The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trial.

INTRODUCTION: Malignant pleural effusion (MPE) is common, with 50 000 new cases per year in the UK. MPE causes disabling breathlessness and indicates advanced disease with a poor prognosis. Treatment approaches focus on symptom relief and optimising quality of life (QoL). Patients who newly present with MPE commonly require procedural intervention for both diagnosis and therapeutic benefit.Thoracoscopic pleural biopsies are highly sensitive in diagnosing pleural malignancy. Talc poudrage may be delivered at thoracoscopy (TTP) to prevent effusion recurrence by effecting pleurodesis. Indwelling pleural catheters (IPCs) offer an alternative strategy for fluid control, enabling outpatient management and are often used as 'rescue' therapy following pleurodesis failure or in cases of 'trapped lung'. It is unknown whether combining a TTP with IPC insertion will improve patient symptoms or reduce time spent in the hospital.The randomised thoracoscopic talc poudrage + indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC) is the first randomised controlled trial (RCT) to examine the benefit of a combined TTP and IPC procedure, evaluating cost-effectiveness and patient-centred outcomes such as symptoms and QoL. The study remains in active recruitment and has the potential to radically transform the pathway for all patients presenting with MPE. METHODS AND ANALYSIS: TACTIC is an unblinded, multicentre, RCT comparing the combination of TTP with an IPC to TTP alone. Co-primary outcomes are time spent in the hospital and mean breathlessness score over 4 weeks postprocedure. The study will recruit 124 patients and aims to define the optimal pathway for patients presenting with symptomatic MPE. ETHICS AND DISSEMINATION: TACTIC is sponsored by North Bristol NHS Trust and has been granted ethical approval by the London-Brent Research Ethics Committee (REC ref: 21/LO/0495). Publication of results in a peer-reviewed journal and conference presentations are anticipated. TRIAL REGISTRATION: ISRCTN 11058680.

Diagnostic utility of endobronchial ultrasound guided transbronchial needle aspiration for mediastinal lesions: A prospective three year, single centre analysis.

BACKGROUND: The diagnostic yield of endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) over a 3-year period was analyzed. METHODS: Consecutive patients who underwent EBUS for the evaluation of pulmonary/mediastinal lesions were recruited. RESULTS: One hundred and ninety-one patients were studied (54% male, mean age, 65 years [standard deviation 11.1]). A final diagnosis of a malignant disorder was made in 151 patients (79%). Of these, EBUS-TBNA alone provided the diagnosis in 135 patients. The majority of the remaining 56 patients had reactive changes (n = 32). Nineteen patients, either because they did not respond to appropriate treatment or based on clinical indication, underwent a different procedure resulting in an additional diagnosis of malignancy in 16 patients, tuberculosis in one and indeterminate in two. The diagnostic yield of EBUS for malignant disorders was 70.7% (95% confidence interval (CI), 0.86, 0. 77). The overall ability of EBUS to achieve a definitive diagnosis (benign plus malignant) was 90.1% (95% CI, 0.85, 0. 94). Logistic regression and stepwise regression analysis revealed that older age, greater lymph node size, and the presence of intraprocedure complications significantly influenced EBUS yield for malignancy. CONCLUSION: EBUS-TBNA has a high diagnostic yield for mediastinal lesions, both benign and malignant. The yield depends on both lesion- and patient-related factors.

Performance characteristics of semirigid thoracoscopy in pleural effusions of undetermined etiology.

BACKGROUND: The utility of the recently introduced semirigid thoracoscopy in undiagnosed pleural effusions is still unclear. METHODS: A single-center, 4-year retrospective analysis of all semirigid medical thoracoscopy procedures was done. The diagnostic accuracy of thoracoscopy was calculated as the number of positive diagnoses achieved by thoracoscopy in relation to the end-diagnosis achieved in the patient group by any means. RESULTS: One hundred fifty procedures were analyzed. Ninety-two patients (62.3%) were diagnosed as having a malignant disorder, of which mesothelioma was the most common (26%). Pleural thickening and nodularity were the most common abnormalities noted. The combined presence of nodules and hemorrhagic fluid increased the likelihood of malignancy 9-fold. Thirteen patients with a high clinical suspicion of malignancy but negative by thoracoscopy underwent mediastinoscopy, computed tomography-guided biopsy, or open thoracotomy. A malignant etiology was confirmed in all of them. Overall, thoracoscopy provided a diagnostic accuracy of 91.3%, sensitivity of 87%, and specificity of 100%. The addition of a second procedure in selected patients improved the diagnostic accuracy for malignancy by 8.7%. The procedures were well tolerated and only 6 patients developed minor and transient complications such as pain, hypoxia, and bradycardia. CONCLUSION: Semirigid thoracoscopy is a safe, well-tolerated, and efficacious procedure for establishing the diagnosis in pleural effusions of undetermined etiology.