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OBJECTIVE: To develop and analyze a risk-adjusted cumulative sum (RA-CUSUM) chart as a potential method to monitor individual surgeon performance in robotic total mesorectal excision (TME) for rectal cancer. SUMMARY BACKGROUND DATA: Currently, surgeons lack real-time tools to monitor and enhance their performance beyond residency completion. While national quality programs exist, granular, individual-level data is crucial for continuous improvement. Previous studies suggest CUSUM charts hold promise in identifying performance trends and outliers. METHODS: This retrospective study analyzed data from 640 robotic TME cases performed by 12 surgeons at two institutions. RA-CUSUM charts were generated for three outcomes: complications, operative time, and length of stay. RESULTS: The overall RA-CUSUM curves for operative time and complications showed an initial learning phase followed by a plateau or downward slope, indicating proficiency or improvement. However, individual surgeon curves revealed significant heterogeneity. Three surgeons consistently excelled in operative time, while five minimized complications most effectively. Potential quality improvement could be implemented to drive performance toward positive outliers. No differences were found in unadjusted outcomes, including conversion, number of lymph nodes harvested, and positive circumferential margins. CONCLUSIONS: The RA-CUSUM chart is a promising method for identifying individual surgeon performance in robotic TME. It could help surgeons, teams, and leaders identify improvement areas and benchmark themselves against positive outliers. Further studies are needed to explore the potential of RA-CUSUM for implementing interventions to improve surgical quality.
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OBJECTIVE: This study aims to assess the costs of a Same-Day Discharge Enhanced Recovery Pathway (SDD) for diverting loop ileostomy closure compared to a standard institutional enhanced recovery protocol (ERP). SUMMARY BACKGROUND DATA: Every year, 50,155 patients in the United States undergo temporary stoma reversal. While ambulatory stoma closure has shown promise, widespread adoption remains slow. This study builds on previous research, focusing on the costs of a novel SDD protocol introduced in 2020. METHODS: A retrospective case-control study was conducted at Mayo Clinic, Rochester, Minnesota, and Mayo Clinic, Jacksonville, Florida, comparing patients undergoing same-day discharge diverting loop ileostomy closure (SDD) from August 2020 to February 2023 to those in a matched cohort receiving standard inpatient ERP. Patients were matched based on age, sex, ASA score, surgery period, and hospital. Primary outcomes included direct hospitalization and additional costs in the 30 days post-discharge. RESULTS: The SDD group (n=118) demonstrated a significant reduction in median index episode hospitalization and 30-day post-operative costs compared to the inpatient group (n=236), with savings of $4,827 per patient. Complication rates were similar, and so were readmission and reoperation rates. CONCLUSIONS: Implementation of the SDD for diverting loop ileostomy closure is associated with substantial cost savings without compromising patient outcomes. The study advocates for a shift towards same-day discharge protocols, offering economic benefits and potential improvements in healthcare resource utilization.
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OBJECTIVE: To compare robotic-assisted proctectomy with ileal pouch-anal anastomosis (R-IPAA) outcomes and laparoscopic proctectomy with ileal pouch-anal anastomosis (L-IPAA) within a specialized robotic surgery center, using matching techniques to minimize potential confounding factors. SUMMARY BACKGROUND DATA: Minimally invasive approaches, particularly laparoscopy, have improved outcomes for IBD and FAP patients undergoing IPAA. Robotic-assisted surgery offers potential technical advantages, but its definitive superiority over laparoscopy in this context remains under debate. METHODS: This retrospective, STROBE-compliant study analyzed 234 consecutive IPAA patients (117 robotic, 117 laparoscopic). Data encompassed patient demographics, intraoperative details, and postoperative outcomes. We employed various matching techniques to address potential bias. Primary endpoints focused on 30-day complications, readmissions, and reoperations, with secondary endpoints including hospital stay, blood loss, and stoma closure rates. RESULTS: R-IPAA demonstrated a lower conversion rate to open surgery (P=0.02), a shorter hospital stay (P=0.04), and reduced blood loss (P=0.0003) compared to L-IPAA. While overall 30-day morbidity rates were similar (P=0.4), matched analyses suggested a trend towards fewer reoperations and 3-month IPAA-associated complications after diverting loop ileostomy closure in the robotic group. However, these differences did not reach statistical significance. CONCLUSIONS: In a high-volume robotic surgery center, R-IPAA reduced the risk of conversion to open surgery while reducing intraoperative blood loss and providing shorter length of stay with equivalent perioperative outcomes. Promising trends to reduce 30-day reoperations and surgical complications following DLI closure were observed after a matching analysis.
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INTRODUCTION: Presacral neuroendocrine neoplasms (PNENs) are rare tumors, with limited data on management and outcomes. METHODS: A retrospective review of institutional medical records was conducted to identify all patients with PNENs between 2008 and 2022. Data collection included demographics, symptoms, imaging, surgical approaches, pathology, complications, and long-term outcomes. RESULTS: Twelve patients were identified; two-thirds were female, averaging 44.8 years of age, and, for the most part, presenting with back pain, constipation, and abdominal discomfort. Preoperative imaging included computed tomography scans and magnetic resonance images, with somatostatin receptor imaging and biopsies being common. Half of the patients had metastatic disease on presentation. Surgical approach varied, with anterior, posterior, and combined techniques used, often involving muscle transection and coccygectomy. Short-term complications affected one-quarter of patients. Pathologically, PNENs were mainly well-differentiated grade 2 tumors with positive synaptophysin and chromogranin A. Associated anomalies were common, with tail-gut cysts prevalent. Mean tumor diameter was 6.3 cm. Four patients received long-term adjuvant therapy. Disease progression necessitated additional interventions, including surgery and various chemotherapy regimens. Skeletal, liver, thyroid, lung, and pancreatic metastases occurred during follow-up, with no mortality reported. Kaplan-Meier analysis showed a 5-year local recurrence rate of 23.8%, disease progression rate of 14.3%, and de novo metastases rate of 30%. CONCLUSION: The study underscores the complex management of PNENs and emphasizes the need for multicenter research to better understand and manage these tumors. It provides valuable insights into surgical outcomes, recurrence rates, and overall survival, guiding future treatment strategies for PNEN patients.
