Improved Survival After Adjuvant Therapy in Locally Advanced Rectal Cancer Patients With Pathologic Complete Response.

BACKGROUND: The benefit of adjuvant therapy is unclear in patients with rectal cancer achieving a pathologic complete response after neoadjuvant chemoradiotherapy and total mesorectal excision. OBJECTIVE: This study aimed to assess the benefit of adjuvant chemotherapy on survival among rectal cancer patients with a pathologic complete response after neoadjuvant chemoradiation. DESIGN: Retrospective cohort study. SETTING: National Cancer Database (2004-2017). PATIENTS: Patients with clinical stage 2 or 3 rectal adenocarcinoma who underwent neoadjuvant chemoradiation (50-50.4 Gy in 25-28 fractions) followed by total mesorectal excision with a pathologic complete response were included. INTERVENTION: Adjuvant chemotherapy. MAIN OUTCOME MEASURES: Overall survival. RESULTS: There were 20,518 patients and 2221 (11%) had a pathologic complete response after neoadjuvant chemoradiation. Of 2221 patients, 1441 (65%) did not receive adjuvant therapy and 780 (35%) did. Patients who received adjuvant therapy were more likely to be younger (median 58 vs 62 y), have private insurance (61% vs 49%), and have node-positive disease (57% vs 48%) (all p < 0.05). There were no differences in sex, race, Charlson-Deyo score, clinical T-stage, tumor size and differentiation, adequate lymphadenectomy (12 or more), or sphincter preservation between groups (all p > 0.05). Overall survival at 5, 10, and 14 years was significantly longer in the adjuvant group (93%, 85%, 83%, respectively) compared to patients who did not receive adjuvant therapy (87%, 67%, 51%, respectively) ( p < 0.001). In a subgroup analysis, adjuvant therapy was associated with improved survival in patients with clinical stage 2 and 3 rectal cancer ( p < 0.001). After adjusting for patient and tumor characteristics, omission of adjuvant chemotherapy was associated with significantly worse survival (HR 1.53, 95% 1.08-2.16). LIMITATIONS: Selection bias, unknown perioperative morbidity, chemotherapy regimen, recurrence status, and other unidentified factors limiting survival analysis. CONCLUSIONS: In patients with clinical stage 2 or 3 rectal cancer, adjuvant chemotherapy was associated with improved overall survival in patients achieving a pathological complete response after neoadjuvant chemoradiotherapy. See Video Abstract at http://links.lww.com/DCR/C139 . SOBREVIDA MEJORADA DESPUS DE LA TERAPIA ADYUVANTE EN PACIENTES CON CNCER DE RECTO LOCALMENTE AVANZADO CON RESPUESTA PATOLGICA COMPLETA: ANTECEDENTES:En los pacientes con cáncer de recto que logran una respuesta patológica completa después de la quimiorradioterapia neoadyuvante y la escisión total del mesorrecto, el beneficio de la terapia adyuvante no está claro.OBJETIVO:Evaluar el beneficio de la quimioterapia adyuvante en la sobrevida de los pacientes con cáncer de recto con una respuesta patológica completa después de la quimiorradioterapia neoadyuvante.DISEÑO:Estudio de cohorte retrospectivo.ESCENARIO:Base de Datos Nacional de Cáncer (2004-2017).PACIENTES:Pacientes con adenocarcinoma rectal en estadio clínico 2 ó 3 que se sometieron a quimiorradiación neoadyuvante (50-50,4 Gy en 25-28 fracciones) seguida de escisión mesorrectal total con una respuesta patológica completa.INTERVENCIÓN:Quimioterapia adyuvante.PRINCIPALES MEDIDAS DE RESULTADO:Sobrevida global.RESULTADOS:Hubo 20.518 pacientes y 2.221 (11%) tuvieron una respuesta patológica completa después de la quimiorradiación neoadyuvante. Entre estos 2221 pacientes, 1441 (65%) no recibieron terapia adyuvante y 780 (35%) sí. Los pacientes que recibieron terapia adyuvante tenían más probabilidades de ser más jóvenes (mediana de 58 frente a 62 años), tener un seguro privado (61% frente a 49%) y tener enfermedad con linfonodos positivos (57% frente a 48 %) (todos p < 0,05). No hubo diferencias en género, raza, puntuación de Charlson-Deyo, estadio T clínico, tamaño y diferenciación del tumor, linfadenectomía adecuada (≥12) o preservación del esfínter entre los grupos (todos p > 0,05). La sobrevida general a los 5, 10 y 14 años fue significativamente mayor en el grupo adyuvante (93%, 85%, 83%, respectivamente) en comparación con los pacientes que no recibieron terapia adyuvante (87%, 67%, 51% respectivamente) ( p < 0,001). En un análisis de subgrupos, la terapia adyuvante se asoció con una mejor sobrevida general en pacientes con cáncer de recto en estadio clínico 2 y 3 ( p < 0,001). Después de ajustar por las características del paciente y del tumor, la omisión de la quimioterapia adyuvante se asoció con una sobrevida global significativamente peor (HR 1,53, IC del 95%, 1,08-2,16).LIMITACIONES:Sesgo de selección; morbilidad perioperatoria desconocida, régimen de quimioterapia, estado de recurrencia y otros factores no identificados que limitan el análisis de sobrevida.CONCLUSIONES:En pacientes con cáncer de recto en estadio clínico 2 ó 3, la quimioterapia adyuvante se asoció con una mejor sobrevida general en pacientes que lograron una respuesta patológica completa después de la quimiorradioterapia neoadyuvante. Consulte Video Resumen en http://links.lww.com/DCR/C139 . (Traducción-Dr. Felipe Bellolio ).

Rectal Cancer: Clinical and Molecular Predictors of a Complete Response to Total Neoadjuvant Therapy.

