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The increased detection of small-sized peripheral non-small-cell lung cancer (NSCLC) has renewed interest in sublobar resection in lieu of lobectomy. We conducted a multicenter, noninferiority, phase 3 trial in which patients with NSCLC clinically staged as T1aN0 (tumor size, ≤2 cm) were randomly assigned to undergo sublobar resection or lobar resection after intraoperative confirmation of node-negative disease. The primary end point was disease-free survival, defined as the time between randomization and disease recurrence or death from any cause. Secondary end points were overall survival, locoregional and systemic recurrence, and pulmonary functions. From June 2007 through March 2017, a total of 697 patients were assigned to undergo sublobar resection (340 patients) or lobar resection (357 patients). After a median follow-up of 7 years, sublobar resection was noninferior to lobar resection for disease-free survival (hazard ratio for disease recurrence or death, 1.01; 90% confidence interval [CI], 0.83 to 1.24). In addition, overall survival after sublobar resection was similar to that after lobar resection (hazard ratio for death, 0.95; 95% CI, 0.72 to 1.26). The 5-year disease-free survival was 63.6% (95% CI, 57.9 to 68.8) after sublobar resection and 64.1% (95% CI, 58.5 to 69.0) after lobar resection. The 5-year overall survival was 80.3% (95% CI, 75.5 to 84.3) after sublobar resection and 78.9% (95% CI, 74.1 to 82.9) after lobar resection. No substantial difference was seen between the two groups in the incidence of locoregional or distant recurrence. At 6 months postoperatively, a between-group difference of 2 percentage points was measured in the median percentage of predicted forced expiratory volume in 1 second, favoring the sublobar-resection group. In patients with peripheral NSCLC with a tumor size of 2 cm or less and pathologically confirmed node-negative disease in the hilar and mediastinal lymph nodes, sublobar resection was not inferior to lobectomy with respect to disease-free survival. Overall survival was similar with the two procedures. (Funded by the National Cancer Institute and others; CALGB 140503 ClinicalTrials.gov number, NCT00499330.).

Background: Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors. Objectives: The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema. Methods: Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone). Results: The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, p = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group. Conclusion: The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile.

Background The standard surgical treatment for early-stage non-small cell lung cancer (NSCLC) involves anatomical lobectomy and mediastinal lymph node dissection (MLND). According to the principle of “from distal to proximal” during tumour resection, MLND should ideally be performed before lobectomy to fit the criteria of surgical oncology. However, no prospective randomised controlled trial (RCT) has compared MLND-first versus lobectomy-first approaches in early-stage NSCLC. This provides the rationale for this multicentre RCT. Methods This multicentre, prospective, open-label, RCT investigates the superiority of MLND-first over lobectomy-first in terms of long-term survival in patients with clinical stage T1-2N0-1M0 (stages I–II) NSCLC (LOFTY study). We plan to enrol 620 patients from multiple institutions. Stratified block randomisation will be performed in this trial. The primary endpoint is the 5-year disease-free survival rate, and the secondary endpoints comprise the 5-year overall survival rate and short-term outcomes, such as conversion rate, perioperative complication rate, number of resected mediastinal lymph nodes, operative death rate, postoperative hospital stays, R0 rate, operative time, chest tube duration, number of circulating tumour cells before and after operation, and the total cost of hospitalisation. The primary endpoint will be assessed by a central committee of blinded expert radiologists. Patient recruitment is currently ongoing. Discussion This multicentre, prospective, open-label RCT investigates whether MLND-first is superior to lobectomy-first in terms of long-term outcomes in early-stage NSCLC patients who are suitable for lobectomies. The results of this trial will provide high-level evidence to clarify the standard surgical sequence for early-stage operable NSCLC. Trial registration Guangdong Association Study of Thoracic Oncology GASTO-10129. Registered on 26 March. 2022. Chinese Clinical Trials Registry ChiCTR2300068586. Registered on 24 February 2023. ClinicalTrial.gov NCT06577792. Registered on 29 August 2024.

