Factors associated with access and approach to esophagectomy for cancer: a National Cancer Database study.

BACKGROUND: Minimally invasive esophagectomy (MIE) for esophageal cancer has been associated with decreased pain, less blood loss, and shorter hospital stay with comparable survival to open surgery. To date, there is minimal information regarding what factors are associated with access to MIE. METHODS: The National Cancer Database (NCDB) was used to compare rates of MIE (either robotic or laparoscopic) and open esophagectomy (OE) by demographic and clinical factors. Continuous variables were compared using a linear trend test, and categorical variables were compared using Mantel-Haenszel tests. Binomial regression was performed to examine significant factors after adjusting for confounding variables. RESULTS: There were 18,366 patients included in the analysis. Of all esophagectomies performed in the US, 49% were performed by OE and 51% were performed by MIE. Patients who had undergone MIE were more likely to live in the Eastern US as compared with the Midwest [odds ratio (OR) 1.72; 95% confidence interval (CI) 1.58, 1.88] or the South (OR 1.31; 95% CI 1.19, 1.44). They were also more likely to be treated at an academic center (OR 1.64; 95% CI 1.53, 1.75) rather than a community hospital, and to be of White race as compared with Asian race (OR 1.46; 95% CI 1.10, 1.92). There was not a significant difference in the rates of MIE between White and Black patients (OR 1.12; 95% CI 0.96, 1.32). MIE was more likely with each passing year, and higher TNM stages of cancer were less likely to be treated with MIE (P < 0.001 for all). CONCLUSION: While MIE is evolving, OE is still considered standard of care with robotic approaches representing a minority of MIE. While there are several factors associated with access to MIE, including race, facility type and geographic location, these factors should be further explored to help increase access to MIE.

The effect of enhanced recovery after minimally invasive esophagectomy: a randomized controlled trial.

BACKGROUND: The purpose of this randomized controlled trial was to determine if enhanced recovery after surgery (ERAS) would improve outcomes for three-stage minimally invasive esophagectomy (MIE). METHODS: Patients with esophageal cancer undergoing MIE between March 2016 and August 2018 were consecutively enrolled, and were randomly divided into 2 groups: ERAS+group that received a guideline-based ERAS protocol, and ERAS- group that received standard care. The primary endpoint was morbidity after MIE. The secondary endpoints were the length of stay (LOS) and time to ambulation after the surgery. The perioperative results including the Surgical Apgar Score (SAS) and Visualized Analgesia Score (VAS) were also collected and compared. RESULTS: A total of 60 patients in the ERAS+ group and 58 patients in the ERAS- group were included. Postoperatively, lower morbidity and pulmonary complication rate were recorded in the ERAS+ group (33.3% vs. 51.7%; p = 0.04, 16.7% vs. 32.8%; p = 0.04), while the incidence of anastomotic leakage remained comparable (11.7% vs. 15.5%; p = 0.54). There was an earlier ambulation (3 [2-3] days vs. 3 [3-4] days, p = 0.001), but comparable LOS (10 [9-11.25] days vs. 10 [9-13] days; p = 0.165) recorded in ERAS+ group. The ERAS protocol led to close scores in both SAS (7.80 ± 1.03 vs. 8.07 ± 0.89, p = 0.21) and VAS (1.74 ± 0.85 vs. 1.78 ± 1.06, p = 0.84). CONCLUSIONS: Implementation of an ERAS protocol for patients undergoing MIE resulted in earlier ambulation and lower pulmonary complications, without a change in anastomotic leakage or length of hospital stay. Further studies on minimizing leakage should be addressed in ERAS for MIE.

Radiofrequency ablation of stage IA non-small cell lung cancer in medically inoperable patients: Results from the American College of Surgeons Oncology Group Z4033 (Alliance) trial.