BACKGROUND: Total neoadjuvant therapy in rectal cancer may increase pathological complete response rates, potentially allowing for a nonoperative approach. OBJECTIVE: The objective of this study was to identify patient and tumor characteristics that predict a complete response following total neoadjuvant therapy. DESIGN: This was a retrospective cohort study. SETTINGS: This study was conducted at a university-based National Cancer Institute-designated Comprehensive Cancer Center. PATIENTS: The patients include those with stage 2 or 3 rectal adenocarcinoma. INTERVENTIONS: Interventions included total neoadjuvant therapy, total mesorectal excision, and nonoperative management. MAIN OUTCOME MEASURES: Complete response was defined as either patients with a clinical complete response undergoing nonoperative management who remained cancer-free or patients undergoing surgery with a pathological complete response. RESULTS: Among 102 patients, median age was 54 years, 69% were male, median carcinoembryonic antigen level was 3.0 ng/mL, and the median distance of the tumor above the anorectal ring was 3 cm. Thirty-eight (37%) patients had a complete response, including 15 of 18 (83%) nonoperative patients who remained cancer free at a median of 22 months (range, 7-48 months) and 23 of 84 (27%) patients who underwent surgery and had a pathological complete response. The incomplete response group consisted of 61 patients who underwent initial surgery and 3 nonoperative patients with regrowth. There were no differences in gender, T-stage, or tumor location between groups. Younger age (median, 49 vs 55 years), normal carcinoembryonic antigen (71% vs 41%), clinical node-negative (24% vs 9%), smaller tumors (median 3.9 vs 5.4 cm), and wild-type p53 (79% vs 47%) and SMAD4 (100% vs 81%) were more likely to have a complete response (all p < 0.05). LIMITATIONS: This was a retrospective study with a small sample size. CONCLUSIONS: In patients with rectal cancer treated with total neoadjuvant therapy, more than one-third will achieve a pathological complete response or sustained clinical complete response with nonoperative management, making oncological resection superfluous in these patients. Smaller, wild-type p53 and SMAD4, and clinically node-negative cancers are predictive features of a complete response. See Video Abstract at http://links.lww.com/DCR/B889 . CNCER DE RECTO PREDICTORES CLNICOS Y MOLECULARES DE UNA RESPUESTA COMPLETA A LA TERAPIA NEOADYUVANTE TOTAL: ANTECEDENTES:La terapia neoadyuvante total en el cáncer de recto puede aumentar las tasas de respuesta patológica completa y permitir potencialmente un enfoque no quirúrgico.OBJETIVO:El objetivo fue identificar las características tanto del paciente y del tumor que logren predecir una respuesta completa después de la terapia neoadyuvante total.DISEÑO:Este fue un estudio de cohorte retrospectivo.AJUSTES:Este estudio se realizó en un Centro Integral de Cáncer designado por el Instituto Nacional del Cáncer con sede universitaria.PACIENTES:Los pacientes incluyen aquellos con adenocarcinoma de recto en estadio 2 o 3.INTERVENCIONES:Terapia neoadyuvante total, escisión total del mesorrecto, manejo conservador no quirúrgico.PRINCIPALES MEDIDAS DE RESULTADO:La respuesta completa se definió como pacientes con una respuesta clínica completa sometidos a tratamiento no quirúrgico que permanecieron libres de cáncer o pacientes sometidos a cirugía con una respuesta patológica completa.RESULTADOS:Entre 102 pacientes, la mediana de edad fue de 54 años, el 69% fueron hombres, la mediana del nivel de antígeno carcinoembrionario fue de 3.0 ng/ml y la mediana de la distancia del tumor por encima del anillo anorrectal fue de 3 cm. Thirty-eight (37%) pacientes tuvieron una respuesta completa que incluyó a 15 de 18 (83%) pacientes con manejo no operatorio y que permanecieron libres de cáncer en una mediana de 22 meses (rango 7- 48 meses) y 23 de 84 (27%) pacientes que fueron sometidos a cirugía y tuvieron una respuesta patológica completa. El grupo de respuesta incompleta consistió en 61 pacientes que fueron sometidos inicialmente a cirugía y 3 pacientes no quirúrgicos con recrecimiento. No se encontró diferencias de género, estadio T o ubicación del tumor entre los grupos. Edad más joven (mediana 49 frente a 55), antígeno carcinoembrionario normal (71% frente a 41%), ganglios clínicos negativos (24% frente a 9%), tumores más pequeños (mediana de 3,9 frente a 5,4 cm) y p53 de tipo salvaje (79 % vs 47%) y SMAD4 (100% vs 81%) tenían más probabilidades de tener una respuesta completa (todos p < 0,05).LIMITACIONES:Este fue un estudio retrospectivo y con un tamaño de muestra pequeño.CONCLUSIONES:En pacientes con cáncer de recto tratados con terapia neoadyuvante total, más de un tercio logrará una respuesta patológica completa o una respuesta clínica completa sostenida con manejo no operatorio, logrando que la resección oncológica sea superflua en estos pacientes. Los cánceres más pequeños, clínicamente con ganglios negativos, con p53 de tipo salvaje y SMAD4, son características predictoras de una respuesta completa. Consulte Video Resumen en http://links.lww.com/DCR/B889 . (Traducción-Dr. Osvaldo Gauto ).

High Complication Rate After Early Ileostomy Closure: Early Termination of the Short Versus Long Interval to Loop Ileostomy Reversal After Pouch Surgery Randomized Trial.