Postoperative hemithoracic radiotherapy has been used to treat malignant pleural mesothelioma, but it has not been assessed in a randomised trial. We assessed high-dose hemithoracic radiotherapy after neoadjuvant chemotherapy and extrapleural pneumonectomy in patients with malignant pleural mesothelioma. We did this phase 2 trial in two parts at 14 hospitals in Switzerland, Belgium, and Germany. We enrolled patients with pathologically confirmed malignant pleural mesothelioma; resectable TNM stages T1–3 N0–2, M0; WHO performance status 0–1; age 18–70 years. In part 1, patients were given three cycles of neoadjuvant chemotherapy (cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on day 1 given every 3 weeks) and extrapleural pneumonectomy; the primary endpoint was complete macroscopic resection (R0–1). In part 2, participants with complete macroscopic resection were randomly assigned (1:1) to receive high-dose radiotherapy or not. The target volume for radiotherapy encompassed the entire hemithorax, the thoracotomy channel, and mediastinal nodal stations if affected by the disease or violated surgically. A boost was given to areas at high risk for locoregional relapse. The allocation was stratified by centre, histology (sarcomatoid vs epithelioid or mixed), mediastinal lymph node involvement (N0–1 vs N2), and T stage (T1–2 vs T3). The primary endpoint of part 1 was the proportion of patients achieving complete macroscopic resection (R0 and R1). The primary endpoint in part 2 was locoregional relapse-free survival, analysed by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00334594. We enrolled patients between Dec 7, 2005, and Oct 17, 2012. Overall, we analysed 151 patients receiving neoadjuvant chemotherapy, of whom 113 (75%) had extrapleural pneumonectomy. Median follow-up was 54·2 months (IQR 32–66). 52 (34%) of 151 patients achieved an objective response. The most common grade 3 or 4 toxic effects were neutropenia (21 [14%] of 151 patients), anaemia (11 [7%]), and nausea or vomiting (eight [5%]). 113 patients had extrapleural pneumonectomy, with complete macroscopic resection achieved in 96 (64%) of 151 patients. We enrolled 54 patients in part 2; 27 in each group. The main reasons for exclusion were patient refusal (n=20) and ineligibility (n=10). 25 of 27 patients completed radiotherapy. Median total radiotherapy dose was 55·9 Gy (IQR 46·8–56·0). Median locoregional relapse-free survival from surgery, was 7·6 months (95% CI 4·5–10·7) in the no radiotherapy group and 9·4 months (6·5–11·9) in the radiotherapy group. The most common grade 3 or higher toxic effects related to radiotherapy were nausea or vomiting (three [11%] of 27 patients), oesophagitis (two [7%]), and pneumonitis (two [7%]). One patient died of pneumonitis. We recorded no toxic effects data for the control group. Our findings do not support the routine use of hemithoracic radiotherapy for malignant pleural mesothelioma after neoadjuvant chemotherapy and extrapleural pneumonectomy. Swiss Group for Clinical Cancer Research, Swiss State Secretariat for Education, Research and Innovation, Eli Lilly.

Abstract Background: Bronchoscopic lung volume reduction using endobronchial coils is a new treatment for patients with severe emphysema. To date, the benefits have been modest and have been suggested to be much larger in patients with severe hyperinflation and nonmulti-comorbidity. Objective: We aimed to evaluate the efficacy and safety of endobronchial coil treatment in a randomized multicenter clinical trial using optimized patient selection. Method: Patients with severe emphysema on HRCT scan with severe hyperinflation (residual volume [RV] ≥200% predicted and RV/total lung capacity [TLC] >55%) were randomized to coil treatment or control. Primary outcome measures were differences in the forced expiratory volume in 1 s (FEV1) and St George’s Respiratory Questionnaire (SGRQ) total score at 6 months. Results: Due to premature study termination, a total of 120 patients (age 63 ± 7 years, FEV1 29 ± 7% predicted, RV 251 ± 41% predicted, RV/TLC 67 ± 6%, and SGRQ 58 ± 13 points), instead of 210 patients, were randomized. At study termination, 91 patients (57 coil and 34 control) had 6-month results available. Analyses showed significantly greater improvements in favor of the coil group. The increase in FEV1 was greater in the coil group than that in the control group by + 10.3 [+4.7 to +16.0] % and in SGRQ by −10.6 [−15.9 to −5.4] points. At study termination, there were 5 (6.8%) deaths in the coil cohort reported. Conclusion: Despite early study termination, coil treatment compared to control results in a significant improvement in the lung function and quality of life benefits for up to 6 months in patients with emphysema and severe hyperinflation. These improvements were of clinical importance but were associated with a higher likelihood of serious adverse events.

