Study protocol for DICE trial: Video-assisted thoracoscopic surgery decortication versus interventional radiology guided chest tube insertion for the management of empyema

Williams, Erin; Hanna, Nader; Menard, Alex; Mussari, Benedetto; Nasirzadeh, Reza; Tarulli, Emidio; Dhillon, Gurmohan; Reid, Kathy; Petsikas, Dimitri; Pereira, Jennifer A.; Heffernan, Paul; Chung, Wiley

doi:10.1016/j.conctc.2021.100777

Cited by 2 publications

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“…This pilot trial is notable as it is one of the first to assess the feasibility, safety, and efficacy of a study algorithm comparing IPFT with surgical decortication for the management of a CPI. Ongoing trials across the globe and the MIST-3 assessing the feasibility of randomizing patients with CPI to early IPFT or VATS will add to the evidence base surrounding this clinical dilemma, but they remain exploratory in their design . We believe there remains a need and value in performing an appropriately powered multicenter randomized clinical trial within the US to better address care for this common and complex problem.…”

Section: Discussionmentioning

confidence: 99%

“…Ongoing trials across the globe 30 , 31 and the MIST-3 32 assessing the feasibility of randomizing patients with CPI to early IPFT or VATS will add to the evidence base surrounding this clinical dilemma, but they remain exploratory in their design. 33 We believe there remains a need and value in performing an appropriately powered multicenter randomized clinical trial within the US to better address care for this common and complex problem.…”

Section: Discussionmentioning

confidence: 99%

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Effect of Intrapleural Fibrinolytic Therapy vs Surgery for Complicated Pleural Infections

et al. 2023

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ImportanceThere is a paucity of high-quality prospective randomized clinical trials comparing intrapleural fibrinolytic therapy (IPFT) with surgical decortication in patients with complicated pleural infections.ObjectiveTo assess the feasibility, safety, and efficacy of an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections.Design, Setting, and ParticipantsThis parallel pilot randomized clinical trial was performed at a single urban community-based center from March 1, 2019, to December 31, 2021, with follow-up for 90 days. Seventy-four individuals were screened and 48 were excluded. Twenty-six patients 18 years or older with clinical pleural infection and positive findings of pleural fluid analysis were included. Of these, 20 patients underwent randomized selection (10 in each group), and 6 were observed.InterventionsIntrapleural tissue plasminogen activator plus deoxyribonuclease therapy vs surgical decortication.Main Outcomes and MeasuresPrimary outcomes were the percentage of patients enrolled to study completion and multidisciplinary adherence. Secondary outcomes included the number of patients with and the reason for inadequate screening, screening to enrollment failures, time to accrual of 20 patients or the number accrued at 1 year, and clinical data.ResultsTwenty-six patients were enrolled, 10 were randomized to each group, and 6 were observed. There was 100% enrollment to study completion in each treatment group, no protocol deviations, 2 minor protocol amendments, and no screening to enrollment failures. It took 32 months to enroll 26 patients. The 20 randomized patients had a median age of 57 (IQR, 46-65) years, were predominantly men (15 [75%]), and had a median RAPID (Renal, Age, Purulence, Infection Source, and Dietary Factors) score of 2 (IQR, 1-3). Treatment failure occurred in 1 patient and 2 crossover treatments occurred, all of which were in the IPFT group. Intraprocedure and postprocedure complications were similar between the groups. There were no reoperations or in-hospital deaths. Median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups (P = .21). Median hospital stay tended to be longer in the IPFT (11 [IQR, 4-18] days) vs surgery (5 [IQR, 4-6] days) groups, although the difference as not significantly different (P = .08). There were no 30-day readmissions or 30- or 90-day deaths.Conclusions and RelevanceIn this pilot randomized clinical trial, the study algorithm was feasible, safe, and efficacious. This provides evidence to move forward with a multicenter randomized clinical trial.Trial RegistrationClinicalTrials.gov Identifier: NCT03873766

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%