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Tumores Neuroendocrinos , Humanos , Femenino , Masculino , Estudios Retrospectivos , Tumores Neuroendocrinos/cirugía , Tumores Neuroendocrinos/patología , Persona de Mediana Edad , Adulto , Tasa de Supervivencia , Estudios de Seguimiento , Anciano , Pronóstico , Sacro/cirugía , Sacro/patología , Recurrencia Local de Neoplasia/cirugía , Recurrencia Local de Neoplasia/patologíaRESUMEN
BACKGROUND: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel, minimally invasive, safe, and repeatable method to treat carcinomatosis. Evidence regarding the clinical benefit (quality of life and survival) of PIPAC compared with that of conventional standard therapy (ST) is lacking. METHODS: This is the secondary analysis of the phase 1 US-PIPAC trial for refractory colorectal and appendiceal carcinomatosis. A PIPAC cohort was compared with a retrospective cohort of consecutive patients receiving ST. The primary outcome was number of good days (number of days alive and out of the hospital). The secondary outcomes were overall survival (OS), progression-free survival (PFS), health-related quality of life (HRQoL), and objective functional recovery (daily step count). RESULTS: The study included 32 patients (PIPAC, 12; ST, 20) with similar baseline characteristics. Compared with the ST cohort, the PIPAC cohort had lower median inpatient hospital stays (> 24 h) within 6 months (0 vs 1; p = 0.015) and 1 year (1 vs 2; p = 0.052) and higher median good days at 6 months (181 vs 131 days; p = 0.042) and 1 year (323 vs 131 days; p = 0.032). There was no worsening of HRQoL after repeated PIPACs. Step counts diminished immediately after PIPAC but returned to baseline within 2-4 weeks. Kaplan-Meier analysis demonstrated a favorable association between receipt of PIPAC and OS (median, 11.3 vs 5.1 months; p = 0.036). CONCLUSION: Compared with ST, PIPAC was associated with higher number of good days, reduced hospitalization burden, and longer OS without a negative impact on HRQoL with repeated PIPACs. These findings are foundational for evaluation of PIPAC in a randomized clinical trial.
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Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias del Apéndice , Neoplasias Colorrectales , Oxaliplatino , Calidad de Vida , Humanos , Femenino , Masculino , Persona de Mediana Edad , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/mortalidad , Tasa de Supervivencia , Neoplasias del Apéndice/patología , Neoplasias del Apéndice/mortalidad , Neoplasias del Apéndice/tratamiento farmacológico , Neoplasias del Apéndice/terapia , Oxaliplatino/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Anciano , Pronóstico , Estudios de Seguimiento , Estudios Retrospectivos , Recuperación de la Función , Aerosoles , Neoplasias Peritoneales/tratamiento farmacológico , Neoplasias Peritoneales/secundario , Neoplasias Peritoneales/mortalidad , AdultoRESUMEN
BACKGROUND: Concerns persist regarding the effectiveness of robotic proctectomy compared with open proctectomy for locally advanced rectal cancer with a high risk of circumferential resection margin involvement. OBJECTIVE: Comparison of surrogate cancer outcomes after robotic versus open proctectomy in this subpopulation. DESIGN: Retrospective cohort study. SETTING: Three academic hospitals (Mayo Clinic Arizona, Florida, and Rochester) with data available through the Mayo Data Explorer platform. PATIENTS: Patients at high risk of circumferential resection margin involvement were selected on the basis of the MRI-based definition from the MERCURY I and II trials. MAIN OUTCOME MEASURES: Rate of pathologic circumferential resection margin involvement (≤1 mm), mesorectal grading, and rate of distal margin involvement. RESULTS: Out of 413 patients, 125 (30%) underwent open and 288 (70%) underwent robotic proctectomy. Open proctectomy was significantly associated with a greater proportion of cT4 tumors (39.3% vs 24.8%, p = 0.021), multivisceral/concomitant resections (40.8% vs 18.4%, p < 0.001), and less frequent total neoadjuvant therapy use (17.1% vs 47.1%, p = 0.001). Robotic proctectomy was less commonly associated with pathologic circumferential resection margin involvement (7.3% vs 17.6%, p = 0.002), including after adjustment for cT stage, neoadjuvant therapy, and multivisceral resection (OR 0.326; 95% CI, 0.157-0.670, p = 0.002). Propensity score matching for 66 patients per group and related multivariable analysis no longer indicated any reduction of circumferential positive margin rate associated with robotic surgery ( p = 0.86 and p = 0.18). Mesorectal grading was comparable (incomplete mesorectum in 6% robotic proctectomy patients vs 11.8% open proctectomy patients, p = 0.327). All cases had negative distal resection margins. LIMITATION: Retrospective design. CONCLUSIONS: In patients with locally advanced rectal cancer at high risk of circumferential resection margin involvement, robotic proctectomy is an effective approach and could be pursued when technically possible as an alternative to open proctectomy. See Video Abstract . RESULTADOS COMPARATIVOS ENTRE LA PROCTECTOMA ROBTICA Y LA PROCTECTOMA ABIERTA EN CASOS DE CNCER DE RECTO CON ALTO RIESGO DE MRGEN DE RESECCIN CIRCUNFERENCIAL POSITIVO: ANTECEDENTES:Persisten preocupaciones con respecto a la efectividad de la proctectomía robótica en comparación con la proctectomía abierta en casos de cáncer de recto localmente avanzado con un alto riesgo de margen de resección circunferencial positivo.OBJETIVO:Comparar los resultados en la subpoblación de portadores de cáncer luego de una proctectomía robótica versus una proctectomía abierta.DISEÑO:Estudio retrospectivo de cohortes.AJUSTE:Realizado en tres hospitales académicos (Mayo Clinic de Arizona, Florida y Rochester) a través de la plataforma Mayo Data Explorer.PACIENTES:Fueron seleccionados aquellos pacientes con alto riesgo de compromiso sobre el margen de resección circunferencial, según la definición de los Estudios Mercury I-II basada en la Imágen de Resonancia Magnética.MEDIDAS DE RESULTADO PRINCIPALES Y SECUNDARIAS:La tasa de compromiso patológico sobre el margen de resección circunferencial (≤1 mm), la clasificación mesorrectal y la tasa del compromiso del margen distal.RESULTADOS:De 413 pacientes, 125 (30%) fueron sometidos a una proctectomía abierta y 288 (70%) a