RESUMEN
OBJECTIVE: The study objective was to determine the clinical utility of pafolacianine, a folate receptor-targeted fluorescent agent, in revealing by intraoperative molecular imaging folate receptor α positive cancers in the lung and narrow surgical margins that may otherwise be undetected with conventional visualization. METHODS: In this Phase 3, 12-center trial, 112 patients with suspected or biopsy-confirmed cancer in the lung scheduled for sublobar pulmonary resection were administered intravenous pafolacianine within 24 hours before surgery. Participants were randomly assigned to surgery with or without intraoperative molecular imaging (10:1 ratio). The primary end point was the proportion of participants with a clinically significant event, reflecting a meaningful change in the surgical operation. RESULTS: No drug-related serious adverse events occurred. One or more clinically significant event occurred in 53% of evaluated participants compared with a prespecified limit of 10% (P < .0001). In 38 participants, at least 1 event was a margin 10 mm or less from the resected primary nodule (38%, 95% confidence interval, 28.5-48.3), 32 being confirmed by histopathology. In 19 subjects (19%, 95% confidence interval, 11.8-28.1), intraoperative molecular imaging located the primary nodule that the surgeon could not locate with white light and palpation. Intraoperative molecular imaging revealed 10 occult synchronous malignant lesions in 8 subjects (8%, 95% confidence interval, 3.5-15.2) undetected using white light. Most (73%) intraoperative molecular imaging-discovered synchronous malignant lesions were outside the planned resection field. A change in the overall scope of surgical procedure occurred for 29 of the subjects (22 increase, 7 decrease). CONCLUSIONS: Intraoperative molecular imaging with pafolacianine improves surgical outcomes by identifying occult tumors and close surgical margins.
Asunto(s)
Neoplasias Pulmonares , Márgenes de Escisión , Humanos , Pulmón/patología , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/patología , Imagen Molecular/métodosRESUMEN
OBJECTIVE: Robotic-assisted minimally invasive esophagectomy accounts for a growing proportion of esophagectomies, potentially due to improved technical capabilities simplifying the challenging aspects of standard minimally invasive esophagectomy. However, there is limited evidence directly comparing both operations. The objective is to evaluate the short-term and long-term outcomes of robotic-assisted minimally invasive esophagectomy in comparison with the minimally invasive esophagectomy approach for patients with esophageal cancer over a 7-year period at a high-volume center. The primary end points of this study were overall survival and disease-free survival. Secondary end points included operation-specific morbidity, lymph node yield, readmission status, and in-hospital, 30-day, and 90-day mortality. METHODS: Patients who underwent robotic-assisted minimally invasive esophagectomy or standard minimally invasive esophagectomy over a 7-year period were identified from a prospectively maintained database. Inclusion criteria were patients with stage I to III disease, operations performed past the learning curve, and no evidence of scleroderma or cirrhosis. A 1:3 propensity match (robotic-assisted minimally invasive esophagectomy:minimally invasive esophagectomy) for multiple clinical covariates was performed to identify the final study cohort. Perioperative outcomes were compared between the 2 operations. RESULTS: A total of 734 patients undergoing minimally invasive esophagectomy (n = 630) or robotic-assisted minimally invasive esophagectomy (n = 104) for esophageal cancer were identified. After exclusions and matching, a total cohort of 246 patients undergoing robotic-assisted minimally invasive esophagectomy (n = 65) or minimally invasive esophagectomy (n = 181) were identified. There was no difference in overall survival (P = .69) or disease-free survival (P = .70). There were no significant differences in rates of major morbidity: pneumonia (17% vs 17%, P = .34), chylothorax (8% vs 9%, P = .95), recurrent laryngeal nerve injury (0% vs 1.5%, P = 1), anastomotic leak (5% vs 4%, P = .49), intraoperative complications (9% vs 8%, P = .73), or complete resection rates (99% vs 96%, P = .68). There was no difference in in-hospital (P = .89), 30-day (P = .66) or 90-day mortality (P = .73) between both cohorts. The robotic-assisted minimally invasive esophagectomy cohort yielded a higher median lymph node harvest in comparison with the minimally invasive esophagectomy cohort (32 vs 29, P = .02). CONCLUSIONS: Robotic-assisted minimally invasive esophagectomy may improve lymphadenectomy in patients undergoing esophagectomy for cancer. Minimally invasive esophagectomy and robotic-assisted minimally invasive esophagectomy are otherwise associated with similar mortality, morbidity, and perioperative outcomes. Further prospective study is required to investigate whether improved lymph node resection may translate to improved oncologic outcomes.
