Preoperative mediastinal staging in early-stage lung cancer: Targeted nodal sampling is not inferior to systematic nodal sampling.

OBJECTIVE: To determine whether targeted sampling (TS), which omits biopsy of triple- normal lymph nodes (LNs) on positron emission tomography, computed tomography, and endobronchial ultrasound (EBUS), is noninferior to systematic sampling (SS) of mediastinal LNs during EBUS for staging of patients with early-stage non-small cell lung cancer (NSCLC). METHODS: Patients who are clinical nodal (cN)0-N1 with suspected NSCLC eligible for EBUS based on positron emission tomography/computed tomography were enrolled in this prospective, multicenter trial. During EBUS, all patients underwent TS and then crossed over to SS, whereby at least 3 mediastinal LN stations (4R, 4L, 7) were routinely sampled. Gold standard of comparison was pathologic results. Based on the previous feasibility trial, a noninferiority margin of 6% was established for difference in missed nodal metastasis (MNM) incidence between TS and SS. The McNemar test on paired proportions was used to determine MNM incidence for each sampling method. Analysis was per-protocol using a level of significance of P < .05. RESULTS: Between November 2020 and April 2022, 91 patients were enrolled at 6 high-volume Canadian tertiary care centers. A total of 256 LNs underwent TS and SS. Incidence of MNM was 0.78% in SS and 2.34% in TS, with an absolute difference of 1.56% (95% confidence interval, -0.003% to 4.1%; P = .13). This falls within the noninferiority margin. A total of 6/256 LNs from 4 patients who were not sampled by TS were found to be malignant when sampled by SS. CONCLUSIONS: In high-volume thoracic endosonography centers, TS is not inferior to SS in nodal staging of early-stage NSCLC. This results in change of clinical management for a minority of patients.

Preconditioning program reduces the incidence of prolonged hospital stay after lung cancer surgery: Results from the Move For Surgery randomized clinical trial.

BACKGROUND: Lung cancer resection is associated with high rates of prolonged hospital stay. It is presumed that preconditioning with aerobic exercise can shorten the postoperative duration of hospital stay, but this has not yet been demonstrated in trials after lung cancer surgery. The aim of this study was to perform a RCT to determine whether Move For Surgery (MFS), a home-based and wearable technology-enhanced preconditioning program before lung cancer surgery, is associated with a lower incidence of prolonged hospital stay when compared to usual preoperative care. METHODS: Patients undergoing lung resection for early-stage non-small cell lung cancer were enrolled before surgery into this blinded, single-site RCT, and randomized to either the MFS or control group in a 1 : 1 ratio. Patients in the MFS group were given a wearable activity tracker, and education about deep breathing exercises, nutrition, sleep hygiene, and smoking cessation. Participants were motivated/encouraged to reach incrementally increasing fitness goals remotely. Patients in the control group received usual preoperative care. The primary outcome was the difference in proportion of patients with hospital stay lasting more than 5 days between the MFS and control groups. RESULTS: Of 117 patients screened, 102 (87.2 per cent) were eligible, enrolled, and randomized (51 per trial arm). The majority (95 of 102, 93.1 per cent) completed the trial. Mean(s.d.) age was 67.2(8.8) years and there were 55 women (58 per cent). Type of surgery and rates of thoracotomy were not different between arms. The proportion of patients with duration of hospital stay over 5 days was 3 of 45 (7 per cent) in the MFS arm compared to 12 of 50 (24 per cent) in the control arm (P = 0.021). CONCLUSION: MFS, a home-based and wearable technology-enhanced preconditioning program before lung cancer surgery, decreased the proportion of patients with a prolonged hospital stay. Registration number: NCT03689634 (http://www.clinicaltrials.gov).

After lung cancer surgery, many patients are admitted to hospital for a prolonged amount of time. It is believed that exercises undertaken before surgery can shorten the stay in hospital, but this has not yet been studied. This study aimed to find out whether Move For Surgery (MFS), a home-based exercise (preconditioning) program using wearable technology before lung cancer surgery, can decrease the number of patients who are admitted to hospital for a prolonged amount of time. Patients with lung cancer were invited to enter this trial 3­4 weeks before surgery. They were randomly put into the MFS or control group. Patients in the MFS group were given a wearable activity tracker, and education about deep breathing exercises, nutrition, sleep hygiene, and quitting smoking. Participants were encouraged to reach increasing fitness goals each week. Patients in the control group underwent usual preoperative care. The difference between the MFS and control groups in the proportion of patients with duration of stay in hospital exceeding 5 days was studied. There were 102 participants in total, 51 in each group. The majority (95 of 102, 93.1 per cent) completed the trial. The average age of participants was 67 years, and 58 per cent were women. Type of surgery and number of open operations were no different between groups. The proportion of patients with duration of stay greater than 5 days was 3 of 45 (7 per cent) in the MFS group compared with 12 of 50 (24 per cent) in the control group. Therefore, MFS before lung cancer surgery was shown to decrease the number of patients admitted to hospital for a prolonged amount of time.

Robotic thoracic surgery in Canada: Are patients willing to pay out of pocket?

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective, but is associated with high capital and operating costs that are not reimbursed by the Canadian government. Currently, patients have access to RTS only when it is supported by research or philanthropic funds. In a recent study, we assessed the extent of patient-reported satisfaction with RTS, whether patients would have been willing to pay out of pocket for it, and what factors were associated with patients' willingness to pay. Many patients (290 of 411 [70.56%]) stated that they would have paid the additional $2000 to supplement the government health care coverage to have access to RTS. Factors found to be significantly associated with participants' willingness to pay were an annual income of $60 000 or more (p = 0.034), private insurance coverage (p = 0.007), overall experience with RTS rated as 8 or higher out of 10 (p < 0.001), and overall postoperative postdischarge experience rated as satisfying or very satisfying (p = 0.004).