proctectomía robótica. La proctectomía abierta se asoció significativamente con una mayor proporción de tumores cT4 (39,3% frente a 24,8%, p = 0,021), las resecciones multiviscerales/concomitantes fueron de 40,8% frente a 18,4%, p < 0,001 y una adminstración menos frecuente de terapia neoadyuvante total (17,1). % vs 47,1%, p = 0,001).La proctectomía robótica se asoció con menos frecuencia con la presencia de una lesión sobre el margen de resección circunferencial patológico (7,3% frente a 17,6%, p = 0,002), incluso después del ajuste por estadio cT, de la terapia neoadyuvante y de resección multivisceral (OR 0,326, IC 95% 0,157-0,670, p = 0,002). El apareado de propensión por puntuación en 66 pacientes por grupo y el análisis multivariable relacionado, no mostraron ninguna reducción en la tasa de margen positivo circunferencial asociado con la cirugía robótica ( p = 0,86 y p = 0,18). La clasificación mesorrectal fue igualmente comparable (mesorrecto incompleto en el 6% de los pacientes con RP frente al 11,8% de los pacientes con OP, p = 0,327). Todos los casos tuvieron márgenes de resección distal negativos.LIMITACIÓN:Diseño retrospectivo.CONCLUSIÓN:En pacientes con cáncer de recto localmente avanzado con alto riesgo de compromiso del margen de resección circunferencial, la proctectomía robótica es un enfoque eficaz y podría realizarse cuando sea técnicamente posible como alternativa a la proctectomía abierta. (Traducción-Dr. Xavier Delgadillo ).
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Márgenes de Escisión , Proctectomía , Neoplasias del Recto , Procedimientos Quirúrgicos Robotizados , Humanos , Neoplasias del Recto/cirugía , Neoplasias del Recto/patología , Procedimientos Quirúrgicos Robotizados/métodos , Masculino , Femenino , Proctectomía/métodos , Persona de Mediana Edad , Estudios Retrospectivos , Anciano , Resultado del Tratamiento , Estadificación de Neoplasias , Imagen por Resonancia Magnética/métodos , Terapia Neoadyuvante/métodos , Clasificación del TumorRESUMEN
AIM: Recent evidence challenges the current standard of offering surgery to patients with ileocaecal Crohn's disease (CD) only when they present complications of the disease. The aim of this study was to compare short-term results of patients who underwent primary ileocaecal resection for either inflammatory (luminal disease, earlier in the disease course) or complicated phenotypes, hypothesizing that the latter would be associated with worse postoperative outcomes. METHOD: A retrospective, multicentre comparative analysis was performed including patients operated on for primary ileocaecal CD at 12 referral centres. Patients were divided into two groups according to indication of surgery for inflammatory (ICD) or complicated (CCD) phenotype. Short-term results were compared. RESULTS: A total of 2013 patients were included, with 291 (14.5%) in the ICD group. No differences were found between the groups in time from diagnosis to surgery. CCD patients had higher rates of low body mass index, anaemia (40.9% vs. 27%, p < 0.001) and low albumin (11.3% vs. 2.6%, p < 0.001). CCD patients had longer operations, lower rates of laparoscopic approach (84.3% vs. 93.1%, p = 0.001) and higher conversion rates (9.3% vs. 1.9%, p < 0.001). CCD patients had a longer hospital stay and higher postoperative complication rates (26.1% vs. 21.3%, p = 0.083). Anastomotic leakage and reoperations were also more frequent in this group. More patients in the CCD group required an extended bowel resection (14.1% vs. 8.3%, p: 0.017). In multivariate analysis, CCD was associated with prolonged surgery (OR 3.44, p = 0.001) and the requirement for multiple intraoperative procedures (OR 8.39, p = 0.030). CONCLUSION: Indication for surgery in patients who present with an inflammatory phenotype of CD was associated with better outcomes compared with patients operated on for complications of the disease. There was no difference between groups in time from diagnosis to surgery.
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Enfermedad de Crohn , Íleon , Fenotipo , Complicaciones Posoperatorias , Humanos , Enfermedad de Crohn/cirugía , Enfermedad de Crohn/complicaciones , Femenino , Estudios Retrospectivos , Masculino , Adulto , Resultado del Tratamiento , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Persona de Mediana Edad , Íleon/cirugía , Adulto Joven , Ciego/cirugía , Laparoscopía/métodos , Laparoscopía/estadística & datos numéricos , Laparoscopía/efectos adversos , Tempo Operativo , Tiempo de Internación/estadística & datos numéricos , Factores de TiempoRESUMEN
BACKGROUND: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a laparoscopic locoregional treatment for peritoneal metastases (PM) from colorectal cancer (CRC) or appendiceal cancer (AC) in patients who cannot undergo cytoreductive surgery (CRS). While PIPAC has been studied in Europe and Asia, it has not been investigated in the USA. PATIENTS AND METHODS: We evaluated PIPAC with 90 mg/m2 oxaliplatin alone (cycle 1) and preceded by systemic chemotherapy with fluorouracil (5-FU) and leucovorin (LV) (cycle 2-3) as a multicenter prospective phase I clinical trial (NCT04329494). The primary endpoint was treatment-related adverse events (AEs). Secondary endpoints included survival and laparoscopic, histologic, and radiographic response. RESULTS: 12 patients were included: 8 with CRC and 4 with AC. Median prior chemotherapy cycles was 2 (interquartile range (IQR) 2-3). All patients were refractory to systemic oxaliplatin-based chemotherapy. Median peritoneal carcinomatosis index (PCI) was 28 (IQR 19-32). Six (50%) of twelve patients completed three PIPAC cycles. No surgical complications or dose-limiting toxicities were observed. Two patients developed grade 3 treatment-related toxicities (one abdominal pain and one anemia). Median overall survival (OS) was 12.0 months, and median progression-free survival (PFS) was 2.9 months. OS was correlated with stable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria but not with laparoscopic response by PCI or histologic response by peritoneal regression grading system (PRGS). CONCLUSIONS: This phase I trial in the USA demonstrated safety, feasibility, and early efficacy signal of PIPAC with oxaliplatin and chemotherapy in patients with PM from AC or CRC who are refractory to standard lines of systemic chemotherapy.
