Am J Respir Crit Care Med. 2023 Oct 11. doi: 10.1164/rccm.202305-0854OC. Online ahead of print.
ABSTRACT
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 non-surgery trial as well as the key outcome measures which are important to identify relevant patient-centered outcomes in a RCT.
METHODS: MIST-3 was a prospective multicenter RCT. All-comers with a confirmed diagnosis of pleural infection were enrolled and those with ongoing pleural sepsis after up to 24-hours of standard care were randomized to one of 3 arms; continued standard care, IET, or surgical opinion for VATS. The analysis was by intention to treat, despite some participants in the VATS arm not being fit enough to undergo surgical intervention.
MAIN RESULTS: Of 97 eligible patients, 60 (62%) participants were randomized. Despite a difference in time-to-intervention, length of stay was similar in both arms. There were no significant inter-group differences in 2-month readmission and further intervention. Compared to VATS, IET demonstrated a greater improvement in mean EQ-5D-5L health utility index at 2 months from baseline.
CONCLUSION: This is the first multicenter RCT of early IET vs early surgery in pleural infection. Despite logistical challenges posed by the COVID-19 pandemic, the study met its predefined feasibility criteria. Potential shortening of LOS with early surgery, and signals toward earlier resolution of pain and shortened recovery with IET were demonstrated. The study findings suggest that a definitive study is feasible and required to assess optimal initial management. Clinical trial registration available at www.isrctn.com, ID: ISRCTN18192121.
PMID:37820359 | DOI:10.1164/rccm.202305-0854OC