Asunto(s)
Neoplasias Esofágicas , Procedimientos Quirúrgicos Robotizados , Humanos , Esofagectomía/efectos adversos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Resultado del Tratamiento , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Neoplasias Esofágicas/patología , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Estudios RetrospectivosRESUMEN
OBJECTIVE: The aim of the study was to determine whether prolonged air leak (PAL) is associated with postoperative morbidity and mortality following pulmonary resection after adjusting for differences in baseline characteristics using propensity score analysis. SUMMARY BACKGROUND DATA: Patients with PAL after lung resection have worse outcomes than those without PAL. However, adverse postoperative outcomes may also be secondary to baseline risk factors, such as poor lung function. METHODS: Patients who underwent pulmonary resection for lung cancer/nodules (1/2009-6/2014) were stratified by the presence of PAL [n = 183 with/1950 without; defined as >5 d postoperative air leak; n = 189 (8.3%)]; probability estimates for propensity for PAL from 31 pretreatment/intraoperative variables were generated. Inverse probability-of-treatment weights were applied and outcomes assessed with logistic regression. RESULTS: Standardized bias between groups was significantly reduced after propensity weighting (mean = 0.18 before vs 0.08 after, P < 0.01). After propensity weighting, PAL was associated with increased odds of empyema (OR = 8.5; P < 0.001), requirement for additional chest tubes for pneumothorax (OR = 7.5; P < 0.001), blood transfusion (OR = 2; P = 0.03), pulmonary complications (OR = 4; P < 0.001), unexpected return to operating room (OR = 4; P < 0.001), and 30-day readmission (OR = 2; P = 0.009). Among other complications, odds of cardiac complications (P = 0.493), unexpected ICU admission (P = 0.156), and 30-day mortality (P = 0.270) did not differ. Length of hospital stay was prolonged (5.04 d relative effect, 95% confidence interval, 3.77-6.30; P < 0.001). CONCLUSIONS: Pulmonary complications, readmission, and delayed hospital discharge are directly attributable to having a PAL, whereas cardiac complications, unexpected admission to the ICU, and 30-day mortality are not after propensity score adjustment.
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Tiempo de Internación/estadística & datos numéricos , Readmisión del Paciente/estadística & datos numéricos , Neumonectomía/efectos adversos , Neumotórax/complicaciones , Neumotórax/etiología , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Alta del Paciente , Puntaje de Propensión , Medición de Riesgo , Factores de TiempoRESUMEN
OBJECTIVE: A recent meta-analysis of 3 randomized controlled trials reported reduced incidence and severity of postesophagectomy anastomotic dehiscence with anastomotic omentoplasty. Unfortunately, these trials excluded neoadjuvant patients who received chemoradiation. We aimed to determine whether anastomotic omentoplasty was associated with differential postesophagectomy anastomotic complications after neoadjuvant chemoradiotherapy. METHODS: Data for patients who underwent minimally invasive esophagectomy following neoadjuvant chemoradiotherapy were abstracted (n = 245; 2001-2016; omentoplasty = 147 [60%]). Propensity for omentoplasty was estimated on 21 pretreatment variables, using augmented inverse probability of treatment weights, and used to determine the adjusted proportion of adverse anastomotic outcomes, major morbidity, and 30-day/in-hospital mortality. RESULTS: Overall, anastomotic leak rate was 15%; leak-associated mortality was 13% (n = 5 out of 37). Leak rates (omentoplasty n = 24 [16%] vs no omentoplasty n = 13 [13%]; P = .512) and incidence of any major complications (48% vs 48%; P = .958) were similar. Leaks requiring surgical intervention occurred in 12 patients (5% vs 5%; P = .904). Propensity weighting achieved excellent balance across all 21 pretreatment variables (before weighting, standardized differences ranged from -0.23 to 0.35; postweighting standardized differences ranged from -0.09 to 0.07). In propensity-weighted data, omentoplasty was not associated with differential adjusted risk of anastomotic leak (13.2% vs 14.3%; P = .83), major morbidity (27.9% vs 32.6%; P = .44), or mortality (6.7% vs 4.8%; P = .61). CONCLUSIONS: Within the limits of our sample size and statistical approach, our study failed to find evidence that anastomotic omentoplasty during esophagectomy after neoadjuvant chemoradiation reduced anastomotic leak rate or need for leak-related reoperation.