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Neoplasias del Apéndice , Neoplasias Colorrectales , Neoplasias Peritoneales , Humanos , Oxaliplatino , Neoplasias del Apéndice/tratamiento farmacológico , Neoplasias Peritoneales/secundario , Estudios Prospectivos , Aerosoles , Fluorouracilo/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patologíaRESUMEN
BACKGROUND: Acute diverticulitis in immunocompromised patients is associated with high morbidity and mortality rates with either medical or surgical treatment. Thus, management approach is controversial, especially for patients presenting with nonperforated disease. OBJECTIVE: This study aimed to report the Mayo clinic experience of acute diverticulitis management in immunocompromised patients. DESIGN: This design is based on a retrospective cohort study. SETTING: This study was conducted with institutional data composed from 3 tertiary referral centers. PATIENTS: Immunocompromised patients presenting with acute diverticulitis at 3 Mayo clinic sites between 2016 and 2020 were included. MAIN OUTCOME MEASURES: The main outcome measures were the management algorithm and short-term outcomes. RESULTS: Immunocompromised patients presenting with acute uncomplicated diverticulitis (86) were all managed nonoperatively at presentation with a success rate of 93% (80/86). Two patients (2.3%, 2/86) required surgery during the same admission, and 4 patients (4.8%, 4/84) had 30-day readmission. Complicated diverticulitis patients with abscess (22) were all managed nonoperatively first with a success rate of 95.4% (21/22). One patient (4.6%, 1/22) required surgery during the same admission. All the patients who presented with obstruction (2), fistula (1), or free perforation (11) underwent surgery except one who chose hospice. Overall, the major complication rate was 50% (8/16) and mortality rate was 18.8% (3/16) among patients who underwent surgery during the same admission. For patients who presented with perforated diverticulitis, the mortality rate was 27.3% (3/11), compared with 0% (0/111) for patients who presented with nonperforated disease. LIMITATIONS: This cohort was limited by its retrospective nature and heterogeneity of the patient population. CONCLUSIONS: Nonoperative management was safe and feasible for immunocompromised patients with colonic diverticulitis without perforation at our center. Perforated colonic diverticulitis in immunocompromised patients was associated with high morbidity and mortality rate. See Video Abstract at http://links.lww.com/DCR/B988 .MANEJO DE LA DIVERTICULITIS AGUDA EN PACIENTES INMUNOCOMPROMETIDOS: EXPERIENCIA DE LA CLINICA MAYOANTECEDENTES:La diverticulitis aguda en pacientes inmunocomprometidos se asocia con una alta tasa de morbilidad y mortalidad con el tratamiento médico o quirúrgico. Por lo tanto, el enfoque de manejo es controvertido, especialmente para pacientes que presentan enfermedad no perforada.OBJETIVO:El propósito fue informar la experiencia de la clínica Mayo en el manejo de la diverticulitis aguda en pacientes inmunocomprometidos.DISEÑO:Este es un estudio de cohorte retrospectivoENTORNO CLÍNICO:Este estudio se realizó con datos institucionales compuestos de tres centros de referencia terciarios.PACIENTES:Se incluyeron pacientes inmunocomprometidos que presentaron diverticulitis aguda en tres sitios de la clínica Mayo entre 2016 y 2020.RESULTADO PRINCIPAL:Algoritmo de gestión y resultados a corto plazo.RESULTADOS:Los pacientes inmunocomprometidos que presentaban diverticulitis aguda no complicada (86) fueron tratados de forma no quirúrgica en la presentación inicial con una tasa de éxito del 93 % (80/86). Dos pacientes (2,3%, 2/86) requirieron cirugía durante el mismo ingreso y cuatro pacientes (4,8%, 4/84) tuvieron reingreso a los 30 días. Todos los pacientes con diverticulitis complicada con absceso (22) fueron tratados primero de forma no quirúrgica con una tasa de éxito del 95,4 % (21/22). Un paciente (4,6%, 1/22) requirió cirugía durante el mismo ingreso. Todos los pacientes que presentaron obstrucción (2), fístula (1) o perforación libre (11) fueron intervenidos excepto uno que optó por hospicio. La tasa global de complicaciones mayores fue del 50 % (8/16) y la tasa de mortalidad fue del 18,8 % (3/16) entre los pacientes que se sometieron a cirugía durante el mismo ingreso. Para los pacientes que presentaban diverticulitis perforada, la tasa de mortalidad fue del 27,3 % (3/11), en comparación con el 0 % (0/111) de los pacientes que presentaban enfermedad no perforada.LIMITACIONES:Esta cohorte estuvo limitada por su naturaleza retrospectiva y la heterogeneidad de la población de pacientes. CONCLUSINES: El manejo no quirúrgico fue seguro y factible para pacientes inmunocomprometidos con diverticulitis colónica sin perforación en nuestro centro. La diverticulitis colónica perforada en pacientes inmunocomprometidos se asoció con una alta tasa de morbilidad y mortalidad. Consulte Video Resumen en http://links.lww.com/DCR/B988 . (Traducción- Dr. Ingrid Melo ).