BACKGROUND: This study evaluated the 2-year overall survival rate, adverse event rate, local control rate, and impact on pulmonary function tests for medically inoperable patients with stage IA non-small cell lung cancer (NSCLC) undergoing computed tomography (CT)-guided radiofrequency ablation (RFA) in a prospective, multicenter trial. METHODS: Fifty-four patients (25 men and 29 women) with a median age of 76 years (range, 60-89 years) were enrolled from 16 US centers; 51 patients were eligible for evaluation (they had biopsy-proven stage IA NSCLC and were deemed medically inoperable by a board-certified thoracic surgeon). Pulmonary function tests were performed within the 60 days before RFA and 3 and 24 months after RFA. Adverse events were recorded and categorized. Patients were followed with CT and fludeoxyglucose positron emission tomography. Local control rate and recurrence patterns were analyzed. RESULTS: The overall survival rate was 86.3% at 1 year and 69.8% at 2 years. The local tumor recurrence-free rate was 68.9% at 1 year and 59.8% at 2 years and was worse for tumors > 2 cm. In the 19 patients with local recurrence, 11 were re-treated with RFA, 9 underwent radiation, and 3 underwent chemotherapy. There were 21 grade 3 adverse events, 2 grade 4 adverse events, and 1 grade 5 adverse event in 12 patients within the first 90 days after RFA. None of the grade 4 or 5 adverse events were attributable to RFA. There was no significant change in the forced expiratory volume in the first second of expiration or the diffusing capacity of lung for carbon monoxide after RFA. A tumor size less than 2.0 cm and a performance status of 0 or 1 were associated with statistically significant improved survival of 83% and 78%, respectively, at 2 years. CONCLUSIONS: RFA is a single, minimally invasive procedure that is well tolerated in medically inoperable patients, does not adversely affect pulmonary function tests, and provides a 2-year overall survival rate that is comparable to the rate reported after stereotactic body radiotherapy in similar patients.

Minimally invasive esophagectomy: results of a prospective phase II multicenter trial-the eastern cooperative oncology group (E2202) study.

OBJECTIVE: The primary aim of this trial was to assess the feasibility of minimally invasive esophagectomy (MIE) in a multi-institutional setting. BACKGROUND: Esophagectomy is an important, potentially curative treatment for localized esophageal cancer, but is a complex operation. MIE may decrease the morbidity and mortality of resection, and single-institution studies have demonstrated successful outcomes with MIE. METHODS: We conducted a multicenter, phase II, prospective, cooperative group study (coordinated by the Eastern Cooperative Oncology Group) to evaluate the feasibility of MIE. Patients with biopsy-proven high-grade dysplasia or esophageal cancer were enrolled at 17 credentialed sites. Protocol surgery consisted of either 3-stage MIE or Ivor Lewis MIE. The primary end point was 30-day mortality. Secondary end points included adverse events, duration of hospital-stay, and 3-year outcomes. RESULTS: Protocol surgery was completed in 95 of the 104 patients eligible for the primary analysis (91.3%). The 30-day mortality in eligible patients who underwent MIE was 2.1%; perioperative mortality in all registered patients eligible for primary analysis was 2.9%. Median intensive care unit and hospital stay were 2 and 9 days, respectively. Grade 3 or higher adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%). At a median follow-up of 35.8 months, the estimated 3-year overall survival was 58.4% (95% confidence interval: 47.7%-67.6%). Locoregional recurrence occurred in only 7 patients (6.7%). CONCLUSIONS: This prospective multicenter study demonstrated that MIE is feasible and safe with low perioperative morbidity and mortality and good oncological results. This approach can be adopted by other centers with appropriate expertise in open esophagectomy and minimally invasive surgery.

Application of drainage strategy with bi-pigtail catheters in patients undergoing lobectomy by uniportal video-assisted thoracic surgery.

Background: There are no standard guidelines regarding the number and size of chest tubes that should be selected after thoracic surgery. This study aimed to evaluate the effects of adopting a drainage strategy with bi-pigtail catheters (BPCs) on patients undergoing lobectomy by uniportal video-assisted thoracic surgery (VATS). Methods: A retrospective study was performed of patients undergoing uniportal lobectomy at the Department of Thoracic Surgery of the Cancer Hospital of Dalian University of Technology between August 2021 and August 2022. The patients were divided into the following two groups according to the drainage strategy adopted: (I) a traditional chest tube (TCT) group; and (II) a BPC group. The outcomes measured included postoperative complications, as measured by the Clavien-Dindo method, and the visual analogue scale (VAS) pain scores of the patients after surgery. Results: In total, 868 patients underwent lung resection during the study period, after exclusion, the data of 470 patients who underwent uniport lobectomy were reviewed (235 in the TCT group, and 235 in the BPC group). There were no statistically significant differences between the two groups in terms of baseline data (P>0.05). The incidence of postoperative complications (7.7% vs. 19.1%) and postoperative VAS pain scores at 7-24 hours (3.3±1.0 vs. 3.7±1.5) and 25-48 hours (3.1±0.8 vs. 3.6±1.5) were significantly lower in the BPC group than the TCT group (all P<0.001). Additionally, the postoperative length of stay (4.6±1.5 vs. 5.4±4.5 days) and the collapse rate of the residual lung (19.2%±9.1% vs. 20.9%±9.6%) of the BPC group were better than those of the TCT group (P<0.05). The results of univariable and multivariable analyses showed that a drainage strategy with a TCT was an independent risk factor for decreased postoperative complications, and reduced moderate or severe pain scores at 7-24 and 25-48 hours after surgery. Conclusions: Our drainage strategy with BPCs decreased the incidence of postoperative complications and alleviated the postoperative pain of patients undergoing lobectomy by uniportal VATS and is safe and feasible.

