悪性胸水に対する胸腔鏡下 vs chest tubeによるタルク投与のRCT

Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions A Randomized Clinical Trial

JAMA. doi:10.1001/jama.2019.19997

The TAPPS (Evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry) trial

 

○PICO

P： Participants were required to be able to tolerate thoracoscopy with moderate sedation and have an estimated survival of longer than 3 months.

※MPE→either proven histocytologically, an unexplained effusion in the context of proven cancer, or suggested by pleural changes con- sistent with malignancy on cross-sectional imaging. 

I：the talc poudrage group (n = 166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation

C：the control group (n = 164) underwent bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry.

O：The primary outcome was pleurodesis failure up to 90 days after randomization.

※Pleurodesis failure was recorded if the patient underwent any of the following interventions on the same side as the trial intervention during the follow-up period: removal of ≥100 mL of fluid during thoracentesis (this threshold was chosen to distinguish between a low-volume diagnostic procedure and a higher-volume therapeutic procedure); chest tube insertion for fluid management; insertion of an indwelling pleural catheter; or thoracoscopy of any kind.

Secondary outcomes included pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life at 30, 90, and 180 days; all-cause mortality; and percentage of opacification on chest radiograph at drain removal and at 30, 90, and 180 days.

 

タルクの投与方法に対するRCT。事前の仮説は胸腔鏡による投与のほうがより効果的ではないか。

デザインはopen-labelであること、eligibilityを満たしたのに事前に設定した条件以外で多くの患者が除外を受けていたこと、control群でinclusion時にchemotherapyを受けている割合が多いことなど問題点は挙げられる。

結果はprimary, secondary outcomeを含めてすべて有意差なし。このRCTをもって胸腔鏡投与の優越性は示せなかった。

個人的な経験としてはchest tubeでの投与が主流でした。うまくいかない経験もあったため胸腔鏡で効果的であればよりいいかなと思っていました。