BACKGROUND: In patients with ulcerative colitis who undergo IPAA, a diverting ileostomy is used to diminish the severity of anastomotic complications. Typically, the ileostomy is closed after an interval of 2 to 4 months. The safety of earlier closure of the ileostomy after pouch surgery is unknown. OBJECTIVE: This study aimed to compare postoperative outcomes in patients randomly assigned to early (7-12 days) or late (≥8 weeks) ileostomy closure after ileal pouch construction. DESIGN: This was a multicenter, prospective randomized trial. SETTING: The study was conducted at colorectal surgical units at select United States hospitals. PATIENTS: Adults with ulcerative colitis who underwent 2- or 3-stage proctocolectomy with IPAA were included. MAIN OUTCOME MEASURES: The primary outcomes included Comprehensive Complication Index at 30 days after ileostomy closure. The secondary outcomes included complications, severe complications, reoperations, and readmissions within 30 days of ileostomy closure. RESULTS: The trial was stopped after interim analysis because of a high rate of complications after early ileostomy closure. Among 36 patients analyzed, 1 patient (3%) had unplanned proctectomy with end-ileostomy. Of the remaining 35 patients, 28 patients (80%) were clinically eligible for early closure and underwent radiologic assessment. There were 3 radiologic failures. Of the 25 remaining patients, 22 patients (88%) were randomly assigned to early closure (n = 10) or late closure (n = 12), and 3 patients were excluded. Median Comprehensive Complication Index was 14.8 (0-54) and 0 (0-23) after early and late closure (p = 0.02). One or more complications occurred in 7 patients (70%) after early closure and in 2 patients (17%) after late closure (p = 0.01)' and complications were severe in 3 patients (30%) after early closure and 0 patients after late closure (p = 0.04). Reoperation was required in 1 patient (10%) and 0 patients (p = 0.26) after early closure and readmission was required in 7 patients (70%) and 1 patient (8%) after late closure (p = 0.003). LIMITATIONS: This study was limited by early study closure and selection bias. CONCLUSIONS: Early closure of a diverting ileostomy in patients with ulcerative colitis who underwent IPAA is associated with an unacceptably high rate of complications. See Video Abstract at http://links.lww.com/DCR/C68. ALTA TASA DE COMPLICACIONES DESPUS DEL CIERRE PRECOZ DE LA ILEOSTOMA TERMINACIN TEMPRANA DEL ENSAYO ALEATORIZADO DE INTERVALO CORTO VERSUS LARGO PARA LA REVERSIN DE LA ILEOSTOMA EN ASA DESPUS DE LA CIRUGA DE RESERVORIO ILEAL: ANTECEDENTES:En los pacientes con colitis ulcerosa que se someten a una anastomosis del reservorio ileoanal, se utiliza una ileostomía de derivación para disminuir la gravedad de las complicaciones de la anastomosis. Por lo general, la ileostomía se cierra después de un intervalo de 2 a 4 meses. Se desconoce la seguridad del cierre más temprano de la ileostomía después de la cirugía de reservorio.OBJETIVO:Comparar los resultados posoperatorios en pacientes asignados al azar al cierre temprano (7-12 días) o tardío (≥ 8 semanas) de la ileostomía después de la construcción de un reservorio ileal.DISEÑO:Este fue un ensayo aleatorizado prospectivo multicéntrico.ESCENARIO:El estudio se realizó en unidades quirúrgicas colorrectales en hospitales seleccionados de los Estados Unidos.PACIENTES:Se incluyeron adultos con colitis ulcerosa que se sometieron a proctocolectomía en 2 o 3 tiempos con anastomosis ileoanal con reservorio.PRINCIPALES MEDIDAS DE RESULTADO:Los resultados primarios incluyeron el Índice Integral de Complicaciones a los 30 días después del cierre de la ileostomía. Los resultados secundarios incluyeron complicaciones, complicaciones graves, reoperaciones y readmisiones dentro de los 30 días posteriores al cierre de la ileostomía.RESULTADOS:El ensayo se detuvo después del análisis interino debido a una alta tasa de complicaciones después del cierre temprano de la ileostomía. Entre los 36 pacientes analizados, 1 (3%) tuvo una proctectomía no planificada con ileostomía terminal. De los 35 pacientes restantes, 28 (80%) fueron clínicamente elegibles para el cierre temprano y se sometieron a una evaluación radiológica. Hubo 3 fracasos radiológicos. De los 25 pacientes restantes, 22 (88 %) se asignaron al azar a cierre temprano (n = 10) o tardío (n = 12) y 3 fueron excluidos. La mediana del Índice Integral de Complicaciones fue de 14,8 (0-54) y 0 (0-23) después del cierre temprano y tardío (p = 0,02). Una o más complicaciones ocurrieron en 7 pacientes (70%) después del cierre temprano y 2 (17%) pacientes después del cierre tardío (p = 0,01) y fueron graves en 3 (30%) y 0 pacientes, respectivamente (p = 0,04). Requirieron reintervención en 1 (10%) y 0 (p = 0,26) y reingreso en 7 (70%) y 1 (8%) pacientes (p = 0,003).LIMITACIONES:Este estudio estuvo limitado por el cierre temprano del estudio; sesgo de selección.CONCLUSIONES:El cierre temprano de una ileostomía de derivación en pacientes con colitis ulcerosa con anastomosis de reservorio ileoanal se asocia con una tasa inaceptablemente alta de complicaciones. Consulte Video Resumen en http://links.lww.com/DCR/C68. (Traducción-Dr. Felipe Bellolio).

Monopolar stray energy in robotic surgery.

INTRODUCTION: Stray energy transfer from monopolar radiofrequency energy during laparoscopy can be potentially catastrophic. Robotic surgery is increasing in popularity; however, the risk of stray energy transfer during robotic surgery is unknown. The purpose of this study was to (1) quantify stray energy transfer using robotic instrumentation, (2) determine strategies to minimize the transfer of energy, and (3) compare robotic stray energy transfer to laparoscopy. METHODS: In a laparoscopic trainer, a monopolar instrument (L-hook) was activated with DaVinci Si (Intuitive, Sunnyvale, CA) robotic instruments. A camera and assistant grasper were inserted to mimic a minimally invasive cholecystectomy. During activation of the L-hook, the non-electric tips of the camera and grasper were placed adjacent to simulated tissue (saline-soaked sponge). The primary outcome was change in temperature from baseline (°C) measured nearest the tip of the non-electric instrument. RESULTS: Simulated tissue nearest the robotic grasper increased an average of 18.3 ± 5.8 °C; p < 0.001 from baseline. Tissue nearest the robotic camera tip increased (9.0 ± 2.1 °C; p < 0.001). Decreasing the power from 30 to 15 W (18.3 ± 5.8 vs. 2.6 ± 2.7 °C, p < 0.001) or using low-voltage cut mode (18.3 ± 5.8 vs. 3.1 ± 2.1 °C, p < 0.001) reduced stray energy transfer to the robotic grasper. Desiccating tissue, in contrast to open air activation, also significantly reduced stray energy transfer for the grasper (18.3 ± 5.8 vs. 0.15 ± 0.21 °C, p < 0.001) and camera (9.0 ± 2.1 vs. 0.24 ± 0.34 °C, p < 0.001). CONCLUSIONS: Stray energy transfer occurs during robotic surgery. The assistant grasper carries the highest risk for thermal injury. Similar to laparoscopy, stray energy transfer can be reduced by lowering the power setting, utilizing a low-voltage cut mode instead of coagulation mode and avoiding open air activation. These practical findings can aid surgeons performing robotic surgery to reduce injuries from stray energy.