Comprehensive value implications of surgeon volume for lung cancer surgery: Use of an analytic framework within a regional health system.

Objective: We used a framework to assess the value implications of thoracic surgeon operative volume within an 8-hospital health system. Methods: Surgical cases for non-small cell lung cancer were assessed from March 2015 to March 2021. High-volume (HV) surgeons performed >25 pulmonary resections annually. Metrics include length of stay, infection rates, 30-day readmission, in-hospital mortality, median 30-day charges and direct costs, and 3-year recurrence-free and overall survival. Multivariate regression-based propensity scores matched patients between groups. Metrics were graphed on radar charts to conceptualize total value. Results: All 638 lung resections were performed by 12 surgeons across 6 hospitals. Two HV surgeons performed 51% (n = 324) of operations, and 10 low-volume surgeons performed 49% (n = 314). Median follow-up was 28.8 months (14.0-42.3 months). Lobectomy was performed in 71% (n = 450) of cases. HV surgeons performed more segmentectomies (33% [n = 107] vs 3% [n = 8]; P < .001). Patients of HV surgeons had a lower length of stay (3 [2-4] vs 5 [3-7]; P < .001) and infection rates (0.6% [n = 1] vs 4% [n = 7]; P = .03). Low-volume and HV surgeons had similar 30-day readmission rates (14% [n = 23] vs 7% [n = 12]; P = .12), in-hospital mortality (0% [n = 0] vs 0.6% [n = 1]; P = .33), and oncologic outcomes; 3-year recurrence-free survival was 95% versus 91%; P = .44, and 3-year overall survival was 94% versus 90%; P = 0. Charges were reduced by 28%, and direct costs were reduced by 23% (both P < .001) in the HV cohort. Conclusions: HV surgeons provide comprehensive value across a health system. This multidomain framework can be used to help drive oncologic care decisions within a health system.

Outcomes following minimally invasive approaches vs. open extended lobectomy for non-small cell lung cancer: a propensity-matched analysis of the National Cancer Database.

Background: Traditional thoracotomy, an invasive surgical procedure, has been the standard approach for extended lobectomy in treating non-small cell lung cancer (NSCLC). However, minimally invasive surgery (MIS) has gained traction with advancements in surgical techniques. Despite this, the outcomes of extended lobectomy via a minimally invasive approach remain largely uncharted. Using the comprehensive National Cancer Database (NCDB), our research aimed to clarify the safety, feasibility, and efficacy of minimally invasive extended lobectomy in patients diagnosed with NSCLC. Methods: Our study encompassed a selection of patients with NSCLC who underwent extended lobectomy (defined as lobectomy or bilobectomy with chest wall, diaphragm or pericardial resection) between 2010 and 2014. Through propensity score matching (PSM), we ensured a balanced comparison between patients who underwent MIS and those who opted for the traditional open extended lobectomy. Both univariate and multivariate analyses were employed to discern whether the surgical approach had any significant impact on the prognosis of patients undergoing this specific procedure. Results: Before PSM, our dataset included 3,934 patients. After 1:2 PSM, the MIS group included 683 cases, while the open group included 1,317 cases. One notable finding was the reduced average postoperative hospital stay for the MIS group at 7.15 days compared to the open group at 8.40 days (P<0.001). Furthermore, the 5-year survival rate was similar, with the MIS group at 53.1% and the open group at 51.3% (P=0.683). Conclusions: The results of our study suggest that MIS for extended lobectomy not only is safe and feasible but also is oncologically effective. However, it is imperative to note that these encouraging findings necessitate further validation through prospective studies to ascertain the full scope of benefits and potential risks associated with MIS.

