 3.25; control group: mean of 11.4, SD 2.97; p = 0.03). NOTSS score showed no improvement (CT group: mean of 25.8, SD 7.34; control group: mean of 26.4, SD 9.13; p = 0.77). In contrast, an augmented mental rehearsal approach improved imagery and visuospatial ability (augmented CT group: mean of 20.1, SD 4.0; control group: mean of 14.6, SD 3.9; p = 0.02), whereas computer-based CT produced no improvement. CONCLUSIONS:CT, particularly mental rehearsal, may improve technical skills in robotic simulation among novice trainees. However, the certainty of this evidence is limited by small, heterogeneous studies, and all findings come from simulation settings. Finally, the impact of CT in more advanced learners and in real operating rooms remains uncertain.
Importance:Incidence of early age-onset colorectal cancer (EOCRC) is increasing. Delays in initiation of definitive therapy are associated with worse outcomes in colorectal cancer (CRC), but their impact on EOCRC has not been comprehensively characterized. Objective:To evaluate incidence of EOCRC, identify patients affected by treatment delays, and determine targetable factors contributing to delayed therapy. Design, Setting, and Participants:This retrospective, population-based cross-sectional study analyzed data from patients diagnosed with CRC from January 1, 2004, to December 31, 2019, using the Texas Cancer Registry. Patients were classified as having either EOCRC (diagnosed age <50 years) or average age-onset colorectal cancer (AOCRC; diagnosed age ≥50 years). The data analysis was performed between August 2024 and November 2025. Main Outcomes and Measures:The main outcomes were EOCRC status and treatment delays, defined as more than 6 weeks from tissue diagnosis to initiation of definitive therapy. Overall survival (OS), prevalence, impact of treatment delays, and patient-level and system-level factors associated with delayed treatment were also assessed. Results:Among 112 672 patients with CRC (overall mean [SD] age, 65.4 [13.5] years; 61 570 [54.6%] male), 12 079 (11%) had EOCRC, and 100 593 (89%) had AOCRC. The cohort comprised 3111 Asian and Pacific Islander individuals (2.8%), 14 517 Black individuals (12.9%), 23 372 Hispanic individuals (20.7%), and 71 672 White individuals (63.6%). Mean (SD) age for the EOCRC cohort was younger (41.6 [5.9] years) compared to the AOCRC cohort (68.2 [11.2] years; P < .001). Compared to patients with AOCRC, patients with EOCRC were less likely to be of White race (6421 [53.2%] vs 65 251 [64.9%]; P < .001) and more likely to be of Hispanic ethnicity (3389 [28.1%] vs 19 983 [19.9%]; P < .001). Median OS for patients with EOCRC was not reached compared to patients with AOCRC at 80 months (hazard ratio [HR], 0.56; 95% CI, 0.56-0.60; P < .001). In multivariable analysis, higher Social Vulnerability Index (HR, 1.22; 95% CI, 1.19-1.26; P < .001) and treatment delays (HR, 1.29; 95% CI, 1.26-1.32; P < .001) were associated with worse OS. Median OS for patients with EOCRC was not reached in patients with or without treatment delay; however, it remained significant (HR, 1.35; 95% CI, 1.32-1.38; P < .001). After controlling for demographic and clinical factors, language barriers were associated with treatment delay in EOCRC (odds ratio, 1.45; 95% CI, 1.18-1.79; P < .001). Conclusions and Relevance:In this cross-sectional study, EOCRC was associated with improved OS compared with AOCRC; however, treatment delays were independently associated with worse survival among patients with EOCRC. Language barriers could be a potentially modifiable risk factor associated with delayed treatment and may provide an opportunity to improve timely care and outcomes in EOCRC.