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Diverticulitis del Colon , Diverticulitis , Humanos , Estudios Retrospectivos , Diverticulitis del Colon/complicaciones , Diverticulitis del Colon/terapia , Diverticulitis/complicaciones , Diverticulitis/terapia , Huésped InmunocomprometidoRESUMEN
BACKGROUND: Peritoneal metastases (PM) from ovarian, gastric, appendiceal, or colorectal origin can be treated via cytoreductive surgery with or without the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) for selected patients. Unfortunately, not all patients are candidates for aggressive surgical debulking. For these patients, pressurized intraperitoneal aerosolized chemotherapy (PIPAC) has emerged as an alternative method for intraperitoneal (IP) chemotherapy administration. This report presents the design and implementation of the first phase 1 trial to evaluate the safety and efficacy of PIPAC in the United States. METHODS: This is an ongoing prospective phase 1 clinical trial of PIPAC for patients who have histologically confirmed ovarian, uterine, gastric, appendiceal, or colorectal cancer with PM and have progressed to at least one evidence-based chemotherapeutic regimen. The trial has two clinical arms. The patients in arm 1 have gynecologic and gastric malignancies treated with IP cisplatin and doxorubicin, and the arm 2 patients have colorectal and appendiceal malignancies treated with intravenous fluorouracil and leucovorin followed by IP oxaliplatin. All the patients are monitored for dose-limiting toxicities and adverse events. RESULTS: Practical and technical considerations for the phase 1 PIPAC trial are presented. These considerations include patient selection, operating room setup, and technical details for successful aerosolized chemotherapy delivery. The phase 1 study results will be reported separately at completion of the trial. CONCLUSIONS: The PIPAC treatment is a feasible, minimally invasive approach that permits IP delivery of chemotherapy. Once completed, the ongoing phase 1 trial will help to provide safety and initial efficacy data.
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Neoplasias Peritoneales , Femenino , Humanos , Neoplasias Peritoneales/tratamiento farmacológico , Estudios ProspectivosRESUMEN
BACKGROUND: Intraoperative frozen-section analysis provides real-time margin resection status that can guide intraoperative decisions made by the surgeon and radiation oncologist. For patients with locally recurrent rectal cancer undergoing surgery and intraoperative radiation therapy, intraoperative re-resection of positive margins to achieve negative margins is common practice. OBJECTIVE: This study aimed to assess whether re-resection of positive margins found on intraoperative frozen-section analysis improves oncologic outcomes. DESIGN: This is a retrospective cohort study. SETTINGS: This study was an analysis of a prospectively maintained multicenter database. PATIENTS: All patients who underwent surgical resection of locally recurrent rectal cancer with intraoperative radiation therapy between 2000 and 2015 were included and followed for 5 years. Three groups were compared: initial R0 resection, initial R1 converted to R0 after re-resection, and initial R1 that remained R1 after re-resection. Grossly positive margin resections (R2) were excluded. MAIN OUTCOME MEASURES: The primary outcome measures were 5-year overall survival, recurrence-free survival, and local re-recurrence. RESULTS: A total of 267 patients were analyzed (initial R0 resection, n = 94; initial R1 converted to R0 after re-resection, n = 95; initial R1 that remained R1 after re-resection, n = 78). Overall survival was 4.4 years for initial R0 resection, 2.7 years for initial R1 converted to R0 after re-resection, and 2.9 years for initial R1 that remained R1 after re-resection ( p = 0.01). Recurrence-free survival was 3.0 years for initial R0 resection and 1.8 years for both initial R1 converted to R0 after re-resection and initial R1 that remained R1 after re-resection ( p ≤ 0.01). Overall survival did not differ for patients with R1 and re-resection R1 or R0 ( p = 0.62). Recurrence-free survival and freedom from local re-recurrence did not differ between groups. LIMITATIONS: This study was limited by the heterogeneous patient population restricted to those receiving intraoperative radiation therapy. CONCLUSIONS: Re-resection of microscopically positive margins to obtain R0 status does not appear to provide a significant survival advantage or prevent local re-recurrence in patients undergoing surgery and intraoperative radiation therapy for locally recurrent rectal cancer. See Video Abstract at http://links.lww.com/DCR/B886 . LA RERESECCIN DE LOS MRGENES MICROSCPICAMENTE POSITIVOS ENCONTRADOS DE MANERA INTRAOPERATORIA MEDIANTE LA TCNICA DE CRIOSECCIN, NO DA COMO RESULTADO UN BENEFICIO DE SUPERVIVENCIA EN PACIENTES SOMETIDOS A CIRUGA Y RADIOTERAPIA INTRAOPERATORIA PARA EL CNCER RECTAL LOCALMENTE RECIDIVANTE: ANTECEDENTES:El análisis de la ténica de criosección para los margenes positivos encontrados de manera intraoperatoria proporciona el estado de la resección del margen en tiempo real que puede guiar las decisiones intraoperatorias tomadas por el cirujano y el oncólogo radioterapeuta. Para los pacientes con cáncer de recto localmente recurrente que se someten a cirugía y radioterapia intraoperatoria, la re-resección intraoperatoria de los márgenes positivos para lograr márgenes negativos es una práctica común.OBJETIVO:Evaluar si la re-resección de los márgenes positivos encontrados en el análisis de la ténica por criosecciónde manera intraoperatorios mejora los resultados oncológicos.DISEÑO:Estudio de cohorte retrospectivo.AJUSTES:Análisis de una base de datos multicéntrica mantenida de forma prospectiva.POBLACIÓN:Todos los pacientes que se sometieron a resección quirúrgica de cáncer de recto localmente recurrente con radioterapia intraoperatoria entre 2000 y 2015 fueron incluidos y seguidos durante 5 años. Se compararon tres grupos: resección inicial R0, R1 inicial convertido en R0 después de la re-resección y R1 inicial que permaneció como R1 después de la re-resección. Se excluyeron las resecciones de márgenes macroscópicamente positivos (R2).PRINCIPALES MEDIDAS DE RESULTADO:Supervivencia global a cinco años, supervivencia sin recidiva y recidiva local.RESULTADOS:Se analizaron un total de 267 pacientes (resección inicial R0 n = 94, R1 inicial convertido en R0 después de la re-resección n = 95, R1 inicial que permaneció como R1 después de la re-resección n = 78). La supervivencia global fue de 4,4 años para la resección inicial R0, 2,7 años para la R1 inicial convertida en R0 después de la re-resección y 2,9 años para la R1 inicial que permaneció como R1 después de la re-resección ( p = 0,01). La supervivencia libre de recurrencia fue de 3,0 años para la resección inicial R0 y de 1,8 años para el R1 inicial convertido en R0 después de la re-resección y el R1 inicial que permaneció como R1 después de la re-resección ( p ≤ 0,01). La supervivencia global no difirió para los pacientes con R1 y re-resección R1 o R0 ( p = 0,62). La supervivencia libre de recurrencia y la ausencia de recurrencia local no difirieron entre los grupos.LIMITACIONES:Población de pacientes heterogénea, restringida a aquellos que reciben radioterapia intraoperatoria.CONCLUSIONES:La re-resección de los márgenes microscópicamente positivos para obtener el estado R0 no parece proporcionar una ventaja de supervivencia significativa o prevenir la recurrencia local en pacientes sometidos a cirugía y radioterapia intraoperatoria para el cáncer de recto localmente recurrente. Consulte Video Resumen en http://links.lww.com/DCR/B886 . (Traducción-Dr. Daniel Guerra ).