The Society of Thoracic Surgeons Expert Consensus Document on the Management of Pleural Drains After Pulmonary Lobectomy: Expert Consensus Document.

The Society of Thoracic Surgeons Workforce on Evidence-Based Surgery provides this document on management of pleural drains after pulmonary lobectomy. The goal of this consensus document is to provide guidance regarding pleural drains in 5 specific areas: (1) choice of drain, including size, type, and number; (2) management, including use of suction vs water seal and criteria for removal; (3) imaging recommendations, including the use of daily and postpull chest roentgenograms; (4) use of digital drainage systems; and (5) management of prolonged air leak. To formulate the consensus statements, a task force of 15 general thoracic surgeons was invited to review the existing literature on this topic. Consensus was obtained using a modified Delphi method consisting of 2 rounds of voting until 75% agreement on the statements was reached. A total of 13 consensus statements are provided to encourage standardization and stimulate additional research in this important area.

Stereotactic Body Radiation Therapy Versus Ablation Versus Surgery for Early-Stage Lung Cancer in High-Risk Patients.

Current treatment for early-stage lung cancer focuses on surgical intervention as the mainstay of treatment; however, this poses issues in patients that are high-risk or unable to tolerate any operation. In this case, sublobar resection or radiation therapy has been the primary treatment for these subsets of patients. Alternative approaches include stereotactic body radiation therapy (SBRT) and thermal ablation. In this article, we focus on treatment strategies using SBRT, thermal ablation, or surgery as it pertains to high-risk patients with early-stage lung cancer.

Intercostal Cryoablation During Video-Assisted Lung Resection Can Decrease Postoperative Opioid Use.

OBJECTIVE: Pain requiring opioid use remains an issue even with minimally invasive thoracic surgery. The objective of this study was to investigate the effectiveness of intercostal nerve cryoablation (CRYO) for pain control in adult patients undergoing pulmonary resection. METHODS: A retrospective analysis of patients undergoing pulmonary resection by uniportal video-assisted thoracic (uVATS) approach was undertaken. Patients treated with our usual pain regimen (STANDARD) were compared with those who additionally received CRYO. STANDARD includes intercostal bupivacaine, patient-controlled analgesia (24 h), ketorolac (48 to 72 h), and tramadol. Intraoperative CRYO was performed on 5 intercostal levels. The primary aim was to compare pain scores (range, 0 to 10) and morphine equivalent dosages (MED). Secondary outcomes included length of stay, chest tube duration, presence of an air leak, and adverse events. A p value <0.05 was considered significant. RESULTS: There were 49 patients (34 female, 15 male). The median age was 74 (37 to 90) years. Procedures included lobectomy (n = 32), segmentectomy (n = 7), and wedge resections (n = 10). There were 23 (46.9%) CRYO and 26 (53.1%) STANDARD patients. Baseline characteristics were similar. Mean length of stay (2.9 vs 3.5 days), chest tube duration (2.2 vs 1.8 days), and adverse events (9 of 23 vs 7 of 26) were similar. There were no complications attributable to CRYO. Pain scores were not significantly different on postoperative days (POD) 1 to 4. MED was significantly reduced after CRYO on POD 1 (5 vs 47.24), POD 2 (10.93 vs 25.04), POD 3 (8.13 vs 21.7), and POD 4 (7.08 vs 19.17). CONCLUSIONS: CRYO can be performed safely during pulmonary resection and can decrease in-hospital opioid use. The results from this retrospective study will need to be validated in future prospective studies.

Challenges of Implementing Lung Cancer Screening in a Developing Country: Results of the Second Brazilian Early Lung Cancer Screening Trial (BRELT2).

