دورية أكاديمية
Early Video-assisted Thoracoscopic Surgery or Intrapleural Enzyme Therapy in Pleural Infection: A Feasibility Randomized Controlled Trial. The Third Multicenter Intrapleural Sepsis Trial-MIST-3.
| العنوان: | Early Video-assisted Thoracoscopic Surgery or Intrapleural Enzyme Therapy in Pleural Infection: A Feasibility Randomized Controlled Trial. The Third Multicenter Intrapleural Sepsis Trial-MIST-3. |
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| المؤلفون: | Bedawi EO; Oxford Respiratory Trials Unit, Nuffield Department of Medicine.; National Institute for Health and Care Research Oxford Biomedical Research Centre.; Oxford Centre for Respiratory Medicine and.; Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.; Academic Directorate of Respiratory Medicine., Stavroulias D; Department of Cardiothoracic Surgery, John Radcliffe Hospital, Oxford University Hospitals National Health Service (NHS) Foundation Trust, Oxford, United Kingdom., Hedley E; Oxford Respiratory Trials Unit, Nuffield Department of Medicine., Blyth KG; School of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom.; Department of Respiratory Medicine, Queen Elizabeth University Hospital, Glasgow, United Kingdom., Kirk A; Department of Thoracic Surgery, Golden Jubilee National Hospital, Glasgow, United Kingdom., De Fonseka D; Academic Directorate of Respiratory Medicine., Edwards JG; Department of Thoracic Surgery, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom., Internullo E; Department of Thoracic Surgery, Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom., Corcoran JP; Department of Respiratory Medicine and., Marchbank A; Department of Cardiothoracic Surgery, Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom., Panchal R; Department of Respiratory Medicine, Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom., Caruana E; Department of Thoracic Surgery, Glenfield Hospitals, University Hospitals of Leicester, Leicester, United Kingdom., Kadwani O; Department of Respiratory Medicine and., Okiror L; Department of Thoracic Surgery, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom., Saba T; Department of Respiratory Medicine and., Purohit M; Department of Cardiothoracic Surgery, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom., Mercer RM; Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom., Taberham R; Department of Cardiothoracic Surgery, John Radcliffe Hospital, Oxford University Hospitals National Health Service (NHS) Foundation Trust, Oxford, United Kingdom., Kanellakis N; Oxford Respiratory Trials Unit, Nuffield Department of Medicine.; National Institute for Health and Care Research Oxford Biomedical Research Centre.; Laboratory of Pleural and Lung Cancer Translational Research.; Chinese Academy of Medical Sciences Oxford Institute, Nuffield Department of Medicine, and., Condliffe AM; Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.; Academic Directorate of Respiratory Medicine., Lewis LG; Academic Directorate of Respiratory Medicine., Addala DN; Oxford Respiratory Trials Unit, Nuffield Department of Medicine.; National Institute for Health and Care Research Oxford Biomedical Research Centre.; Oxford Centre for Respiratory Medicine and., Asciak R; Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom., Banka R; Department of Respiratory Medicine, PD Hinduja National Hospital, Mumbai, India., George V; Department of Respiratory and Sleep Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.; Hunter Medical Research Institute, Newcastle, New South Wales, Australia., Hassan M; Chest Diseases Department, Alexandria University, Alexandria, Egypt., McCracken D; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland., Sundaralingam A; Oxford Respiratory Trials Unit, Nuffield Department of Medicine.; Oxford Centre for Respiratory Medicine and., Wrightson JM; Oxford Respiratory Trials Unit, Nuffield Department of Medicine.; Oxford Centre for Respiratory Medicine and., Dobson M; Oxford Respiratory Trials Unit, Nuffield Department of Medicine.; National Institute for Health and Care Research Oxford Biomedical Research Centre., West A; Department of Respiratory Medicine and., Barnes G; Patient representative, Oxford, United Kingdom., Harvey J; Department of Respiratory Medicine, North Bristol NHS Trust, Bristol, United Kingdom.; Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom., Slade M; Department of Respiratory Medicine, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, United Kingdom; and., Chester-Jones M; Oxford Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom., Dutton S; Oxford Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom., Miller RF; Institute for Global Health, University College London, London, United Kingdom., Maskell NA; Department of Respiratory Medicine, North Bristol NHS Trust, Bristol, United Kingdom.; Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom., Belcher E; Department of Cardiothoracic Surgery, John Radcliffe Hospital, Oxford University Hospitals National Health Service (NHS) Foundation Trust, Oxford, United Kingdom., Rahman NM; Oxford Respiratory Trials Unit, Nuffield Department of Medicine.; National Institute for Health and Care Research Oxford Biomedical Research Centre.; Laboratory of Pleural and Lung Cancer Translational Research.; Chinese Academy of Medical Sciences Oxford Institute, Nuffield Department of Medicine, and.; Oxford Centre for Respiratory Medicine and. |
