T. Batchelor

Prophylactic radiotherapy for the prevention of procedure-tract metastases after surgical and large-bore pleural procedures in malignant pleural mesothelioma (SMART): a multicentre, open-label, phase 3, randomised controlled trial

Summary Background The use of prophylactic radiotherapy to prevent procedure-tract metastases (PTMs) in malignant pleural mesothelioma remains controversial, and clinical practice varies worldwide. We aimed to compare prophylactic radiotherapy with deferred radiotherapy (given only when a PTM developed) in a suitably powered trial. Methods We did a multicentre, open-label, phase 3, randomised controlled trial in 22 UK hospitals of patients with histocytologically proven mesothelioma who had undergone large-bore pleural interventions in the 35 days prior to recruitment. Eligible patients were randomised (1:1), using a computer-generated sequence, to receive immediate radiotherapy (21 Gy in three fractions within 42 days of the pleural intervention) or deferred radiotherapy (same dose given within 35 days of PTM diagnosis). Randomisation was minimised by histological subtype, surgical versus non-surgical procedure, and pleural procedure (indwelling pleural catheter vs other). The primary outcome was the incidence of PTM within 7 cm of the site of pleural intervention within 12 months from randomisation, assessed in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN72767336. Findings Between Dec 23, 2011, and Aug 4, 2014, we randomised 203 patients to receive immediate radiotherapy (n=102) or deferred radiotherapy (n=101). The patients were well matched at baseline. No significant difference was seen in PTM incidence in the immediate and deferred radiotherapy groups (nine [9%] vs 16 [16%]; odds ratio 0·51 [95% CI 0·19–1·32]; p=0·14). The only serious adverse event related to a PTM or radiotherapy was development of a painful PTM within the radiotherapy field that required hospital admission for symptom control in one patient who received immediate radiotherapy. Common adverse events of immediate radiotherapy were skin toxicity (grade 1 in 50 [54%] and grade 2 in four [4%] of 92 patients vs grade 1 in three [60%] and grade 2 in two [40%] of five patients in the deferred radiotherapy group who received radiotherapy for a PTM) and tiredness or lethargy (36 [39%] in the immediate radiotherapy group vs two [40%] in the deferred radiotherapy group) within 3 months of receiving radiotherapy. Interpretation Routine use of prophylactic radiotherapy in all patients with mesothelioma after large-bore thoracic interventions is not justified. Funding Research for Patient Benefit Programme from the UK National Institute for Health Research.

Pain and recovery are comparable after either uniportal or multiport video-assisted thoracoscopic lobectomy: an observation study.

OBJECTIVES Uniportal approaches to video-assisted thoracoscopic surgery (VATS) lobectomy have been described in significant series. Few comparison studies between the two techniques exist. The aim was to determine whether the uniportal technique had more favourable postoperative outcomes than the multiport technique. METHODS All VATS lobectomies undertaken at a single university hospital during August 2012 to December 2013 were studied. Patients with preoperative opiate use or chronic pain were excluded. Patients were divided into those with uniportal and multiport approaches for analysis. All continuous data were assessed for normality, and analysed with the Mann-Whitney U-tests or t-tests as appropriate. Categorical data were analysed by Fishers exact or χ(2) test for trend as appropriate. RESULTS One hundred and twenty-nine VATS lobectomies were completed. Six were excluded and data were incomplete for 13, leaving 110 (15 uniportal, 95 multiport) for analysis. The demographics of the two groups were similar. There was no significant difference in the Thoracoscore or American Society of Anesthesiologists grades. The median morphine use in the first 24 postoperative hours was 19 mg in the uniportal group and 23 mg in the multiport group, P = 0.84. The median visual analogue pain score in the first 24 h was 0 in the uniportal group and 0 in the multiport group, P = 0.65. There was no difference in the duration of patient-controlled analgesia (P = 0.97), chest drain duration (P = 0.67) or hospital length of stay (P = 0.54). There was no inpatient mortality and no unplanned admission to critical care in either group. CONCLUSIONS Uniportal VATS lobectomy is safe, and there is no appreciable negative impact on the hospital stay or morbidity. Patient-reported pain and morphine use in the first 24 h was low with either technique. Larger prospective studies are needed to quantify any benefit to a particular approach for VATS lobectomy.

Protocol for the surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial): an RCT evaluating whether prophylactic radiotherapy reduces the incidence of procedure tract metastases

Introduction Patients with malignant pleural mesothelioma (MPM) may develop painful ‘procedure tract metastasis’ (PTM) at the site of previous pleural interventions. Prophylactic radiotherapy has been used to minimise this complication; however, three small randomised trials have shown conflicting results regarding its effectiveness. The surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial) is a suitably powered, multicentre, randomised controlled trial, designed to evaluate the efficacy of prophylactic radiotherapy within 42 days of pleural instrumentation in preventing the development of PTM in MPM. Methods and analysis 203 patients with a histocytologically proven diagnosis of MPM, who have undergone a large bore pleural intervention (thoracic surgery, large bore chest drain, indwelling pleural catheter or local anaesthetic thoracoscopy) in the previous 35 days, will be recruited from UK hospitals. Patients will be randomised (1:1) to receive immediate radiotherapy (21 Gy in 3 fractions over 3 working days within 42 days of the pleural intervention) or deferred radiotherapy (21 Gy in 3 fractions over 3 working days given if a PTM develops). Patients will be followed up for 12 months. The primary outcome measure is the rate of PTM until death or 12 months (whichever is sooner), as defined by the presence of a clinically palpable nodule of at least 1 cm diameter felt within 7 cm of the margins of the procedure site as confirmed by two assessors. Secondary outcome measures include chest pain, quality of life, analgaesic requirements, healthcare utilisation and safety (including radiotherapy toxicity). Ethics and dissemination The trial has received ethical approval from the Southampton B Research Ethics Committee (11/SC/0408). There is a Trial Steering Committee, including independent members and a patient and public representative. The trial results will be published in a peer-reviewed journal and presented at international conferences. Trial registration number ISRCTN72767336.