PURPOSE: This paper aims to present the results of a series of several Brazilian institutions that have been carrying out lung cancer screening (LCS). MATERIALS AND METHODS: This is a retrospective, cohort study, with follow-up of individuals of both sexes, with a heavy smoking history, who participated in LCS programs between December 2013 and January 2021 in six Brazilian institutions located in the states of São Paulo, Rio Grande do Sul, and Bahia. RESULTS: Three thousand four hundred seventy individuals were included, of which 59.8% were male (n = 2,074) and 50.6% were current smokers (n = 1,758), with 60.7 years (standard deviation 8.8 years). Lung-RADS 4 was observed in 233 (6.7%) patients. Biopsy was indicated by minimally invasive methods in 122 patients (3.5%). Two patients who demonstrated false-negative biopsies and lung cancer were diagnosed in follow-up. Diagnosis of lung cancer was observed in 74 patients (prevalence rate of 2.1%), with 52 (70.3%) in stage I or II. Granulomatous disease was found in 20 patients. There were no statistical differences in the incidence of lung cancer, biopsies, granulomatous disease, and Lung-RADS 4 nodules between public and private patients. CONCLUSION: There are still many challenges and obstacles in the implementation of LCS in developing countries; however, our multi-institutional data were possible to obtain satisfactory results in these scenarios and to achieve similar results to the main international studies. Granulomatous diseases did not increase the number of lung biopsies. The authors hope that it could stimulate the creation of organized screening programs in regions still endemic for tuberculosis and other granulomatous diseases.

Radiofrequency ablation of medically inoperable stage IA non-small cell lung cancer: are early posttreatment PET findings predictive of treatment outcome?

OBJECTIVE: The purpose of this study was to evaluate initial experience with (18)F-FDG PET/CT after pulmonary radiofrequency ablation of stage IA non-small cell lung cancer to determine whether treatment success or residual disease can be predicted with early postablation PET. SUBJECTS AND METHODS: Thirty patients with medically inoperable stage IA non-small cell lung cancer (12 men, 18 women; median age, 76 years; range, 60-87 years) underwent outpatient CT-guided radiofrequency ablation over a 33-month period. Mean tumor size was 2.0 cm (range, 1.3-2.9 cm). PET/CT was performed within 60 days before radiofrequency ablation (RFA), within 4 days after RFA, and 6 months after RFA. Metabolic response was categorized as complete response or partial or no response at early post-RFA PET/CT and complete response, partial response, or progressive metabolic disease at 6-month post-RFA PET/CT and was compared with the 1-year clinical event rate (death, disease progression at contrast-enhanced CT, or repeat ablation). RESULTS: Early PET/CT images, obtained within 4 days of RFA, were evaluable for 26 patients (23 at 6 months). Patients with a complete metabolic response at early PET/CT had a 1-year event rate of 43%, whereas those with partial or no response or disease progression had a 1-year event rate of 67% (p = 0.27). Patients with a complete metabolic response at 6-month PET/CT had a 1-year event rate of 0%. Those with a partial response and those with disease progression had an overall event rate of 75% (p = 0.001). CONCLUSION: Early post-RFA PET/CT is not necessary and 6-month post-RFA PET/CT findings correlate better with clinical outcome at 1 year.

Multifactorial dysphagia: Azygos vein aneurysm (AVA) and esophagogastric junction outflow obstruction (EGJOO).

INTRODUCTION: Vascular impingement of the esophagus is a rare cause of dysphagia, and is most commonly due to aortic arch anomalies such as arterial lusoria. Dysphagia resultant from venous compression is even further less likely. PRESENTATION OF CASE: We present a highly unusual case of dysphagia secondary to a large aneurysm of the azygous vein near its confluence with the superior vena cava, which was managed with endovascular modalities. Despite initial treatment success, patient reported some intermittent solid food dysphagia, and was also found to have esophagogastric junction outflow obstruction (EGJOO) on high resolution impedance manometry (HRIM) which was successfully managed with surgical myotomy and partial fundoplication. DISCUSSION: The azygos vein has an intimate anatomic relationship with the esophagus as it traverses the posterior mediastinum. Because of this anatomic association, the azygos vein may present a point of esophageal obstruction in the setting of significant pathology. CONCLUSION: This case highlights the possibility of multifactorial causes of dysphagia, and that HRIM is a key aspect of this workup. Additionally we discuss the pertinent anatomy, diagnosis, and treatments for azygos vein aneurysm and EGJOO.

Derivation and validation of a nomogram model for pulmonary thromboembolism in patients undergoing lung cancer surgery.