Routine systematic sampling versus targeted sampling during endobronchial ultrasound: A randomized feasibility trial.

OBJECTIVE: Triple normal lymph nodes, appearing benign on computed tomography, positron emission tomography, and endobronchial ultrasound, have less than a 6% probability of malignancy. We hypothesized that targeted sampling (TS), which omits biopsy of triple normal lymph nodes during endobronchial ultrasound, is not an inferior staging strategy to systematic sampling (SS) of all lymph nodes. METHODS: A prospective randomized feasibility trial was conducted to decide on the progression to a pan-Canadian trial comparing TS with SS. Patients with cN0-N1 non-small cell lung cancer undergoing endobronchial ultrasound were randomized to TS or SS. Lymph nodes in the TS arm crossed over to receive SS. Progression criteria included recruitment rate (70% minimum), procedure length (no significant increase for TS), and incidence of missed nodal metastasis (<6%). Mann-Whitney U test and McNemar's test on paired proportions were used for statistical comparisons. RESULTS: The progression criterion of 70% recruitment rate was achieved early, triggering a planned early stoppage of the trial. Nineteen patients were allocated to each arm. The median procedure length for TS was significantly shorter than SS (3.07 vs 19.07 minutes; P < .001). After crossover analysis, 5.45% (95% confidence interval, 1.87-14.85) of lymph nodes in the TS arm were upstaged from N0 to N2, but this incidence of missed nodal metastasis was below the 6% threshold. During surgical resection, the nodal upstaging incidence from N0 to N2 was 0% for 15 lymph nodes in each arm. CONCLUSIONS: Progression criteria to a pan-Canadian, noninferiority crossover trial comparing TS with SS have been met, and such a trial is warranted.

An Artificial Intelligence Algorithm to Predict Nodal Metastasis in Lung Cancer.

BACKGROUND: Endobronchial ultrasound (EBUS) has features that allow a high accuracy for predicting lymph node (LN) malignancy. However their clinical application remains limited because of high operator dependency. We hypothesized that an artificial intelligence algorithm (NeuralSeg; NeuralSeg Ltd, Hamilton, Ontario, Canada) is capable of accurately identifying and predicting LN malignancy based on EBUS images. METHODS: In the derivation phase EBUS images were segmented twice by an endosonographer and used as controls in 5-fold cross-validation training of NeuralSeg. In the validation phase the algorithm was tested on new images it had not seen before. Logistic regression and receiver operator characteristic curves were used to determine NeuralSeg's capability of discrimination between benign and malignant LNs, using pathologic specimens as the gold standard. RESULTS: Two hundred ninety-eight LNs from 140 patients were used for derivation and 108 LNs from 47 patients for validation. In the derivation cohort NeuralSeg was able to predict malignant LNs with an accuracy of 73.8% (95% confidence interval [CI], 68.4%-78.7%). In the validation cohort NeuralSeg had an accuracy of 72.9% (95% CI, 63.5%-81.0%), specificity of 90.8% (95% CI, 81.9%-96.2%), and negative predictive value of 75.9% (95% CI, 71.5%-79.9%). NeuralSeg showed higher diagnostic discrimination during validation compared with derivation (c-statistic = 0.75 [95% CI, 0.65-0.85] vs 0.63 [95% CI, 0.54-0.72], respectively). CONCLUSIONS: NeuralSeg is able to accurately rule out nodal metastasis and can possibly be used as an adjunct to EBUS when nodal biopsy is not possible or inconclusive. Future work to evaluate the algorithm in a clinical trial is required.

Use of Incentive Spirometry in Adults following Cardiac, Thoracic, and Upper Abdominal Surgery to Prevent Post-Operative Pulmonary Complications: A Systematic Review and Meta-Analysis.

BACKGROUND: Currently, consensus on the effectiveness of incentive spirometry (IS) following cardiac, thoracic, and upper abdominal surgery has been based on randomized controlled trials (RCTs) and systematic reviews of lower methodological quality. To improve the quality of the research and to account for the effects of IS following thoracic surgery, in addition to cardiac and upper abdominal surgery, we performed a meta-analysis with thorough application of the Grading of Recommendations Assessment, Development and Evaluation scoring system and extensive reference to the Cochrane Handbook for Systematic Reviews of Interventions. OBJECTIVE: The objective of this study was to determine, with rigorous methodology, whether IS for adult patients (18 years of age or older) undergoing cardiac, thoracic, or upper abdominal surgery significantly reduces30-day post-operative pulmonary complications (PPCs), 30-day mortality, and length of hospital stay (LHS) when compared to other rehabilitation strategies. METHODS: The literature was searched using Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and Web of Science for RCTs between the databases' inception and March 2019. A random-effect model was selected to calculate risk ratios (RRs) with 95% confidence intervals (CIs). RESULTS: Thirty-one RCTs involving 3,776 adults undergoing cardiac, thoracic, or upper abdominal surgery were included. By comparing the use of IS to other chest rehabilitation strategies, we found that IS alone did not significantly reduce 30-day PPCs (RR = 1.00, 95% CI: 0.88-1.13) or 30-day mortality (RR = 0.73, 95% CI: 0.42-1.25). Likewise, there was no difference in LHS (mean difference = -0.17,95% CI: -0.65 to 0.30) between IS and the other rehabilitation strategies. None of the included trials significantly impacted the sensitivity analysis and publication bias was not detected. CONCLUSIONS: This meta-analysis showed that IS alone likely results in little to no reduction in the number of adult patients with PPCs, in mortality, or in the LHS, following cardiac, thoracic, and upper abdominal surgery.