Momen M Wahidi1, Chakravarthy Reddy2, Lonny Yarmus3, David Feller-Kopman3, Ali Musani4, R Wesley Shepherd5, Hans Lee3, Rabih Bechara6, Carla Lamb7, Scott Shofer1, Kamran Mahmood1, Gaetane Michaud8, Jonathan Puchalski9, Samaan Rafeq10, Stephen M Cattaneo11, John Mullon12, Steven Leh13, Martin Mayse14, Samantha M Thomas15, Bercedis Peterson15, Richard W Light16. 1. 1 Division of Pulmonary Medicine, Department of Medicine, Duke University, Durham, North Carolina. 2. 2 University of Utah, Salt Lake City, Utah. 3. 3 Johns Hopkins University, Baltimore, Maryland. 4. 4 Medical College of Wisconsin, Milwaukee, Wisconsin. 5. 5 Virginia Commonwealth University, Richmond, Virginia. 6. 6 Cancer Treatment Centers of America/Southeastern, Newnan, Georgia. 7. 7 Lahey Hospital and Medical Center, Burlington, Massachusetts. 8. 8 New York University, New York, New York. 9. 9 Yale University, New Haven, Connecticut. 10. 10 Saint Elizabeth Medical Center, Boston, Massachusetts. 11. 11 Division of Thoracic Surgery, Department of Surgery, Anne Arundel Health System, Annapolis, Maryland. 12. 12 Mayo Clinic, Rochester, Minnesota. 13. 13 Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin. 14. 14 Holaira, Inc., Minneapolis, Minnesota. 15. 15 Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina; and. 16. 16 Vanderbilt University, Nashville, Tennessee.
Abstract
RATIONALE: Patients with malignant pleural effusions have significant dyspnea and shortened life expectancy. Indwelling pleural catheters allow patients to drain pleural fluid at home and can lead to autopleurodesis. The optimal drainage frequency to achieve autopleurodesis and freedom from catheter has not been determined. OBJECTIVES: To determine whether an aggressive daily drainage strategy is superior to the current standard every other day drainage of pleural fluid in achieving autopleurodesis. METHODS: Patients were randomized to either an aggressive drainage (daily drainage; n = 73) or standard drainage (every other day drainage; n = 76) of pleural fluid via a tunneled pleural catheter. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the incidence of autopleurodesis following the placement of the indwelling pleural catheters. The rate of autopleurodesis, defined as complete or partial response based on symptomatic and radiographic changes, was greater in the aggressive drainage arm than the standard drainage arm (47% vs. 24%, respectively; P = 0.003). Median time to autopleurodesis was shorter in the aggressive arm (54 d; 95% confidence interval, 34-83) as compared with the standard arm (90 d; 95% confidence interval, 70 to nonestimable). Rate of adverse events, quality of life, and patient satisfaction were not significantly different between the two arms. CONCLUSIONS: Among patients with malignant pleural effusion, daily drainage of pleural fluid via an indwelling pleural catheter led to a higher rate of autopleurodesis and faster time to liberty from catheter. Clinical trial registered with www.clinicaltrials.gov (NCT 00978939).
RCT Entities:
RATIONALE: Patients with malignant pleural effusions have significant dyspnea and shortened life expectancy. Indwelling pleural catheters allowpatients to drain pleural fluid at home and can lead to autopleurodesis. The optimal drainage frequency to achieve autopleurodesis and freedom from catheter has not been determined. OBJECTIVES: To determine whether an aggressive daily drainage strategy is superior to the current standard every other day drainage of pleural fluid in achieving autopleurodesis. METHODS:Patients were randomized to either an aggressive drainage (daily drainage; n = 73) or standard drainage (every other day drainage; n = 76) of pleural fluid via a tunneled pleural catheter. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the incidence of autopleurodesis following the placement of the indwelling pleural catheters. The rate of autopleurodesis, defined as complete or partial response based on symptomatic and radiographic changes, was greater in the aggressive drainage arm than the standard drainage arm (47% vs. 24%, respectively; P = 0.003). Median time to autopleurodesis was shorter in the aggressive arm (54 d; 95% confidence interval, 34-83) as compared with the standard arm (90 d; 95% confidence interval, 70 to nonestimable). Rate of adverse events, quality of life, and patient satisfaction were not significantly different between the two arms. CONCLUSIONS: Among patients with malignant pleural effusion, daily drainage of pleural fluid via an indwelling pleural catheter led to a higher rate of autopleurodesis and faster time to liberty from catheter. Clinical trial registered with www.clinicaltrials.gov (NCT 00978939).
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