Stray energy transfer in single-incision robotic surgery.

INTRODUCTION: Stray energy transfer from surgical monopolar radiofrequency energy instruments can cause unintended thermal injuries during laparoscopic surgery. Single-incision laparoscopic surgery transfers more stray energy than traditional laparoscopic surgery. There is paucity of published data concerning stray energy during single-incision robotic surgery. The purpose of this study was to quantify stray energy transfer during traditional, multiport robotic surgery (TRS) compared to single-incision robotic surgery (SIRS). METHODS: An in vivo porcine model was used to simulate a multiport or single-incision robotic cholecystectomy (DaVinci Si, Intuitive Surgical, Sunnyvale, CA). A 5 s, open air activation of the monopolar scissors was done on 30 W and 60 W coag mode (ForceTriad, Covidien-Medtronic, Boulder, CO) and Swift Coag effect 3, max power 180 W (VIO 300D, ERBE USA, Marietta, GA). Temperature of the tissue (°C) adjacent to the tip of the assistant grasper or the camera was measured with a thermal camera (E95, FLIR Systems, Wilsonville, OR) to quantify stray energy transfer. RESULTS: Stray energy transfer was greater in the SIRS setup compared to TRS setup at the assistant grasper (11.6 ± 3.3 °C vs. 8.4 ± 1.6 °C, p = 0.013). Reducing power from 60 to 30 W significantly reduced stray energy transfer in SIRS (15.3 ± 3.4 °C vs. 11.6 ± 3.3 °C, p = 0.023), but not significantly for TRS (9.4 ± 2.5 °C vs. 8.4 ± 1.6 °C, p = 0.278). The use of a constant voltage regulating generator also minimized stray energy transfer for both SIRS (0.7 ± 0.4 °C, p < 0.001) and TRS (0.7 ± 0.4 °C, p < 0.001). CONCLUSIONS: More stray energy transfer occurs during single-incision robotic surgery than multiport robotic surgery. Utilizing a constant voltage regulating generator minimized stray energy transfer for both setups. These data can be used to guide robotic surgeons in their use of safe, surgical energy.

Outcomes in rectal cancer patients undergoing laparoscopic or robotic low anterior resection compared to open: a propensity-matched analysis of the NCDB (2010-2015).

BACKGROUND: Minimally invasive resection of rectal cancer is controversial due to concerns of the oncologic efficacy and the difficulties of a laparoscopic total mesorectal excision (TME). METHODS: Using the National Cancer Database (NCDB), for the period 2010-2015, perioperative outcomes and overall survival (OS) in patients with rectal cancer who underwent laparoscopic or robotic low anterior resection (LLAR or RLAR) were compared to open LAR (OLAR) after propensity score matching. RESULTS: 26,047 patients underwent LAR: 4062 (16%) RLAR, 9236 (35%) LLAR, and 12,749 (49%) OLAR. Patient and clinical tumor characteristics were similar between groups after matching. The conversion rates among patients undergoing LLAR and RLAR were 15% and 8%, respectively. In matched OLAR and LLAR patients, longitudinal and circumferential resection margins (CRM) were positive in 5.4% and 3.2% (p < 0.001) and 5.5% and 4.1% (p < 0.001); length of stay was 6 and 5 days, (p < 0.001); readmission was required in 6.5% and 7.0% (p = 0.112); OS at 1, 3, and 5 years were 95.5%, 83.7%, and 72.0% and 95.9%, 86.3%, and 76.4%, respectively (p < 0.001). In matched OLAR and RLAR patients, longitudinal and CRM were positive in 5.4% and 3.2% (p < 0.001) and 5.5% and 3.9% (p < 0.001); length of stay was 6 and 5 days (p < 0.001); readmission was required in 6.1% and 7.9%, (p = 0.010); and OS at 1, 3, and 5 years were 96.2%, 86.5%, and 77.1% and 97.5%, 89.4%, and 79.7%, respectively (p = 0.001). CONCLUSIONS: In this national sample of propensity matched patients with rectal cancer who underwent open, laparoscopic, or robotic sphincter-saving rectal resection, only small differences in terms of resection margin status, length of stay, readmission, and overall survival were revealed. With acknowledgement of the limitations introduced by selection bias, our data indicate that each of the evaluated operative techniques results in acceptable outcomes for patients with rectal cancer.

Comparing Short-term and Oncologic Outcomes of Minimally Invasive Versus Open Pancreaticoduodenectomy Across Low and High Volume Centers.

OBJECTIVE: To compare short-term and oncologic outcomes of patients with cancer who underwent open pancreaticoduodenectomy (OPD) versus minimally invasive pancreaticoduodenectomy (MIPD) using the National Cancer Database. SUMMARY BACKGROUND DATA: MIPD, including laparoscopic and robotic approaches, has continued to gain acceptance despite prior reports of increased short-term mortality when compared with OPD. METHODS: Patients with pancreatic cancer diagnosed from 2010 to 2015 undergoing curative intent resection were selected from the National Cancer Database. Patients submitted to OPD were compared with those submitted to MIPD. Laparoscopic and robotic approaches were included in the MIPD cohort. The primary outcome was 90-day mortality; secondary outcomes included 30-day mortality, hospital length of stay, unplanned 30-day readmission, surgical margins, number of lymph nodes harvested, and receipt of adjuvant chemotherapy. Propensity score-weighted random effects logistic regression models were used to examine the adjusted association between surgical approach and the specified outcomes. RESULTS: Between 2010 and 2015, 22,013 patients underwent OPD or MIPD for pancreatic cancer and 3754 (17.1%) were performed minimally invasively. On multivariable analysis, there was no difference in 90-day mortality between MIPD and OPD (OR, 0.92; 95% CI, 0.75-1.14). Patients undergoing MIPD were less likely to stay in the hospital for a prolonged time (OR, 0.75; 95% CI, 0.68-0.82). 30-day mortality, unplanned readmissions, margins, lymph nodes harvested, and receipt of adjuvant chemotherapy were equivalent between groups. Regardless of surgical approach, patients operated on at high volume centers had reduced 90-day mortality. CONCLUSION: Patients selected to receive MIPD for cancer have equivalent short-term and oncologic outcomes, when compared with patients who undergo OPD.