BACKGROUND: A specific risk-stratification tool is needed to facilitate safe and cost-effective approaches to the prophylaxis of acute pulmonary thromboembolism (PTE) in lung cancer surgery patients. This study aimed to develop and validate a simple nomogram model for the prediction of PTE after lung cancer surgery using readily obtainable clinical characteristics. METHODS: A total of 14,427 consecutive adult patients who underwent lung cancer surgery between January 2015 and July 2018 in our institution were retrospectively reviewed. Included in the cohort were 136 patients who developed PTE and 544 non-PTE patients. The patients were randomly divided into the derivation group (70%, 95 PTE patients and 380 non-PTE patients) and the validation group (30%, 41 PTE patients and 164 non-PTE patients). A nomogram model was developed based on the results of multivariate logistic analysis in the derivation group. The cut-off values were defined using Youden's index. The prognostic accuracy was measured by area under the curve (AUC) values. RESULTS: In the derivation group, multivariate logistic analysis was carried out to evaluate the risk score. The risk assessment model contained five variables: age [95% confidence interval (CI): 1.008-1.083, P=0.016], body mass index (95% CI: 1.077-1.319, P=0.001), operation time (95% CI: 1.002-1.014, P=0.008), the serum level of cancer antigen 15-3 (CA15-3) before surgery (95% CI: 1.019-1.111, P=0.005), and the abnormal results of compression venous ultrasonography before surgery (95% CI: 2.819-18.838, P<0.001). All of them were independent risk factors of PTE. To simplify the risk assessment model, a nomogram model was established, which showed a good predictive performance in the derivation group (AUC 0.792, 95% CI: 0.734-0.853) and in the validation group (AUC 0.813, 95% CI: 0.737-0.890). CONCLUSIONS: A high-performance nomogram was established on the risk factors for PTE in patients undergoing lung cancer surgery. The nomogram could be used to provide an individual risk assessment and guide prophylaxis decisions for patients. Further external validation of the model is needed in lung cancer surgery patients in other clinical centers.

Pathological complete response after neoadjuvant treatment determines survival in esophageal squamous cell carcinoma patients (NEOCRTEC5010).

BACKGROUND: Few studies have exclusively investigated the value of pathological complete response (pCR), in esophageal squamous cell carcinoma (ESCC) patients, although it is a clinically significant parameter to evaluate the impact of neoadjuvant chemoradiotherapy (nCRT) on treatment outcome after surgery. The aim of our study was to explore the relationship between pCR after nCRT and survival among patients with local ESCC. METHODS: All patients receiving nCRT followed by surgery in NEOCRTEC5010-trial (NCT01216527) were included. Non-pCR patients were classified into three subgroups: ypTanyN0M0, ypT0NanyM0 and ypTanyNanyM0. The Kaplan-Meier method with log-rank test was employed to evaluate disease-free survival (DFS) and overall survival (OS). Multivariate regression analysis was performed using a Cox proportional hazards model to identify clinicopathological parameters associated with pCR. RESULTS: Among the 185 patients included, 80 (43.2%) achieved pCR after nCRT. The mean survival time of the pCR group was significantly longer than that of the non-pCR group (92.6 vs. 69.2 months; HR, 2.70; 95% CI: 1.48-4.92; P=0.001). The 5-year OS and DFS of the pCR group were 79.3% and 77% respectively, compared to 54.8% and 51.2%, respectively, in the non-pCR group. The results showed that the OS and DFS of the ypTanyN0M0 group were better than those of the ypT0NanyM0 group and the ypTanyNanyM0 group. We also found that the number of dissected lymph nodes and pCR were independent risk factors for DFS and OS rates. CONCLUSIONS: pCR after nCRT is an important prognostic indicator of OS and DFS in patients with ESCC. In addition, lymph-node status could represent an important parameter in the prognostic evaluation of esophageal cancer patients.

Peripheral Blood Lymphocytes and Platelets Are Prognostic in Surgical pT1 Non-Small Cell Lung Cancer.