Abstract Background and Objectives The distinction between benign and neoplastic bile duct strictures remains challenging. Pathologic assessment of ERCP-obtained specimens has limited sensitivity, particularly among patients with primary sclerosing cholangitis (PSC). Next-generation sequencing (NGS) of bile duct specimens provides a promising diagnostic approach; but a prospective, multi-institutional, and comprehensive DNA/RNA analysis is lacking. Method A 6-year, prospective, multi-institutional study was conducted using BiliSeqV2 (28 cancer-associated genes and 167 fusion genes) and BiliSeqV3 (161 cancer-associated genes and 763 fusion genes) for 2908 ERCP-obtained brushings, biopsies, and bile from 2116 patients at 28 medical institutions across the United States. Molecular results were compared to clinical, imaging, and pathologic parameters including diagnostic pathology and/or at least 1-year follow-up. Results BiliSeqV2N3 testing was performed for 2865 (99%) specimens from 2080 (98%) patients. Based on follow-up from 1979 (95%) patients, BiliSeqV2N3 demonstrated 82% sensitivity and 98% specificity for a neoplastic stricture. In comparison, pathologic assessment had a sensitivity of 44% and a specificity of 99%. Combining BiliSeqV2N3 testing with pathologic assessment improved the sensitivity to 88% and maintained a high specificity of 97%. High-risk populations, such as Hispanic, germline carrier, and PSC patients, also showed improvement in sensitivity with BiliSeqV2N3 (74% to 86%) compared to pathologic assessment (26% to 50%). Further, actionable molecular alterations were identified in 20% of BiliSeqV3-positive neoplasms and modified patient management in 30% of these cases. Conclusions Applying BiliSeqV2N3 testing to ERCP-obtained specimens improved the diagnostic evaluation of bile duct strictures, achieving higher sensitivity, especially for PSC, and maintained high specificity compared to traditional methods. This study highlights the importance of NGS for precise diagnosis and therapeutic intervention.
BACKGROUND & AIMS:The distinction between benign and neoplastic bile duct strictures remains challenging. Pathologic assessment of endoscopic retrograde cholangiopancreatography (ERCP)-obtained specimens has limited sensitivity, particularly among patients with primary sclerosing cholangitis (PSC). Next-generation sequencing of bile duct specimens provides a promising diagnostic approach, but a prospective, multi-institutional, and comprehensive DNA/RNA analysis is lacking. METHODS:A 6-year, prospective, multi-institutional study was conducted using BiliSeq version 2 (28 cancer-associated genes and 167 fusion genes) and BiliSeq version 3 (161 cancer-associated genes and 763 fusion genes) for 2908 ERCP-obtained brushings, biopsies, and bile from 2116 patients at 28 medical institutions. Molecular results were compared with clinical, imaging, and pathologic parameters including diagnostic pathology and/or at least 1-year follow-up. RESULTS:BiliSeqV2/V3 testing was performed for 2865 (99%) specimens from 2080 (98%) patients. Based on follow-up from 1979 (95%) patients, BiliSeq version 2/version 3 demonstrated 82% sensitivity and 98% specificity for a neoplastic stricture. In comparison, pathologic assessment had a sensitivity of 44% and a specificity of 99%. Combining BiliSeq version 2/version 3 testing with pathologic assessment improved the sensitivity to 88% and maintained a high specificity of 97%. High-risk populations, such as Hispanic, germline carrier, and PSC patients, also showed improvement in sensitivity with BiliSeq version 2/version 3 (74% to 86%) compared with pathologic assessment (26% to 50%). Further, actionable molecular alterations were identified in 20% of BiliSeq version 3-positive neoplasms and modified patient management in 30% of these cases. CONCLUSIONS:Applying BiliSeq version 2/version V3 testing to ERCP-obtained specimens improved the diagnostic evaluation of bile duct strictures, achieving higher sensitivity, especially for PSC, and maintained high specificity compared with traditional methods. This study highlights the importance of next-generation sequencing for precise diagnosis and therapeutic intervention.