Postbiopsy Pigmentation is Prognostic in Head and Neck Melanoma.

PURPOSE: To assess postbiopsy pigmentation (PBP) as a prognostic feature in patients with cutaneous head and neck (H&N) melanoma. METHODS: Retrospective review of patients undergoing sentinel lymph node biopsy (SLNB) for H&N melanoma (1998-2018). PBP was defined as visible remaining pigment at the scar or biopsy site that was documented on physical exam by both a medical oncologist and a surgeon at initial consultation. Variables associated with disease-free survival (DFS) and overall survival (OS) were analyzed using multivariable Cox proportional hazards models. RESULTS: Among 300 patients, 34.3% (n = 103) had PBP and 44.7% (n = 134) had microscopic residual disease on final pathology after wide local excision. Prognostic factors associated with DFS included advanced age, tumor depth, ulceration, PBP, and positive SLNB (p < 0.05). Patients with PBP fared worse than their counterparts without PBP in 5-year DFS [44.1% (31.1-56.3%) vs. 73.0% (64.1-80.0%); p < 0.001] and 5-year OS [65.0% (50.0-76.6%) vs. 83.6% (75.7-89.2%); p = 0.005]. After multivariable adjustment, PBP remained associated with shorter DFS [hazard ratio (HR) 1.72, 95% confidence interval (CI) 1.01-2.93; p = 0.047], but was not prognostic of OS. CONCLUSIONS: In patients with H&N melanoma, PBP is associated with significantly shorter DFS. Patients with PBP may warrant greater consideration for SLNB and closer postoperative surveillance.

Quality of Life Following Major Laparoscopic or Open Pancreatic Resection.

PURPOSE: This study was designed to compare quality of life (QoL) among patients who underwent open versus laparoscopic pancreatic resection, including distal pancreatectomy and pancreaticoduodenectomy, and to identify clinical characteristics that are associated with changes in QoL. METHODS: Quality of life (QoL) was assessed in patients undergoing pancreatic resection with the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire preoperatively and 2 weeks, 1, 3, and 6 months postoperatively. Multilevel regression modeling was used to determine the variability in each QoL domain within the first 2 weeks (postoperative period) and thereafter (recovery period). RESULTS: Among 159 patients, 60.4% underwent open and 39.6% underwent laparoscopic surgery. Physical, functional, hepatobiliary, and total QoL scores decreased in the postoperative period but returned to baseline levels by 6 months postoperatively. Emotional QoL improved from baseline by 2 weeks after surgery (p < 0.001) and social QoL improved from baseline by 3 months after surgery (p < 0.001). Emotional QoL was the only domain where significant differences were observed in QoL in the postoperative and recovery periods between patients who underwent open and laparoscopic pancreatic resection. Controlling for surgical approach, patients who experienced a grade III or IV complication experienced greater declines in physical, functional, hepatobiliary, and total QoL in the postoperative period. The negative impact of complications on QoL resolved by 6 months postoperatively. CONCLUSIONS: The impact of pancreatic resection on QoL was comparable between patients who underwent laparoscopic versus open pancreatic resection. Complications were strongly associated with changes in postoperative QoL, suggesting that performing a safe operation is the best approach for optimizing patient reported QoL.

Improved survival in rectal cancer patients who are treated with long-course versus short-course neoadjuvant radiotherapy: A propensity-matched analysis of the NCDB.

BACKGROUND: Randomized controlled trials have demonstrated comparable survival outcomes for short-course (SCRT) and long-course neoadjuvant radiotherapy (LCRT) in patients with rectal cancer. METHODS: Using the National Cancer Data Base (2004-2015), a propensity score was used to match 188 patients with rectal cancer receiving SCRT to 376 patients receiving LCRT. Perioperative, oncologic, and survival outcomes were compared. RESULTS: Patient and clinical tumor characteristics were similar between groups. Patients in the LCRT were more likely to undergo surgery (91% vs 85%; P = 0.03). The LCRT group were more likely to have tumor (T) (56% vs 43%) and nodal (N) (25% vs 19%) downstaging, and a complete pathological response (15% vs 6%) compared with the SCRT group (all P < 0.05). Length of stay (6 vs 8 days), 30-day (1% vs 5%) mortality, and 90-day mortality (1% vs 10%) were significantly lower in the LCRT group (all P < 0.05). After adjusting for patient and tumor-related characteristics, LCRT was associated with a 50% reduction in the risk of mortality compared with SCRT (hazard ratios, 0.50; 95% confidence interval, 0.35-0.70). CONCLUSIONS: In this analysis, LCRT was superior to SCRT in terms of tumor response to neoadjuvant therapy, perioperative mortality, and overall survival. These findings provide evidence for the use of LCRT when neoadjuvant therapy is indicated.

SPECT/CT Adds Distinct Lymph Node Basins and Influences Radiologic Findings and Surgical Approach for Sentinel Lymph Node Biopsy in Head and Neck Melanoma.