BACKGROUND: There is a paucity of prognostic factors for patients with stage I non-small cell lung cancer (NSCLC) undergoing operations. We investigated the prognostic role of preoperative complete blood count values in patients with stage I NSCLC patients undergoing operations. METHODS: A retrospective medical record review was performed of patients who underwent operations for stage I NSCLC between 2000 and 2015. Patients who died within 30 days of the operations were excluded. The primary end point was recurrence. Preoperative complete blood count values were analyzed, and a median value was used as the cutoff. Statistical analysis used χ2 and t tests along with univariate and multivariate analyses by Cox regression modeling. RESULTS: The study included 103 patients. A high lymphocyte count was significantly associated with recurrence (5-year recurrence-free survival [RFS] of 69.8% for high vs 95.7% for low, P = .003), as well as high platelet (5-year RFS of 72.0% for high vs 91.8% for low, P = .02). Independent prognostic factors on multivariate analysis were high lymphocyte (hazard ratio [HR], 7.27; P = .005) and platelet counts (HR, 7.49; P = .003) as well as tumor (HR, 5.40; P = .008) and treatment characteristics (HR, 4.59; P = .01). Among patients with pT1 lesions, high lymphocyte (HR, 8.41; P = .03) and high platelet counts (HR, 19.78; P = .004) remained independent prognostic factors. Neither NLR nor PLR were significantly associated with recurrence. CONCLUSIONS: In patients with pathologic stage I NSCLC undergoing surgical resection, the preoperative blood count from peripheral blood may provide prognostic value. Of significance, in patients with pT1 N0 NSCLC, high lymphocyte count and high platelet count were associated with higher recurrence.

Fibrin sealant for esophageal anastomosis: A phase II study.

BACKGROUND: Esophagectomy is a pivotal curative modality for localized esophageal or esophagogastric junction cancer (EC or EJC). Postoperative anastomotic leakage (AL) remains problematic. The use of fibrin sealant (FS) may improve the strength of esophageal anastomosis and reduce the incidence of AL. AIM: To assess the efficacy and safety of applying FS to prevent AL in patients with EC or EJC. METHODS: In this single-arm, phase II trial (Clinicaltrial.gov identifier: NCT03529266), we recruited patients aged 18-80 years with resectable EC or EJC clinically staged as T1-4aN0-3M0. An open or minimally invasive McKeown esophagectomy was performed with a circular stapled anastomosis. After performing the anastomosis, 2.5 mL of porcine FS was applied circumferentially. The primary endpoint was the proportion of patients with AL within 3 mo. RESULTS: From June 4, 2018, to December 29, 2018, 57 patients were enrolled. At the data cutoff date (June 30, 2019), three (5.3%) of the 57 patients had developed AL, including two (3.5%) with esophagogastric AL and one (1.8%) with gastric fistula. The incidence of anastomotic stricture and other major postoperative complications was 1.8% and 17.5%, respectively. The median time needed to resume oral feeding after operation was 8 d (Interquartile range: 7.0-9.0 d). No adverse events related to FS were recorded. No deaths occurred within 90 d after surgery. CONCLUSION: Perioperative sealing with porcine FS appears safe and may prevent AL after esophagectomy in patients with resectable EC or EJC. Further phase III studies are warranted.

Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE).

OBJECTIVE: To assess the safety and local recurrence-free survival in patients after cryoablation for treatment of pulmonary metastases. METHODS: This multicenter, prospective, single-arm, phase 2 study included 128 patients with 224 lung metastases treated with percutaneous cryoablation, with 12 and 24 months of follow-up. The patients were enrolled on the basis of the outlined key inclusion criteria, which include one to six metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm. Time to progression of the index tumor(s), metastatic disease, and overall survival rates were estimated using the Kaplan-Meier method. Complications were captured for 30 days after the procedure, and changes in performance status and quality of life were also evaluated. RESULTS: Median size of metastases was 1.0 plus or minus 0.6 cm (0.2-4.5) with a median number of tumors of 1.0 plus or minus 1.2 cm (one to six). Local recurrence-free response (local tumor efficacy) of the treated tumor was 172 of 202 (85.1%) at 12 months and 139 of 180 (77.2%) at 24 months after the initial treatment. After a second cryoablation treatment for recurrent tumor, secondary local recurrence-free response (local tumor efficacy) was 184 of 202 (91.1%) at 12 months and 152 of 180 (84.4%) at 24 months. Kaplan-Meier estimates of 12- and 24-month overall survival rates were 97.6% (95% confidence interval: 92.6-99.2) and 86.6% (95% confidence interval: 78.7-91.7), respectively. Rate of pneumothorax that required pleural catheter placement was 26% (44/169). There were eight grade 3 complication events in 169 procedures (4.7%) and one (0.6%) grade 4 event. CONCLUSION: Percutaneous cryoablation is a safe and effective treatment for pulmonary metastases.