Objective: To determine the incidence of post-pancreatectomy hemorrhage (PPH) following robotic pancreatoduodenectomy (RPD) at high-volume US centers with experienced surgeons, and identify risk factors. Summary Background Data: Recent randomized trials report variable PPH rates following RPD. As RPD utilization increases, understanding PPH risk is critical. Methods: A retrospective cohort study across four high-volume robotic pancreas programs from 2007 to 2024, including all patients who underwent open pancreatoduodenectomy (OPD) or RPD. Primary outcome was PPH. Secondary outcomes included post-operative complications, length of stay, readmissions, 30- and 90-day mortality. Univariable and multivariable analysis (MVA) identified factors associated with PPH, post-operative pancreatic fistula (POPF), and mortality. Results: Among 1925 patients (61.1% OPD, 38.9% RPD), OPD patients had lower BMI ( P =0.0004) and larger tumors ( P =0.0029). The RPD conversion rate was 8.8%. Despite a higher proportion of soft glands (38.9% vs. 33.1%, P <0.0001), RPD had less POPF (4.8% vs 9.3%, P =0.0003). OPD had worse post-operative outcomes but no difference in mortality. Rate, location, and severity of PPH did not differ by approach. On MVA, RPD was associated with decreased POPF risk (OR 0.44, P <0.0001), but increased PPH risk (OR 1.63, P =0.017). POPF was associated with increased PPH risk (OR 3.97, P <0.0001). Among patients with POPF, RPD remained associated with increased PPH risk (OR 3.15, P =0.0269). Conclusions: RPD reduces the risk of POPF, but may confer greater PPH risk, particularly in patients who develop POPF after RPD. These findings underscore the need for further investigation in the development of POPF after RPD.
BACKGROUND:The increasing adoption of incomplete cholecystectomy in severe cholecystitis has created a growing population of patients who later develop recurrent symptoms from remnant gallbladder or cystic duct pathology. Reoperative cholecystectomy is definitive but technically challenging, and the role of robotic surgery in this setting remains poorly defined. METHODS:A retrospective cohort study was performed of adult patients undergoing robot-assisted completion or remnant cholecystectomy for recurrent gallbladder disease at a single tertiary institution between 2022 and 2024. Perioperative outcomes were evaluated, and institutional primary cholecystectomy outcomes were used as a contextual comparator. RESULTS:Twenty-one patients underwent robotic reoperative cholecystectomy. The median age was 41 years, and most patients were female and obese. All had radiographic evidence of remnant biliary pathology. The median operative time was 166 min, with no intraoperative complications or conversions to open surgery. The median postoperative length of stay was 0 days, with most patients discharged the same day. One patient experienced a 30-day major complication managed nonoperatively. There were no 90-day readmissions or mortalities, and all patients reported symptom resolution. DISCUSSION:In this single-institution series, robotic reoperative cholecystectomy was safe and effective, with minimal morbidity, very short hospital stays, and universal symptom resolution. When performed at experienced centers, robotic reoperative cholecystectomy represents an effective definitive strategy for recurrent gallbladder disease after incomplete cholecystectomy.
659 Background: Early detection of pancreatic ductal adenocarcinoma (PDAC) has a significant impact on pancreatic cancer outcomes. Despite this, 4 in 5 patients are diagnosed at later disease stage where surgery is no longer an option. There is a need for more accurate and less burdensome testing methodology. We previously conducted two independent clinical validation studies (CLARITI and VERIFI) where PancreaSure, a serum-based early detection test for PDAC, showed high accuracy in differentiating early-stage disease versus high-risk control patients. To further understand the performance of the test across a varied patient population, we set out to determine test performance in Stage I-IV PDAC and in healthy controls. Methods: PancreaSure, a biomarker signature comprising a mathematical summation of ICAM-1, THSB1, CTSD, TIMP1, and CA19-9 values with a predefined cutoff to differentiate Stage I and Stage II PDAC from controls at high-risk due to genetic/familial background, was assessed for sensitivity and specificity in detecting Stage III and IV PDAC and in normal, healthy controls. Pooled analysis was conducted to determine weighted performance across all stages of PDAC and in high-risk and healthy controls. Results: The study comprised 317 Stage I-II (early stage) and 152 Stage III-IV (late stage) PDAC cases, 1134 high-risk controls, and 295 healthy controls that were collected from US and European sites. PancreaSure overall weighted sensitivity was 79.8% (73.3-86.4% 95% CI). Sensitivity was 77.6% (73.0-82.2%, 95% CI) in early-stage PDAC and 88.2% (81.8-93.0%, 95% CI) in late-stage PDAC. Overall weighted specificity was 90.8% (87.8-93.8% 95% CI). Specificity was 92.2% (90.6-93.7%, 95% CI) in high-risk controls and 97.7% (95.3-99.1%, 95% CI) in healthy controls. Conclusions: Across a robust clinical experience of almost 1900 patients, PancreaSure showed high accuracy across Stage I-IV PDAC, with improved performance in late-stage disease and in healthy controls. These results support the robustness of the test’s performance and can serve as a tool for both early-stage and late-stage PDAC detection in patients at high and normal risk of pancreatic cancer.