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Secciones por Congelación , Neoplasias del Recto , Estudios de Seguimiento , Humanos , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/cirugía , Estadificación de Neoplasias , Neoplasias del Recto/radioterapia , Neoplasias del Recto/cirugía , Estudios RetrospectivosRESUMEN
AIM: The existing literature was updated, assessing the use of surgery in patients with ulcerative colitis in more recent years. METHODS: This was a retrospective observational study identifying all patients with ulcerative colitis within the National Inpatient Sample, years 2009-2018. All patients with International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification diagnostic codes for ulcerative colitis were included. The primary outcome was the trend in total number of total abdominal colectomy, proctocolectomy and simultaneous versus delayed pouch construction. RESULTS: A total of 1 184 711 ulcerative-colitis-related admissions were identified. An increase of 18.6% in the number of patients was observed, while the number of surgeries decreased. A total of 40 499 patients underwent total colectomy, annually decreasing from 5241 to 3185. The number of proctocolectomies without pouch decreased from 1191 to 530, while the number of patients undergoing pouch construction decreased from 2225 to 1284. The proportion of patients undergoing initial pouch at time of proctocolectomy decreased from 995 (45%) to 265 (21%), while the proportion of patients undergoing delayed pouch construction in 2018 was 79% (n = 1120). CONCLUSION: Surgery use in ulcerative colitis has decreased in the last decade despite increasing numbers of hospital admissions in patients with this condition. While the overall proportion of patients undergoing pouch construction remained stable, the majority of patients were initially treated with total colectomy and their ileal pouches werre constructed in a delayed fashion.
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Colitis Ulcerosa , Reservorios Cólicos , Proctocolectomía Restauradora , Anastomosis Quirúrgica , Colectomía , Colitis Ulcerosa/etiología , Colitis Ulcerosa/cirugía , Humanos , Proctocolectomía Restauradora/efectos adversos , Estudios RetrospectivosRESUMEN
AIM: The aim of this study was to describe the surgical management, outcomes and risk of malignancy of presacral tailgut cysts. METHOD: A retrospective analysis of all patients who underwent resection of tailgut cyst at Mayo Clinic in Arizona, Florida and Minnesota between 2008 and 2020 was performed. Demographics, presentation, evaluation, surgical approach, postoperative complications, pathology and recurrence rates were reviewed. RESULTS: Seventy-three patients were identified (81% female) with a mean age of 45 years. Thirty-nine patients (53%) were symptomatic, most commonly with pelvic pain (26 patients). Digital rectal examination identified a palpable mass in 68%. Mean tumour size was 6 cm. Resection was primarily performed through a posterior approach (77%, n = 56), followed by a transabdominal approach (18%, n = 13) and a combined approach (5%, n = 4). Six patients underwent a minimally invasive resection (laparoscopic/robotic). Coccygectomy or distal sacrectomy was performed in 41 patients (56%). Complete resection was achieved in 94% of patients. Thirty-day morbidity occurred in 18% and was most commonly wound related; there was no mortality. Malignancy was identified in six patients (8%). For the 30 patients with follow-up greater than 1 year, the median follow-up was 39 months (range 1.0-11.1 years). Local recurrence was identified in three patients and distant metastatic disease in one patient. CONCLUSION: The rate of malignancy in presacral tailgut cysts based on this current review was 8%. Overall recurrence was 5% at a median of 24 months.
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Quistes , Hamartoma , Laparoscopía , Quistes/complicaciones , Quistes/cirugía , Femenino , Hamartoma/complicaciones , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/cirugía , Estudios RetrospectivosRESUMEN
OBJECTIVE: To compare short term outcomes of patients undergoing laparoscopic or robotic rectal cancer surgery. BACKGROUND: Significant benefits of robotic rectal cancer surgery over laparoscopy have yet to be demonstrated. Operative time and direct institutional cost seem in favor of the laparoscopic approach. METHODS: We performed a retrospective review of consecutive patients operated on for rectal cancer with a mini-invasive approach at Mayo Clinic from 2005 to 2018. The primary aim of this study was to investigate the difference in postoperative morbidity between the laparoscopic and robotic approach. Multivariable models for odds to complications and prolonged (≥6 days) length of stay were built. RESULTS: A total of 600 patients were included in the analysis. The number of patients undergoing robotic surgery was 317 (52.8%). The 2 groups were similar in respect to age, sex, and body mass index. Laparoscopic surgery was correlated to shorter operative time (214 vs 324âminutes; P < 0.001). Patients undergoing robotic surgery had a lower overall complications rate (37.2% vs 51.2%; P < 0.001). Robotic surgery was found to be the most protective factor [odds ratio (OR) 0.485; P = 0.006] for odds to complications. The event of a complication (OR 9.33; P < 0.001) and conversion to open surgery (OR 3.095; P = 0.002) were identified as risk factors for prolonged length of stay whereas robotic surgery (OR 0.62; P = 0.027) was the only independent protective factor. CONCLUSIONS: Robotic rectal cancer surgery is strongly associated with better short-term outcomes over laparoscopic surgery.