BACKGROUND: Planar lymphoscintigraphy (PL) has a lower detection rate of sentinel lymph nodes (SLNs) in head and neck melanoma compared with other sites. We assessed situations when single-photon emission computed tomography/computed tomography (SPECT/CT) identified nodes not seen by PL. We also evaluated the impact of SPECT/CT on surgical approach and oncologic outcomes. METHODS: Patients who underwent SLN biopsy (SLNB) for head and neck melanoma with PL and SPECT/CT between November 2011 and December 2016 were included. Surgeons and radiologists completed a real-time survey inquiring about the utility of SPECT/CT. Patients were divided into two groups: patients with nodal basins identified by both PL and SPECT/CT ('PL + SPECT/CT'), and patients in whom SPECT/CT identified additional nodal basins not seen on PL ('SPECT/CT only'). Patient demographics and long-term outcomes including follow-up duration, recurrence, and survival are described. RESULTS: In the PL + SPECT/CT group, 73 (61.9%) patients were included and 45 (38.1%) patients were included in the SPECT/CT-only group. SPECT/CT added 51 basins to those seen on PL, primarily in the supraclavicular region (43.1%). Eighteen patients had positive node(s) in the PL + SPECT/CT group compared with two patients in the SPECT/CT-only group. Surgeons reported that 81% of the time, SPECT/CT influenced the location of incision for SLNB. CONCLUSIONS: SPECT/CT influences the location of incision and contributes most to identification of nodes in the supraclavicular region. It also detects additional SLN basins when compared with PL. Further studies are necessary to determine when these additional basins require sampling.

Perioperative outcomes and survival following neoadjuvant stereotactic body radiation therapy (SBRT) versus intensity-modulated radiation therapy (IMRT) in pancreatic adenocarcinoma.

BACKGROUND AND OBJECTIVES: To compare outcomes in patients receiving neoadjuvant stereotactic body radiation therapy (SBRT) with those receiving intensity-modulated radiation therapy (IMRT) for pancreatic adenocarcinoma. METHODS: We analyzed patients receiving neoadjuvant SBRT for borderline resectable (BRPC) and locally advanced pancreatic cancer (LAPC) (2012-2016). Differences in baseline characteristics, perioperative outcomes, progression-free survival (PFS), and overall survival (OS) were compared. RESULTS: Seventy-five (82.4%) patients received SBRT and 16 (17.6%) received IMRT. There were no differences in surgical resection rates in the SBRT (n = 38, 50.7%) and IMRT (n = 11, 68.8%) groups (P = 0.188). Among resected patients, there was no difference in postoperative outcomes or pathologic outcomes including lymph node status, margin status, lymphovascular and perineural invasion, or pathologic response to neoadjuvant treatment (P > 0.05). Among all patients, median PFS and OS were 9.9 and 23.5 months in the SBRT group, respectively, and 15.3 and 21.8 months in the IMRT group, respectively (P > 0.05). Similarly, there was no difference in PFS or OS between groups when stratified by BRPC, LAPC, and surgically resected patients (P > 0.05). CONCLUSIONS: In the neoadjuvant setting, SBRT and IMRT appear to have similar rates of resection, perioperative outcomes, and survival outcomes, but additional studies with increased sample size and longer follow up are needed.

Laparoscopic pancreaticoduodenectomy: changing the management of ampullary neoplasms.

BACKGROUND: The purpose of this study is to present the largest reported series comparing open pancreaticoduodenectomy (OPD) to total laparoscopic pancreaticoduodenectomy (TLPD) in patients with ampullary neoplasms. METHODS: Patients undergoing OPD or TLPD for ampullary neoplasms from June 2012 to August 2016 were retrospectively identified. Perioperative outcomes were compared using a Wilcoxon rank-sum test, Student's t test, and Chi square analysis where appropriate. Kaplan-Meier estimates for progression-free survival (PFS) and overall survival (OS) were compared between the groups using the log-rank test. RESULTS: We identified 47 patients with ampullary neoplasms (adenocarcinoma n = 36, neuroendocrine tumor n = 7, undifferentiated n = 1, adenoma n = 3) undergoing OPD (n = 25) and TLPD (n = 22). The proportion of patients being offered TLPD has progressively increased every year over 5 years: 0% (2012) to 50% (2015). There were no differences in baseline variables between the two groups. TLPD was associated with less blood loss (300 vs. 500 mL, p < 0.001) and shorter operative times (314 vs. 359 min, p = 0.024). No patient required conversion to an open procedure and there were no perioperative deaths in either group. TLPD was associated with lower rates of intra-abdominal abscess (0 vs. 16.0%, p = 0.049), but there were no differences in rates of pancreatic fistula, bile leak, delayed gastric emptying, wound infection, length of stay, and readmission (all p > 0.05). Among patients with adenocarcinoma, there was no difference in pathological features between the two groups (p > 0.05) and all patients had negative margins. At a median follow up of 25 months, there was no difference in PFS or OS between the two groups. CONCLUSIONS: TLPD in patients with ampullary neoplasms results in improved perioperative outcomes while having equivalent short and long-term oncologic outcomes compared to the traditional open approach.

Comparison of laparoscopic to open pancreaticoduodenectomy in elderly patients with pancreatic adenocarcinoma.

INTRODUCTION: The purpose of the study is to compare perioperative and survival outcomes in elderly patients undergoing laparoscopic pancreaticoduodenectomy (LPD) to those undergoing open pancreaticoduodenectomy (OPD). METHODS: Patients aged ≥ 75 years with pancreatic adenocarcinoma undergoing LPD or OPD were identified from the NCDB (2010-2013). Baseline characteristics and perioperative outcomes were compared using a χ 2 and Student's t test. The Kaplan-Meier method was used to generate survival curves, and differences were tested using a log-rank test. A multivariate cox proportional hazard model was applied to estimate the hazard ratio (HR) of LPD on overall survival (OS). RESULTS: We identified 1768 patients aged ≥ 75 years who underwent LPD (n = 248, 14.0%) or OPD (n = 1520, 86.0%). The majority of patients in the LPD group had their surgery at facilities performing less than 5 LPDs per year (n = 165, 66.5%). 90-day mortality was significantly lower in the LPD compared to the OPD (7.2 vs. 12.2%, p = 0.049). The laparoscopic conversion rate was 30% (n = 74) and was associated with higher readmission rates (13.5 vs. 8.1%), 30-day mortality (8.0 vs. 3.8%), and 90-day mortality (10.4 vs. 6.0%), but these did not reach statistical significance. Median OS was significantly longer in the LPD group (19.8 vs. 15.6 months, p = 0.022). After adjusting for patient and tumor-related characteristics, there was a trend towards improved survival in the LPD group (HR 0.85, 95% CI 0.69-1.03). CONCLUSION: The vast majority of the NCDB participating facilities perform less than 5 LPD cases per year, which was associated with an increased risk of perioperative mortality. Overall 90-day mortality was significantly lower in the LPD group and there was a trend towards improved OS in the LPD group compared to the OPD group after adjusting for patient and tumor-related characteristics. Studies with increased sample size and longer follow-up are needed before definitive conclusions can be made.