Delayed gastric emptying (DGE) is the most common complication of robot-assisted pancreatoduodenectomy (RPD). Large differences exist in DGE rate between centers and it remains unclear to what extent these are associated with surgical technique. This study assessed differences in DGE rate after RPD and predictors for DGE, including gastrojejunostomy (GJ) technique. Binational, multicenter retrospective cohort study including patients undergoing RPD from seven centers in the United States of America (USA) and the Netherlands (NL) (2011–2023). Data were retrospectively obtained from prospectively maintained databases. Multivariable analysis determined predictors for DGE, including GJ technique. Primary outcomes were DGE (ISGPS grade B/C), primary DGE (i.e., no other abdominal complications), and secondary DGE. Overall, 1,842 patients undergoing RPD were included (USA 1,342, NL 500). Conversion rate was 5.0
Introduction Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) may benefit select patients with peritoneal surface malignancies. The use of a minimally invasive approach may allow for a faster recovery and less morbidity than an open approach. In this video presentation, we describe our technique for minimally invasive CRS+HIPEC. Methods Our video describes the technical aspects of the surgical approach for two patients with peritoneal carcinomatosis who underwent a minimally invasive CRS+HIPEC. Results The first patient is a 58-year-old male who presented with a history of right lower quadrant pain. An abdominal CT scan was read as acute pancreatitis and the patient underwent a laparoscopic appendectomy. However, final pathology revealed a perforated appendix with low-grade appendiceal mucinous neoplasm (LAMN). Pre-operative peritoneal carcinomatosis index (PCI) was estimated as 3. The patient underwent a laparoscopic CRS+HIPEC with mitomycin C. His post-operative course was unremarkable, bowel function returned on postoperative day 2 and he was discharged home on postoperative day 4. The second patient is a 40-year-old female who was diagnosed with an ovarian epithelial carcinoma. She underwent a total abdominal hysterectomy with bilateral salpingo-oophorectomy; however, she subsequently developed an intraperitoneal recurrence. Her estimated PCI was 8. The patient underwent a robotic-assisted CRS+HIPEC with cisplatin. The patient’s post-operative course was unremarkable, and she was discharged home on postoperative day 4. Conclusion Minimally invasive CRS+HIPEC is a safe and feasible option for the treatment of low-volume peritoneal carcinomatosis. The quality of cytoreductive surgery should not be compromised by a minimally invasive approach.
To establish international benchmark values for relevant outcome parameters in robotic Whipple. For safe adoption of surgical innovation, robust quality control is essential. Benchmarking is a validated tool for assessing surgical performance. Recent international consensus identified establishing benchmark values for robotic Whipple as top priority. We analyzed consecutive patients undergoing robotic Whipple between 2020-2023 with a minimum one-year follow-up. Reference centers were required to perform ≥15 cases/year, be scientifically active in the field, and maintain a prospective database. Benchmark criteria included benign or resectable malignant disease without neoadjuvant therapy, arterial resection, major co-morbidities, or significant previous abdominal surgery. Benchmarks were established for 13 outcome parameters. The benchmark cohort comprised 418 patients from 12 centers across four continents. Benchmark values were: conversion rate ≤4.3%, transfusion rate ≤2.1%, 6-month mortality ≤2.2%, major complications ≤23.2%, and CCI® ≤20.9. Clinically relevant pancreatic fistula (grade B/C) and hemorrhage (grade B/C) rates were ≤23.6% and ≤12.7%, respectively. For pancreatic ductal adenocarcinoma (n=123), the benchmark for lymph node yield was ≥20. Higher surgical difficulty was associated with increased overall postoperative morbidity (R 2 =0.38, P =0.019), higher center caseload with reduced pancreas-specific complications (R 2 =0.28, P =0.044). Independent POPF predictors included duct diameter ≤4 mm (OR 1.37, 95% CI: 1.03, 1.82), anticoagulation (OR 2.45, 95% CI: 1.47, 3.99), and indication other than PDAC (OR 2.33, 95% CI: 1.68, 3.27). This study establishes the first international benchmarks for robotic Whipple, demonstrating oncologic outcomes and morbidity comparable to open surgery with the benefits of minimally invasive surgery.