Ciprofol, a new candidate drug, is effective and safe for the maintenance of anesthesia in non-cardiothoracic and non-neurological elective surgery. However, few studies have been conducted on general anesthesia using ciprofol in patients undergoing thoracoscopic lobectomy. Therefore, this study aims to observe the effects of ciprofol on hemodynamics and on postoperative recovery in patients undergoing thoracoscopic lobectomy. This randomized controlled trial will include 136 patients aged 18-65 years undergoing elective thoracoscopic lobectomy between April 2023 and December 2024. The participants will be randomly assigned to the propofol or ciprofol group. The primary outcome to be assessed is the hemodynamic fluctuation during the induction and maintenance of anesthesia. The secondary outcomes involve quality of anesthesia induction and quality of recovery from anesthesia. The former includes TLOC (time to loss of consciousness), the use of vasoactive agents, the incidence of injection pain, body movement, muscle twitching and coughing during induction of anesthesia. The latter includes TROC (time to recovery of consciousness), post anesthesia care unit (PACU) time, incidence of postoperative nausea and vomiting (PONV), postoperative agitation, intraoperative awareness and quality of recovery (QoR) score. A number of clinical trials have confirmed that ciprofol, as a new sedative-hypnotic agent, has advantages of better tolerance, higher sedation satisfaction score, and lower incidence of adverse reactions, especially in reducing the incidence of injection pain. But considering that ciprofol was recently developed, limited data are available regarding its use for general anesthesia. This study aims to investigate the effects of ciprofol on hemodynamics and on postoperative recovery of patients undergoing thoracoscopic lobectomy. The results of this study may provide evidence for the safe application of ciprofol, a new choice of general anesthetic for thoracic surgery. ClinicalTrials.gov (NCT05664386).

Video-assisted thoracoscopic surgery (VATS) is used increasingly as an alternative to thoracotomy for lobectomy in the treatment of early-stage non-small-cell lung cancer, but remains controversial and worldwide adoption rates are low. Non-randomised studies have suggested that VATS reduces postoperative morbidity, but there is little high-quality evidence to show its superiority over open surgery. We aimed to investigate postoperative pain and quality of life in a randomised trial of patients with early-stage non-small-cell lung cancer undergoing VATS versus open surgery. We did a randomised controlled patient and observer blinded trial at a public university-based cardiothoracic surgery department in Denmark. We enrolled patients who were scheduled for lobectomy for stage I non-small-cell lung cancer. By use of a web-based randomisation system, we assigned patients (1:1) to lobectomy via four-port VATS or anterolateral thoracotomy. After surgery, we applied identical surgical dressings to ensure masking of patients and staff. Postoperative pain was measured with a numeric rating scale (NRS) six times per day during hospital stay and once at 2, 4, 8, 12, 26, and 52 weeks, and self-reported quality of life was assessed with the EuroQol 5 Dimensions (EQ5D) and the European Organisation for Research and Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30) during hospital stay and 2, 4, 8, 12, 26, and 52 weeks after discharge. The primary outcomes were the proportion of patients with clinically relevant moderate-to-severe pain (NRS ≥3) and mean quality of life scores. These outcomes were assessed longitudinally by logistic regression across all timepoints. Data for the primary analysis were analysed by modified intention to treat (ie, all randomised patients with pathologically confirmed non-small-cell lung cancer). This trial is registered with ClinicalTrials.gov, number NCT01278888. Between Oct 1, 2008, and Aug 20, 2014, we screened 772 patients, of whom 361 were eligible for inclusion and 206 were enrolled. We randomly assigned 103 patients to VATS and 103 to anterolateral thoracotomy. 102 patients in the VATS group and 99 in the thoracotomy group were included in the final analysis. The proportion of patients with clinically relevant pain (NRS ≥3) was significantly lower during the first 24 h after VATS than after anterolateral thoracotomy (VATS 38%, 95% CI 0·28–0·48 vs thoracotomy 63%, 95% CI 0·52–0·72, p=0·0012). During 52 weeks of follow-up, episodes of moderate-to-severe pain were significantly less frequent after VATS than after anterolateral thoracotomy (p<0·0001) and self-reported quality of life according to EQ5D was significantly better after VATS (p=0·014). By contrast, for the whole study period, quality of life according to QLQ-C30 was not significantly different between groups (p=0·13). Postoperative surgical complications (grade 3–4 adverse events) were similar between the two groups, consisting of prolonged air leakage over 4 days (14 patients in the VATS group vs nine patients in the thoracotomy group), re-operation for bleeding (two vs none), twisted middle lobe (one vs three) or prolonged air leakage over 7 days (five vs six), arrhythmia (one vs one), or neurological events (one vs two). Nine (4%) patients died during the follow-up period (three in the VATS group and six in the thoracotomy group). VATS is associated with less postoperative pain and better quality of life than is anterolateral thoracotomy for the first year after surgery, suggesting that VATS should be the preferred surgical approach for lobectomy in stage I non-small-cell lung cancer. Simon Fougner Hartmanns Familiefond, Guldsmed AL & D Rasmussens Mindefond, Karen S Jensens legat, The University of Southern Denmark, The Research Council at Odense University Hospital, and Department of Cardiothoracic Surgery, Odense University Hospital.