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Fuga Anastomótica , Neoplasias Esofágicas/terapia , Esofagectomía/efectos adversos , Epiplón/cirugía , Anciano , Fuga Anastomótica/mortalidad , Fuga Anastomótica/cirugía , Quimioradioterapia/efectos adversos , Quimioradioterapia/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante/efectos adversos , Terapia Neoadyuvante/estadística & datos numéricos , Puntaje de Propensión , Estudios Prospectivos , Procedimientos de Cirugía PlásticaRESUMEN
BACKGROUND: Segmentectomy for well-selected early stage non-small-cell lung carcinoma (NSCLC) has been shown to have similar oncologic outcomes and survival to lobectomy. However, these data are based on the presumption that the disease is node negative. Few data exist regarding the risk factors for and the outcomes of patients with disease treated with segmentectomy that is found to be node positive. We sought to determine the risk factors for and outcomes of clinical stage I NSCLC patients who are treated with segmentectomy but are determined to be node positive. PATIENTS AND METHODS: We queried patients with clinical stage I NSCLC ≤ 3 cm within the National Cancer Data Base between 2004 and 2014 who were treated with segmentectomy or lobectomy and found to have positive nodes. Kaplan-Meier curves with log-rank tests were used to compare overall survival (OS) between segmentectomy and lobectomy. For comparison only, segmentectomy patients with pathologically node-negative disease were identified to determine predictors of node positivity after segmentectomy via multivariable logistic regression. RESULTS: A total of 4556 patients with node-positive disease were identified, comprising 115 segmentectomy patients and 4441 lobectomy patients. Multivariable analysis identified increasing tumor size, squamous-cell histology, and increasing number lymph nodes sampled as significant predictors of node positivity after segmentectomy. There was no difference in OS between segmentectomy and lobectomy, with 3-year OS rates of 66.3% and 68.1%, respectively (P = .723). CONCLUSION: There are discrete risk factors for discovering positive nodes after segmentectomy. Segmentectomy is associated with similar OS compared to lobectomy for clinical stage I NSCLC found to be node positive.
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Carcinoma de Pulmón de Células no Pequeñas/cirugía , Neoplasias Pulmonares/cirugía , Ganglios Linfáticos/patología , Neumonectomía/métodos , Anciano , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Carcinoma de Pulmón de Células no Pequeñas/patología , Femenino , Humanos , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Ganglios Linfáticos/cirugía , Metástasis Linfática , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Factores de Riesgo , Análisis de Supervivencia , Resultado del Tratamiento , Carga TumoralRESUMEN
OBJECTIVE: Prolonged air leak increases costs and worsens outcomes after pulmonary resection. We aimed to develop a clinical prediction tool for prolonged air leak using pretreatment and intraoperative variables. METHODS: Patients who underwent pulmonary resection for lung cancer/nodules (from January 2009 to June 2014) were stratified by prolonged parenchymal air leak (>5 days). Using backward stepwise logistic regression with bootstrap resampling for internal validation, candidate variables were identified and a nomogram risk calculator was developed. RESULTS: A total of 2317 patients underwent pulmonary resection for lung cancer/nodules. Prolonged air leak (8.6%, n = 200) was associated with significantly longer hospital stay (median 10 vs 4 days; P < .001). Final model variables associated with increased risk included low percent forced expiratory volume in 1 second, smoking history, bilobectomy, higher annual surgeon caseload, previous chest surgery, Zubrod score >2, and interaction terms for right-sided thoracotomy and wedge resection by thoracotomy. Wedge resection, higher body mass index, and unmeasured percent forced expiratory volume in 1 second were protective. Derived nomogram discriminatory accuracy was 76% (95% confidence interval [CI], 0.72-0.79) and facilitated patient stratification into low-, intermediate- and high-risk groups with monotonic increase in observed prolonged air leaks (2.0%, 8.9%, and 19.2%, respectively; P < .001). Patients at intermediate and high risk were 4.80 times (95% CI, 2.86-8.07) and 11.86 times (95% CI, 7.21-19.52) more likely to have prolonged air leak compared with patients at low risk. CONCLUSIONS: Using readily available candidate variables, our nomogram predicts increasing risk of prolonged air leak with good discriminatory ability. Risk stratification can support surgical decision making, and help initiate proactive, patient-specific surgical management.