BACKGROUND:Pancreaticoduodenectomy (Whipple procedure) is rarely required in children, but remains the standard of care for resectable pancreatic head tumors. Robotic pancreaticoduodenectomy (RPD) has been increasingly performed in adults, demonstrating safety, feasibility, and in some series, superior perioperative outcomes compared with open surgery. In children, however, there are only three published case reports worldwide. METHODS:We describe two adolescent females with pancreatic head solid pseudopapillary neoplasms (SPNs) who underwent RPD at high-volume U.S. CENTERS:Both cases were managed by multidisciplinary teams including pediatric surgeons and adult surgical oncologists experienced in robotic pancreatic surgery. RESULTS:Case 1: A 13-year-old underwent robotic pylorus-preserving pancreaticoduodenectomy utilizing intraoperative Indocyanine Green Firefly and ultrasound to assess critical anatomy. Reconstruction was performed with Blumgart pancreaticojejunostomy and hepaticojejunostomy. She advanced to diet by postoperative day (POD) 3 and was discharged on POD 3. Case 2: A 17-year-old underwent RPD with pylorus preservation in a similar fashion at an adult hospital. Her recovery was uncomplicated, drains were removed on POD 4, and she was discharged on POD 5. Final pathology in both patients confirmed SPN with negative margins. CONCLUSIONS:These represent the first pediatric RPDs reported in the United States and the first using the da Vinci Xi platform. Our experience demonstrates that pediatric RPD is feasible and safe when performed in collaboration with high-volume adult robotic pancreatic programs. Given the rarity of pediatric pancreatic tumors, collaborative registries and continued reporting are essential to define outcomes and guide best practice.
Abstract Background Emerging evidence suggests irreversible electroporation (IRE) with standard-of-care (SOC) chemotherapy may improve survival in patients with Stage 3 pancreatic ductal adenocarcinoma (PDAC) when compared to SOC alone. This study evaluates the overall survival (OS) and progression-free survival (PFS) of Stage 3 PDAC patients treated with SOC plus IRE with the NanoKnife System versus SOC alone. Methods This prospective, multicenter study included two cohorts from the DIRECT registry: an IRE cohort from sites offering IRE as part of clinical care, and a comparator SOC cohort of prospectively enrolled and contemporaneous retrospective patients. Enrollment spanned 08/05/2019 to 02/05/2023, with follow-up through at least 24 months, death, or loss to follow-up. Included were 137 patients (99 IRE; 38 SOC), aged ≥18 years with Stage 3 PDAC and no progression after three months of SOC therapy. Results Median (interquartile range) time from diagnosis to enrollment was 8 (6-10) months for IRE and 4 (3-6) for SOC (p<0.0001). Median OS and PSF from enrollment were 18 (95% confidence interval [CI]: 15-24) months and 9 (95% CI: 7-12) months for IRE, and 10 (95% CI: 8-14) months and 6 (5-8) months for SOC, respectively (p<0.0001 and p=0.009). Adverse events occurred in 80% (79/99) of IRE patients and 95% (36/38) of SOC patients; 29% (29/99) of the IRE cohort experiencing an IRE-related adverse event. Conclusions IRE was associated with improved OS versus SOC alone and may be an effective consolidative treatment for Stage 3 PDAC after three months of induction chemotherapy.