Scholarlink

Background <p>Malignant pleural effusion (MPE) causes debilitating dyspnea, severely impacting quality of life (QoL) among patients with advanced stage cancer. While talc pleurodesis effectively prevents recurrence, it requires lengthy hospital stays. Indwelling pleural catheters (IPC) offer outpatient management but are associated with slightly lower pleurodesis success rates and prolonged catheter presence. Given hospital capacity constraints, we evaluated the efficacy of combined thoracoscopic talc poudrage (TTP) and IPC versus TTP alone for symptomatic MPE.</p> Methods <p>This randomized, non-inferiority-controlled trial, conducted at King Chulalongkorn Memorial Hospital, randomly assigned 38 patients to receive either combined TTP + IPC or TTP alone. The primary outcome was 12-week pleurodesis success rate with a pre-specified non-inferiority margin of − 20%. Secondary outcomes included hospital length of stay (LOS), symptoms control, and QoL. The trial was registered with the Thai Clinical Trials Registry under the registration number TCTR20230312001 (retrospectively).</p> Results <p>Thirty-eight patients (19 per group) completed the study. Baseline characteristics were comparable, except for significantly worse dyspnea, chest tightness, and QoL scores in the TTP + IPC group. Successful 12-week pleurodesis was 89.5% for TTP + IPC versus 68.4% for TTP alone (difference 21.1%; 95% CI, − 4.0% to 46.1%), establishing non-inferiority as the lower bound exceeded the − 20% margin. The TTP + IPC group demonstrated a significantly greater reduction in dyspnea scores (− 6.39 vs. − 3.67, <i>p</i> &lt; 0.001) and shorter median hospital LOS (1 vs. 4 days, <i>p</i> &lt; 0.001). After adjusting for baseline imbalances (ANCOVA), dyspnea improvement at 6 weeks and EQ-5D-5&#xa0;L utility scores at 12 weeks remained significant, whereas the VAS QoL difference was attenuated. Complication rates did not differ significantly between groups.</p> Conclusion <p>TTP + IPC demonstrated non-inferiority to TTP alone regarding 12-week pleurodesis success, thereby preserving pleurodesis efficacy. Furthermore, the combined approach was associated with shorter hospitalizations and improvements in symptom burden; baseline-adjusted analyses confirmed robustness of some but not all patient-reported benefits.</p> Trial Registration <p>TCTR20230312001.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Combined indwelling pleural catheter with thoracoscopic talc poudrage for malignant pleural effusion management: a randomized non-inferiority trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月4日

查看全文
  • Jitanong Sootlek,
  • Nophol Leelayuwatanakul,
  • Virissorn Wongsrichanalai,
  • Thitiwat Sriprasart,
  • Vorawut Thanthitaweewat

摘要

Background

Malignant pleural effusion (MPE) causes debilitating dyspnea, severely impacting quality of life (QoL) among patients with advanced stage cancer. While talc pleurodesis effectively prevents recurrence, it requires lengthy hospital stays. Indwelling pleural catheters (IPC) offer outpatient management but are associated with slightly lower pleurodesis success rates and prolonged catheter presence. Given hospital capacity constraints, we evaluated the efficacy of combined thoracoscopic talc poudrage (TTP) and IPC versus TTP alone for symptomatic MPE.

Methods

This randomized, non-inferiority-controlled trial, conducted at King Chulalongkorn Memorial Hospital, randomly assigned 38 patients to receive either combined TTP + IPC or TTP alone. The primary outcome was 12-week pleurodesis success rate with a pre-specified non-inferiority margin of − 20%. Secondary outcomes included hospital length of stay (LOS), symptoms control, and QoL. The trial was registered with the Thai Clinical Trials Registry under the registration number TCTR20230312001 (retrospectively).

Results

Thirty-eight patients (19 per group) completed the study. Baseline characteristics were comparable, except for significantly worse dyspnea, chest tightness, and QoL scores in the TTP + IPC group. Successful 12-week pleurodesis was 89.5% for TTP + IPC versus 68.4% for TTP alone (difference 21.1%; 95% CI, − 4.0% to 46.1%), establishing non-inferiority as the lower bound exceeded the − 20% margin. The TTP + IPC group demonstrated a significantly greater reduction in dyspnea scores (− 6.39 vs. − 3.67, p < 0.001) and shorter median hospital LOS (1 vs. 4 days, p < 0.001). After adjusting for baseline imbalances (ANCOVA), dyspnea improvement at 6 weeks and EQ-5D-5 L utility scores at 12 weeks remained significant, whereas the VAS QoL difference was attenuated. Complication rates did not differ significantly between groups.

Conclusion

TTP + IPC demonstrated non-inferiority to TTP alone regarding 12-week pleurodesis success, thereby preserving pleurodesis efficacy. Furthermore, the combined approach was associated with shorter hospitalizations and improvements in symptom burden; baseline-adjusted analyses confirmed robustness of some but not all patient-reported benefits.

Trial Registration

TCTR20230312001.