Comparing the Success Rate of Pleurodesis with Thoracoscopic Talc Poudrage Combined with Indwelling Pleural Catheter versus Thoracoscopic Talc Poudrage in Patient with Malignant Pleural Effusion, A Randomized, Non-inferiority Clinical Trial

Abstract

Background: Malignant pleural effusion (MPE) can cause dyspnea symptoms that greatly impact a patient's quality of life. Talc pleurodesis or indwelling pleural catheter (IPC) insertion are two treatment options that can prevent recurrent MPE, alleviate dyspnea, and improve quality of life. However, talc pleurodesis requires a lengthy hospital stay, while IPC insertion is associated with lower pleurodesis success rates. Due to limited hospital bed capacity, we have devised a practical approach to managing MPE by combining TTP and IPC.

Objective: This study aims to evaluate the efficacy of combined Thoracoscopic talc poudrage (TTP) and IPC compared to TTP alone in patients with symptomatic MPE. Methods: The study was conducted as a randomized non-inferiority trial at a single center. Patients were randomly allocated to receive either TTP and IPC or TTP alone. The study collected demographic data, hospital length of stay (LOS), symptoms, and pleurodesis success rates. The primary outcome of the study was the success rate of pleurodesis at 12 weeks post-procedure. Results: Preliminary data analysis from 26 patients with a mean age of 61 years showed that the baseline characteristics were similar between the two groups, except for the baseline mean VAS dyspnea score, which was significantly higher in the TTP+IPC group. Successful pleurodesis at 12 weeks was achieved in 88.89% of the TTP+IPC group and 64.29% of the TTP alone group, with a difference of 24.6% [95% CI, -7.83% to 57.03%]. Additionally, the TTP+IPC group showed a greater reduction in dyspnea, less pain following the procedure, and less analgesic medication use. The hospital LOS was also shorter, and the overall quality of life was significantly better. Furthermore, there was no difference in the incidence of complications between the two groups. Conclusion: Combining thoracoscopic talc pleurodesis and IPC is both effective and safe for treating symptomatic MPE patients.