The impact of enhanced recovery after surgery (ERAS) protocol compliance on morbidity from resection for primary lung cancer

Objective: The adoption of Enhanced Recovery After Surgery programs in thoracic surgery is relatively recent with limited outcome data. This study aimed to determine the impact of an Enhanced Recovery After Surgery pathway on morbidity and length of stay in patients undergoing lung resection for primary lung cancer. Methods: This prospective cohort study collected data on consecutive patients undergoing lung resection for primary lung cancer between April 2012 and June 2014 at a regional referral center in the United Kingdom. All patients followed a standardized, 15‐element Enhanced Recovery After Surgery protocol. Key data fields included protocol compliance with individual elements, pathophysiology, and operative factors. Thirty‐day morbidity was taken as the primary outcome measure and classified a priori according to the Clavien‐Dindo system. Logistic regression models were devised to identify independent risk factors for morbidity and length of stay. Results: A total of 422 consecutive patients underwent lung resection over a 2‐year period, of whom 302 (71.6%) underwent video‐assisted thoracoscopic surgery. Lobectomy was performed in 297 patients (70.4%). Complications were experienced by 159 patients (37.6%). The median length of stay was 5 days (range, 1‐67), and 6 patients (1.4%) died within 30 days of surgery. There was a significant inverse relationship between protocol compliance and morbidity after adjustment for confounding factors (odds ratio, 0.72; 95% confidence interval, 0.57‐0.91; P < .01). Age, lobectomy or pneumonectomy, more than 1 resection, and delayed mobilization were independent predictors of morbidity. Age, lack of preoperative carbohydrate drinks, planned high dependency unit/intensive therapy unit admission, delayed mobilization, and open approach were independent predictors of delayed discharge (length of stay >5 days). Conclusions: Increased compliance with an Enhanced Recovery After Surgery pathway is associated with improved clinical outcomes after resection for primary lung cancer. Several elements, including early mobilization, appear to be more influential than others.

A Novel Cause of Acute Coronary Syndrome Due to Dynamic Extrinsic Coronary Artery Compression by a Rib Exostosis: Multimodality Imaging Diagnosis

We report a case of acute coronary syndrome secondary to intermittent extrinsic compression of the left anterior descending coronary artery by inward-pointing rib exostosis in an 18-year-old woman during forceful repeated expiration in labour. The diagnosis was achieved using multimodality noninvasive cardiac imaging. In particular, we demonstrated the novel role of expiratory-phase cardiac computed tomography in confirming the anatomical relationship of the bony exostosis to the left anterior descending coronary artery. The case reminds us the heart and mediastinum move dynamically, relative to the bony thorax, throughout the respiratory cycle, and that changes in cardiac physiology in pregnancy may become pathological.

Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS®) Society and the European Society of Thoracic Surgeons (ESTS)

Enhanced recovery after surgery is well established in specialties such as colorectal surgery. It is achieved through the introduction of multiple evidence-based perioperative measures that aim to diminish postoperative organ dysfunction while facilitating recovery. This review aims to present consensus recommendations for the optimal perioperative management of patients undergoing thoracic surgery (principally lung resection). A systematic review of meta-analyses, randomized controlled trials, large non-randomized studies and reviews was conducted for each protocol element. Smaller prospective and retrospective cohort studies were considered only when higher-level evidence was unavailable. The quality of the evidence base was graded by the authors and used to form consensus recommendations for each topic. Development of these recommendations was endorsed by the Enhanced Recovery after Surgery Society and the European Society for Thoracic Surgery. Recommendations were developed for a total of 45 enhanced recovery items covering topics related to preadmission, admission, intraoperative care and postoperative care. Most are based on good-quality studies. In some instances, good-quality data were not available, and subsequent recommendations are generic or based on data extrapolated from other specialties. In other cases, no recommendation can currently be made because either equipoise exists or there is a lack of available evidence. Recommendations are based not only on the quality of the evidence but also on the balance between desirable and undesirable effects. Key recommendations include preoperative counselling, nutritional screening, smoking cessation, prehabilitation for high-risk patients, avoidance of fasting, carbohydrate loading, avoidance of preoperative sedatives, venous thromboembolism prophylaxis, prevention of hypothermia, short-acting anaesthetics to facilitate early emergence, regional anaesthesia, nausea and vomiting control, opioid-sparing analgesia, euvolemic fluid management, minimally invasive surgery, early chest drain removal, avoidance of urinary catheters and early mobilization after surgery. These guidelines outline recommendations for the perioperative management of patients undergoing lung surgery based on the best available evidence. As the recommendation grade for most of the elements is strong, the use of a systematic perioperative care pathway has the potential to improve outcomes after surgery.