Perioperative and Survival Outcomes Following Neoadjuvant FOLFIRINOX versus Gemcitabine Abraxane in Patients with Pancreatic Adenocarcinoma.

CONTEXT: Neoadjuvant chemotherapy is increasingly used in borderline resectable and locally advanced pancreatic cancer to facilitate surgical resection. OBJECTIVE: To compare progression free survival and overall survival in patients receiving neoadjuvant FOLFIRINOX with those receiving gemcitabine/abraxane. DESIGN: Retrospective cohort study. SETTING: University of Colorado Hospital from 2012-2016. PARTICIPANTS: Patients with pancreatic adenocarcinoma. INTERVENTIONS: Neoadjuvant FOLFIRINOX or gemcitabine/abraxane. OUTCOME MEASURES: Perioperative outcomes, progression free survival, and overall survival were compared between groups. A multivariate Cox proportional hazard model was applied to evaluate survival outcomes. RESULTS: We identified 120 patients: 83 (69.2%) FOLFIRINOX and 37 (30.8%) gemcitabine/abraxane. The FOLIFRINOX group was younger and had a lower ECOG performance status (p<0.05). Patients in the FOLFIRINOX group were more likely to undergo surgical resection compared to gemcitabine/abraxane (66.3% vs. 32.4%, p=0.002). Among all patients, median follow up was 16.9 months and FOLFIRINOX was associated with improved PFS (15.3 vs. 8.2 months, p=0.006), but not overall survival (23.5 vs. 18.7 months, p=0.228). In these patients, insulin-dependent diabetes was associated with a worse progression free survival and overall survival and surgical resection was protective. Among surgically resected patients, median follow up was 21.1 months and there was no difference in progression free survival (19.5 vs. 15.1 months) or overall survival (27.4 vs. 19.8 months) between the FOLFIRINOX and gemcitabine/abraxane groups, respectively (p>0.05). Insulin-dependent diabetes and a poor-to-moderate pathologic response was associated with worse progression free survival and overall survival. CONCLUSION: Neoadjuvant FOLFIRINOX may improve progression free survival by increasing the proportion of patients undergoing surgical resection. Improved understanding of the role for selection bias and longer follow up are needed to better define the impact of neoadjuvant FOLFIRINOX on overall survival.

Laparoscopic Spleen-Preserving Total Pancreatectomy for a Main-Duct Intraductal Papillary Mucinous Neoplasm.

INTRODUCTION: Main-duct intraductal papillary mucinous neoplasms of the pancreas (M-IPMN) are potentially malignant cystic neoplasms that can degenerate into invasive malignancy in 43 % of cases.1 Although laparoscopic pancreaticoduodenectomy and distal pancreatectomy have been previously described for the management of pancreatic neoplasms, laparoscopic total pancreatectomy is rarely described. We present a video demonstrating a laparoscopic spleen-preserving total pancreatectomy in a patient with M-IPMN. CASE PRESENTATION: A healthy 66-year-old male was diagnosed with recurrent pancreatitis. A computed tomography of the abdomen demonstrated a diffusely dilated pancreatic duct (10 mm) and a 5 mm mural nodule in the neck of the pancreas. Endoscopic retrograde cholangiopancreatography demonstrated a 'fish mouth' appearance at the major papilla, with a villous mass (15 mm) in the pancreatic head. Biopsy was consistent with M-IPMN, and tumor markers were normal. RESULTS: A spleen-preserving laparoscopic total pancreatectomy was performed over a period of 270 min, with 150 cc of blood loss without complications. The patient was admitted to the intensive care unit for continuous insulin infusion. On postoperative day (POD) 1, his nasogastric tube was discontinued, transitioned to subcutaneous insulin injections, and transferred to the floor. He tolerated a diabetic diet on POD 4. His surgical drain had minimal output with no evidence of a bile leak, and was discontinued on POD 5. The patient's hospital course was uncomplicated and he was discharged home on POD 7. Pathology demonstrated IPMN with moderate dysplasia. CONCLUSION: Laparoscopic total pancreatectomy can be safely performed in patients with M-IPMN. This video presentation describes the technique we used for this procedure.

Implications of Sentinel Lymph Node Drainage to Multiple Basins in Head and Neck Melanoma.

BACKGROUND: Sentinel lymph node biopsy (SLNB) for head and neck melanoma is challenging due to unpredictable drainage. We sought to determine the frequency of drainage to multiple lymphatic basins and asked if this was associated with prognosis in a large, single-center cohort. METHODS: We queried patients diagnosed with head and neck melanomas who had a SLNB performed from January 1998 to April 2016. Demographic and clinical characteristics were compared using Student's t test, Pearson chi-square analysis, log-rank test, Wilcoxon-Mann-Whitney test, and Kaplan-Meier curves. RESULTS: We identified 269 patients with head and neck melanoma that had SLNBs performed in the following locations: 223 neck, 92 parotid/preauricular, 29 occipital/posterior auricular, 1 axilla. There were 68 (25%) patients who had drainage to multiple basins. These patients were similar to those with single basin drainage in age, gender distribution, Breslow depth, and percent with a positive SLNB (all p > 0.05). Fewer patients with drainage to multiple basins had a completion lymph node dissection (CLND, p = 0.03). A trend toward increased 3-year locoregional recurrence was seen for patients with drainage to multiple basins in univariate analysis (27% vs. 18%, p = 0.10) but was lost in multivariate analysis (p = 0.49), possibly because of higher recurrence rates in patients with positive nodes but no CLND (p = 0.02). No difference was detected for distant recurrence or overall survival based on SLN drainage. CONCLUSIONS: Head and neck melanoma SLNB drainage to multiple basins is common. Drainage to multiple basins does not seem to be associated with increased sentinel lymph node positivity, locoregional recurrence, distant recurrence, or survival.