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Neoplasias del Recto/cirugía , Procedimientos Quirúrgicos Robotizados/métodos , Anciano , Femenino , Humanos , Laparoscopía , Masculino , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias/epidemiología , Estudios RetrospectivosRESUMEN
BACKGROUND: To evaluate the economic burden of locally advanced rectal cancer (LARC) treatment from a society perspective through analysis of health insurance-derived data of commercially insured and Medicare Advantage (MA) patients. METHODS: Retrospective cost analysis of patients undergoing rectal resection within a multimodal (neoadjuvant chemoradiation + adjuvant chemotherapy) treatment strategy between January 1, 2010 and October 31, 2018, using the claims OptumLabs Data Warehouse database. RESULTS: In total, 1738 (935 commercial and 803 MA) patients were included. Overall treatment costs totaled $230,881,746 (on average $183 653 ± 82 384 per commercially insured and $73 681 ± 32 917 per MA patient). Cost distribution according to category (commercially insured patients) was: 29.92% related to outpatient care (follow-up visits/diagnostics), radiotherapy: 21.83%, index resection: 20.62%, chemotherapy: 17.44%, surgical inpatient: 6.32%, medical inpatient: 3.28%, emergency room: 0.58%. Relative cost distribution of the index resection itself differed marginally between the three approaches and was 21.49% for open, 19.30% for laparoscopic, and 20.93% for robotic surgery. Relative cost distributions of neoadjuvant, adjuvant, and outpatient treatments remained unchanged, independently of the surgical approach. This representation was similar in MA patients. CONCLUSION: Index-surgery related costs were outweighed by costs related to oncological and outpatient workup/follow-up treatments independently of both surgical approach and insurance type.
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Costo de Enfermedad , Costos de la Atención en Salud/estadística & datos numéricos , Aseguradoras/estadística & datos numéricos , Medicare/estadística & datos numéricos , Terapia Neoadyuvante/economía , Proctectomía/economía , Neoplasias del Recto/economía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Seguro de Salud , Masculino , Persona de Mediana Edad , Pronóstico , Neoplasias del Recto/epidemiología , Neoplasias del Recto/terapia , Estudios Retrospectivos , Tasa de Supervivencia , Estados Unidos/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Utilization of minimally invasive surgery (MIS) has multiple determinants, one being the specialization of the surgeon. The purpose of this study was to assess the differences in the utilization of MIS, associated length of stay (LOS), and complications for colorectal cancer between colorectal (CRS) and general surgeons (GS). Previous studies have documented the influence of surgical volume and surgeon specialty on clinical outcomes and patient survival following colorectal cancer surgery. It is unclear whether there are differences in the utilization of MIS for colorectal cancer based on surgeon's specialization and how this influences clinical outcomes. METHODS: Using the 2013-2015 Florida Inpatient Discharge Dataset and the National Plan & Provider Enumeration System, colorectal cancer patients experiencing a colorectal surgery were identified as well as the operating physician's specialty. Mixed-effects regression models were used to identify associations between the use of MIS, complications during the hospital stay, and patient LOS with patient, physician, and hospital characteristics. RESULTS: There is no difference in the use of MIS, complication, nor LOS between GS and CRS for colorectal cancer surgery. However, physician volume was associated with increased use of MIS (OR 1.26, 95% CI 1.09, 1.46) and MIS was associated with decreases in certain complications as well as reductions in LOS overall (ß = - 0.16, p < 0.001) and for each specialty (GS: ß = - 0.18, p < 0.001; CRS ß = - 0.12, p < 0.001) CONCLUSIONS: Despite the higher amount of proctectomies performed by CRS, no difference in MIS utilization, complication rate, or LOS was found for colorectal cancer patients based on surgeon specialty. While there are some differences in clinical outcomes attributable to specialized training, results from this study indicate that differences in surgical approach (MIS vs. Open), as well as the patient populations encountered by these two specialties, are key factors in the outcomes observed.