Abstract Rationale Endobronchial valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema. Objectives To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system. Methods Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, St. George’s Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction. Measurements and Main Results Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV1, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC group (n = 50). In the intention-to-treat population, at 3 months postprocedure, improvement in FEV1 from baseline was 13.7 ± 28.2% in the EBV group and −3.2 ± 13.0% in the SoC group (mean between-group difference, 17.0%; P = 0.0002). Other variables demonstrated statistically and clinically significant changes from baseline to 3 months (EBV vs. SoC, respectively: SGRQ, −8.63 ± 11.25 vs. 1.01 ± 9.36; and 6MWD, 22.63 ± 66.63 m vs. −17.34 ± 52.8 m). Target lobe volume reduction at 3 months was −1,195 ± 683 ml (P < 0.0001). Of the EBV subjects, 97.2% achieved volume reduction in the target lobe (P < 0.0001). Procedure-related pneumothoraces occurred in 11 subjects (25.6%). Five subjects required removal/replacement of one or more valves. One subject experienced two valve migration events requiring removal/replacement of valves. Conclusions EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.

BackgroundThis study aims to compare three commonly used energy devices for dissection during Video-Assisted Thoracoscopic Surgery (VATS) lobectomy: monopolar hook, advanced bipolar, and ultrasonic device, in terms of duration of the surgical procedure and clinical intra- and post-operative outcomes.Materials and methodsIn this prospective single-center study, 75 patients undergoing VATS lobectomy for non-small cell lung cancer between January 2022 and May 2023 were enrolled and divided into 3 groups based on the device used during the surgical procedure (Group 1: Ultrasonic Device, Group 2: Advanced Bipolar, Group 3: Monopolar Hook). The duration of the surgical procedure, daily pleural fluid production, post-operative pain, length of hospital stay, and occurrence of post-operative complications were compared for each group. In a subgroup of 20 patients (10 from Group 1 and 10 from Group 3), concentrations of inflammatory cytokines in pleural fluid at 3 h and 48 h post-surgery were analyzed.ResultsPleural fluid production on the first and second post-operative days was significantly lower in patients treated with the Ultrasonic device compared to the other two groups (p < 0.001). The duration of the surgical procedure was significantly shorter when using the Ultrasonic device (p < 0.001). There were no significant differences in length of hospital stay (p = 0.975), pain on the first and second post-operative days (p = 0.147 and p = 0.755, respectively), and blood hemoglobin levels on the first post-operative day (p = 0.709) and at discharge (p = 0.795). No differences were observed in terms of post-operative complications, although the incidence of post-operative cardiac arrhythmias was borderline significant (p = 0.096), with no cases of arrhythmias recorded in Group 1. IL-10 levels in pleural fluid of patients in Group 3 peaked at 3 h post-surgery, with a significant reduction at 48 h (p = 0.459).DiscussionThe use of the ultrasonic device during VATS lobectomy may reduce pleural fluid production and shorten the duration of the surgical procedure compared to using a monopolar hook or advanced bipolar device. The choice of energy device may influence the local inflammatory response, although further studies are needed to confirm these results.

To assess the clinical benefits of a 5th versus 4th intercostal incision in female patients undergoing uniportal video-assisted thoracoscopic surgery (VATS) lobectomy and lymphadenectomy, focusing on breast tissue preservation, pain, cosmetic outcomes, recovery, and surgical maneuverability. A retrospective analysis of 150 female lung cancer patients was conducted, divided into 4 and 5th intercostal incision groups ( n  = 75 each). Propensity score matching balanced baseline characteristics. Primary outcomes included breast tissue involvement, postoperative pain (VAS), cosmetic satisfaction (Likert scale), recovery time, surgical maneuverability, and complication rates. Statistical analysis used Mann-Whitney U and Chi-square tests for group comparisons and multivariable regression to adjust for confounders. The 5th intercostal incision significantly reduced breast tissue involvement (10.7 vs. 65.3%, p  < 0.01), postoperative pain (VAS: 4.8 vs. 7.2, p  < 0.01), and recovery time (5.9 vs. 8.4 days, p  < 0.05), while enhancing cosmetic satisfaction ( p  < 0.01) and improving access to upper pulmonary veins. Incision site infections were notably lower in the 5th intercostal group (2.7 vs. 10.7%, p  < 0.05). The 5th intercostal incision provides substantial clinical advantages in uniportal VATS for female patients, including reduced breast tissue involvement, minimized pain, enhanced cosmetic outcomes, and faster recovery. These findings support the 5th intercostal incision as a preferred approach in this patient population, aligning with precision surgery principles to optimize outcomes.