Morbidity of endovascular abdominal aortic aneurysm repair is directly related to diameter.

OBJECTIVE: Previous randomized controlled trials have defined specific size thresholds to guide surgical decision-making in patients presenting with an abdominal aortic aneurysm (AAA). With recent advances in endovascular techniques, the anatomic considerations of AAA repair are rapidly changing. Our specific aims were to evaluate the most recent national population data to compare anatomic differences and perioperative outcomes in patients with AAA. METHODS: The American College of Surgeons National Surgical Quality Improvement Program was queried from 2011 to 2015 using the targeted vascular public use file. Patients with AAA undergoing elective open or endovascular repair were included. Risk factors and outcomes were stratified by size and divided into quartiles for categorical comparison. A logistic regression model was used to compare the impact of size on morbidity and mortality with each technique. A risk adjustment model used all preoperative criteria to generate observed and expected values for open and endovascular repair. RESULTS: There were 10,026 patients who underwent elective AAA repair, 8182 (81.6%) endovascular and 1844 (18.4%) open. Repairs were divided into density quartiles for a logistic analysis: smallest quartile, 3.5 to 5 cm; second quartile, 5.01 to 5.5 cm; third quartile, 5.51 to 6.2 cm; and largest quartile, >6.2 cm. Patients with larger aneurysms (>6.2 cm) were more likely to be male, to have a dependent functional status, and to have increased blood urea nitrogen concentration and American Society of Anesthesiologists score (P < .05). Larger aneurysms had longer operative time (162 vs 135 minutes) and greater extension toward the renal and iliac vessels (all P < .05). Risk adjustment revealed an observed/expected morbidity plot that favored endovascular repair throughout the size range but confirmed lack of size effect within the open repair category. The adjusted increase in morbidity with endovascular repair is 9.7% per centimeter increase in size of AAA. These trends remained true with an infrarenal subgroup analysis. CONCLUSIONS: Patients with a larger AAA have comorbidities and anatomic factors associated with a more difficult repair. The higher morbidity seen with larger aneurysms represents both anatomic and patient factors but seems to have a greater impact on endovascular repairs. However, endovascular repair still results in fewer near-term complications than open repair across all size strata.

Hand-to-hand coupling and strategies to minimize unintentional energy transfer during laparoscopic surgery.

BACKGROUND: Energy-based devices are used in nearly every laparoscopic operation. Radiofrequency energy can transfer to nearby instruments via antenna and capacitive coupling without direct contact. Previous studies have described inadvertent energy transfer through bundled cords and nonelectrically active wires. The purpose of this study was to describe a new mechanism of stray energy transfer from the monopolar instrument through the operating surgeon to the laparoscopic telescope and propose practical measures to decrease the risk of injury. METHODS: Radiofrequency energy was delivered to a laparoscopic L-hook (monopolar "bovie"), an advanced bipolar device, and an ultrasonic device in a laparoscopic simulator. The tip of a 10-mm telescope was placed adjacent but not touching bovine liver in a standard four-port laparoscopic cholecystectomy setup. Temperature increase was measured as tissue temperature from baseline nearest the tip of the telescope which was never in contact with the energy-based device after a 5-s open-air activation. RESULTS: The monopolar L-hook increased tissue temperature adjacent to the camera/telescope tip by 47 ± 8°C from baseline (P < 0.001). By having an assistant surgeon hold the camera/telescope (rather than one surgeon holding both the active electrode and the camera/telescope), temperature change was reduced to 26 ± 7°C (P < 0.001). Alternative energy devices significantly reduced temperature change in comparison to the monopolar instrument (47 ± 8°C) for both the advanced bipolar (1.2 ± 0.5°C; P < 0.001) and ultrasonic (0.6 ± 0.3°C; P < 0.001) devices. CONCLUSIONS: Stray energy transfers from the monopolar "bovie" instrument through the operating surgeon to standard electrically inactive laparoscopic instruments. Hand-to-hand coupling describes a new form of capacitive coupling where the surgeon's body acts as an electrical conductor to transmit energy. Strategies to reduce stray energy transfer include avoiding the same surgeon holding the active electrode and laparoscopic camera or using alternative energy devices.

Impact of neoadjuvant chemoradiation on perioperative outcomes in patients with rectal cancer.

BACKGROUND AND OBJECTIVES: Neoadjuvant chemoradiation for rectal cancer is associated with lower local recurrence rates. The objective of this study is to assess the impact of neoadjuvant therapy on perioperative complications in patients with rectal cancer. METHODS: Using the ACS-NSQIP database (2005-2012), a propensity score was used to match 3592 patients with rectal cancer receiving neoadjuvant therapy to 3592 patients undergoing surgery alone. The association between neoadjuvant chemoradiation and perioperative outcomes was evaluated. RESULTS: Among all patients, overall morbidity was significantly higher in the neoadjuvant therapy group (n = 1170, 29.9%) compared to the surgery alone (n = 2350, 26.4%; P < 0.0001), but 30-day mortality was lower in the neoadjuvant group (n = 27, 0.7%) compared to the surgery alone group (n = 112, 1.3%; P = 0.0043). However, in propensity-matched patients, there was no difference in overall morbidity (OR 0.912, 95% CI 0.825-1.008) or 30-day mortality (OR 0.639, 95% CI 0.38-1.05). Overall morbidity and 30-day mortality were 29.3% (n = 1054) and 0.7% (n = 25) in the neoadjuvant group, respectively, compared to 31.3% (n = 1124) and 1.1% (n = 39) in the surgery alone group, respectively. CONCLUSION: Patients with newly diagnosed rectal cancer could be evaluated for neoadjuvant therapy prior to surgical resection without the fear of upfront therapy causing a significant increase in perioperative complications.