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Neoplasias Colorrectales , Cirujanos , Neoplasias Colorrectales/cirugía , Humanos , Tiempo de Internación , Procedimientos Quirúrgicos Mínimamente Invasivos , Complicaciones Posoperatorias/epidemiología , Estudios RetrospectivosRESUMEN
BACKGROUND: Anastomotic leak remains a critical complication after restorative rectal cancer surgery and is associated with significant morbidity and mortality rates, whereas reported rates range from 4% to 29%. Whether the occurrence of leak may have an impact on long-term oncological outcomes is under debate. OBJECTIVE: This study aimed to describe the oncological impact of anastomotic leak on patients undergoing sphincter-preserving surgery for rectal adenocarcinoma. DESIGN: This is a retrospective review of a prospectively maintained database. SETTINGS: The study was conducted at a high-volume colorectal center. PATIENTS: Data on patients who underwent restorative surgery for rectal adenocarcinoma from January 2000 until December 2013 were retrospectively analyzed. MAIN OUTCOME MEASURES: The primary outcome measured was the impact of anastomotic leak, defined according to the classification proposed by the International Study Group of Rectal Cancer, on long-term overall survival, disease-free survival, disease-specific survival, and local recurrence. RESULTS: A total of 787 patients undergoing sphincter-preserving surgery for rectal cancer met the inclusion criteria. Forty-two (5.3%) patients presented a symptomatic anastomotic leak. The median follow-up period was 64 months. Fifty-one (6.5%) patients experienced a cancer-related death, 2 of 42 in the anastomotic leak group. Five-year overall survival, disease-specific survival, and disease-free survival were 88%, 94.7%, and 85.3%. Local recurrence rate was 2%. There was no difference in long-term overall survival, disease-specific survival, disease-free survival, and local recurrence rate between groups. On a multivariable analysis, anastomotic leak did not impact oncological outcomes. LIMITATIONS: This study was limited by retrospective analysis. CONCLUSIONS: The occurrence of anastomotic leak after restorative resection for rectal cancer did not impact long-term oncological outcomes in our cohort of patients. See Video Abstract at http://links.lww.com/DCR/B187. RESULTADOS ONCOLÓGICOS A LARGO PLAZO DESPUÉS DE UNA FUGA ANASTOMÓTICA EN CIRUGÍA DE CÁNCER RECTAL: La fuga anastomótica sigue siendo una complicación crítica después de la cirugía restauradora del cáncer rectal y se asocia con tasas significativas de morbilidad y mortalidad, mientras que las tasas reportadas varían del 4% al 29%. Se está debatiendo si la aparición de fugas puede tener un impacto en los resultados oncológicos a largo plazo.Describir el impacto oncológico de la fuga anastomótica en pacientes sometidos a cirugía de preservación del esfínter para adenocarcinoma rectal.Revisión retrospectiva de una base de datos mantenida prospectivamente.El estudio se realizó en un centro colorrectal de alto volumen.Se analizaron retrospectivamente los datos de pacientes que se sometieron a cirugía reparadora por adenocarcinoma rectal desde Enero de 2000 hasta Diciembre de 2013.Impacto de la fuga anastomótica, definida de acuerdo con la clasificación propuesta por el Grupo de Estudio Internacional del Cáncer Rectal (International Study Group of Rectal Cancer), sobre la supervivencia general a largo plazo, la supervivencia libre de enfermedad, la supervivencia específica de la enfermedad y la recurrencia local.Un total de 787 pacientes sometidos a cirugía para preservar el esfínter por cáncer rectal cumplieron con los criterios de inclusión. Cuarenta y dos (5.3%) pacientes presentaron una fuga anastomótica sintomática. El tiempo mediano del período de seguimiento fue de 64 meses. Cincuenta y un (6.5%) pacientes sufrieron muerte relacionada con el cáncer, 2 de 42 en el grupo de fuga anastomótica. La supervivencia global a cinco años, la supervivencia específica de la enfermedad y la supervivencia libre de enfermedad fueron del 88%, 94.7% y 85.3%, respectivamente. La tasa de recurrencia local fue del 2%. No hubo diferencias en la supervivencia global a largo plazo, la supervivencia específica de la enfermedad, la supervivencia libre de enfermedad y la tasa de recurrencia local entre los grupos. En un análisis multivariable, la fuga anastomótica no afectó los resultados oncológicos.Este estudio fue limitado por análisis retrospectivo.La aparición de fuga anastomótica después de la resección restauradora para el cáncer rectal no afectó los resultados oncológicos a largo plazo en nuestra cohorte de pacientes. Consulte Video Resumen en http://links.lww.com/DCR/B187. (Traducción-Dr. Yesenia Rojas-Kahlil).
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Fuga Anastomótica/etiología , Ileostomía/efectos adversos , Neoplasias del Recto/complicaciones , Neoplasias del Recto/cirugía , Adenocarcinoma/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Manejo de Datos , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Ileostomía/métodos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/epidemiología , Ensayos Clínicos Controlados no Aleatorios como Asunto/métodos , Evaluación de Resultado en la Atención de Salud , Neoplasias del Recto/mortalidad , Estudios RetrospectivosRESUMEN
BACKGROUND: Peritoneal metastases arise in patients with a variety of primary cancers, and are associated with a poor prognosis. Systemic chemotherapy is the mainstay of treatment; however, the morbidity is considerable and the survival benefit is modest. Cytoreductive surgery and heated intraperitoneal chemotherapy is a potentially curative treatment available to a minority of patients; however, most develop recurrent disease. A novel palliative treatment for peritoneal metastases, pressurized intraperitoneal aerosol chemotherapy, has recently been introduced. Pressurized intraperitoneal aerosol chemotherapy utilizes an aerosol of chemotherapy in carbon dioxide gas. It is instilled into the abdomen under pressure via laparoscopic ports. No cytoreduction is performed. Pressurized intraperitoneal aerosol chemotherapy can be repeated at 6-week intervals. Oxaliplatin or cis-platinum and doxorubicin have been used to date. OBJECTIVE: This study aims to systematically review and evaluate the method, and the preclinical and early clinical results of pressurized intraperitoneal aerosol chemotherapy. DATA SOURCES: Medline and the Cochrane Library were the data sources for the study. STUDY SELECTION: Peer-reviewed series of greater than 10 patients, with sufficient patient data, through April 2019, were selected. INTERVENTION: Patients with peritoneal metastases underwent pressurized intraperitoneal aerosol chemotherapy. MAIN OUTCOME MEASURES: Patient dropout, histologic tumor response, adverse events, and 30-day mortality were the primary outcomes measured. RESULTS: A total of 921 patients with peritoneal metastases were brought to the operating room for pressurized intraperitoneal aerosol chemotherapy. The number of pressurized intraperitoneal aerosol chemotherapy treatments administered was as follows: 1 treatment, 862 (94%); 2 treatments, 645 (70%); and 3 treatments, 390 patients (42%). Initial laparoscopic access was not possible in 59 patients (6.4%). Common Terminology Criteria for Adverse Events grade 3 or higher were noted in 13.7% of the patients who, collectively, underwent a total of 2116 treatments. The 30-day mortality was 2.4% (22/921). LIMITATIONS: This study was limited by the heterogeneity of reported data and primary tumor types and by the lack of long-term survival data. CONCLUSIONS: Early clinical results are encouraging, but tumor-specific, prospective, randomized trials are needed to compare pressurized intraperitoneal aerosol chemotherapy to systemic chemotherapy. This method has yet to be introduced to the United States. It is another therapeutic option for patients with peritoneal metastases and will broaden the patient base for future clinical trials.