| المصدر: | American journal of respiratory and critical care medicine [Am J Respir Crit Care Med] 2023 Dec 15; Vol. 208 (12), pp. 1305-1315. |
| نوع المنشور: | Randomized Controlled Trial; Clinical Trial, Phase III; Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Thoracic Society Country of Publication: United States NLM ID: 9421642 Publication Model: Print Cited Medium: Internet ISSN: 1535-4970 (Electronic) Linking ISSN: 1073449X NLM ISO Abbreviation: Am J Respir Crit Care Med Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2000- : New York, NY : American Thoracic Society Original Publication: New York, NY : American Lung Association, c1994- |
| مواضيع طبية MeSH: | Communicable Diseases*/etiology , Pleural Diseases* , Sepsis*/drug therapy , Sepsis*/surgery , Sepsis*/etiology, Humans ; Thoracic Surgery, Video-Assisted/adverse effects ; Feasibility Studies ; Enzyme Therapy |
| مستخلص: | Rationale: Assessing the early use of video-assisted thoracoscopic surgery (VATS) or intrapleural enzyme therapy (IET) in pleural infection requires a phase III randomized controlled trial (RCT). Objectives: To establish the feasibility of randomization in a surgery-versus-nonsurgery trial as well as the key outcome measures that are important to identify relevant patient-centered outcomes in a subsequent RCT. Methods: The MIST-3 (third Multicenter Intrapleural Sepsis Trial) was a prospective multicenter RCT involving eight U.K. centers combining on-site and off-site surgical services. The study enrolled all patients with a confirmed diagnosis of pleural infection and randomized those with ongoing pleural sepsis after an initial period (as long as 24 h) of standard care to one of three treatment arms: continued standard care, early IET, or a surgical opinion with regard to early VATS. The primary outcome was feasibility based on >50% of eligible patients being successfully randomized, >95% of randomized participants retained to discharge, and >80% of randomized participants retained to 2 weeks of follow-up. The analysis was performed per intention to treat. Measurements and Main Results: Of 97 eligible patients, 60 (62%) were randomized, with 100% retained to discharge and 84% retained to 2 weeks. Baseline demographic, clinical, and microbiological characteristics of the patients were similar across groups. Median times to intervention were 1.0 and 3.5 days in the IET and surgery groups, respectively ( P = 0.02). Despite the difference in time to intervention, length of stay (from randomization to discharge) was similar in both intervention arms (7 d) compared with standard care (10 d) ( P = 0.70). There were no significant intergroup differences in 2-month readmission and further intervention, although the study was not adequately powered for this outcome. Compared with VATS, IET demonstrated a larger improvement in mean EuroQol five-dimension health utility index (five-level edition) from baseline (0.35) to 2 months (0.83) ( P = 0.023). One serious adverse event was reported in the VATS arm. Conclusions: This is the first multicenter RCT of early IET versus early surgery in pleural infection. Despite the logistical challenges posed by the coronavirus disease (COVID-19) pandemic, the study met its predefined feasibility criteria, demonstrated potential shortening of length of stay with early surgery, and signals toward earlier resolution of pain and a shortened recovery with IET. The study findings suggest that a definitive phase III study is feasible but highlights important considerations and significant modifications to the design that would be required to adequately assess optimal initial management in pleural infection.The trial was registered on ISRCTN (number 18,192,121). |
| التعليقات: | Comment in: Am J Respir Crit Care Med. 2023 Dec 15;208(12):1261-1263. doi: 10.1164/rccm.202310-1822ED. (PMID: 37934466) |
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| معلومات مُعتمدة: | PG-PB-0416-20020 Research for Patient Benefit Programme |
| فهرسة مساهمة: | Keywords: intrapleural; pleural effusion; pleural empyema; randomized controlled trial; video-assisted thoracic surgery |
| تواريخ الأحداث: | Date Created: 20231011 Date Completed: 20231216 Latest Revision: 20240731 |
| رمز التحديث: | 20240731 |
| مُعرف محوري في PubMed: | PMC10765402 |
| DOI: | 10.1164/rccm.202305-0854OC |
| PMID: | 37820359 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1535-4970 |
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| DOI: | 10.1164/rccm.202305-0854OC |