Hansen Pernille Schjødt, Graversen Martin, Detlefsen Sönke, Ainsworth Alan Patrick, Fristrup Claus Wilki, Eckhoff Lise, Jelin-Klaric Mia, Mortensen Michael Bau
Odense PIPAC Center (OPC) and Odense Pancreas Center (OPAC), Odense University Hospital, Odense, Denmark.
Department of Surgery, HPB and Upper GI Section, Odense University Hospital, Odense, Denmark.
Pleura Peritoneum. 2024 Nov 18;9(4):141-148. doi: 10.1515/pp-2024-0014. eCollection 2024 Dec.
Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) is a minimally invasive cancer-directed therapy for patients with malignant pleural effusion (MPE) and/or pleural metastasis (PLM). PITAC is based on Pressurized IntraPeritoneal Aerosol Chemotherapy, which has proven to be safe and feasible. Since 2012, 47 PITACs have been published, and prospective data on feasibility, safety and potential local response are lacking.
The prospective, controlled, phase-I study is designed to treat MPE with PITAC. There are no data to support the estimated number of patients needed, but previous experience estimates the non-access rate to 20 %. Twenty eligible patients with MPE will receive two or more PITACs at four-week intervals. During video-assisted thoracoscopy, MPE and/or pleural lavage fluid is evacuated, and the extent of visible PLM is assessed. Pleural biopsies are collected, if possible, for histological response as per Thoracic Regression Grading Score (TRGS). Patients are screened for treatment-related intra- and postoperative complications. The primary outcome is the number of patients with Clavien-Dindo ≥3b or Common Terminology Criteria for Adverse Events≥4 within 30 days. Secondary objectives include PLM-score, TRGS and cytology, length of hospitalization, personnel safety, quality of life, and change in MPE volume.
PITAC is expected to be safe and feasible for patients and personnel, and achieve positive results in the reduction of MPE volume.
The results may significantly impact the next clinical, technical, and scientific steps in the implementation of PITAC. Given the suboptimal treatment options for MPE and the seemingly promising results of PITAC, we find the implementation of PITAC ethically reasonable and sound.
胸腔内加压雾化化疗（PITAC）是一种针对恶性胸腔积液（MPE）和/或胸膜转移（PLM）患者的微创癌症导向治疗方法。PITAC基于腹腔内加压雾化化疗，已被证明是安全可行的。自2012年以来，已发表了47篇关于PITAC的文章，但缺乏关于可行性、安全性和潜在局部反应的前瞻性数据。
这项前瞻性、对照、I期研究旨在用PITAC治疗MPE。没有数据支持所需患者的估计数量，但以往经验估计非入组率为20%。20名符合条件的MPE患者将每隔四周接受两次或更多次PITAC治疗。在电视辅助胸腔镜检查期间，抽吸出MPE和/或胸腔灌洗液，并评估可见PLM的范围。如果可能，根据胸部消退分级评分（TRGS）收集胸膜活检组织以评估组织学反应。对患者进行治疗相关的术中及术后并发症筛查。主要结局是30天内出现Clavien-Dindo≥3b级或不良事件通用术语标准≥4级的患者数量。次要目标包括PLM评分、TRGS和细胞学、住院时间、人员安全性、生活质量以及MPE体积的变化。
预计PITAC对患者和工作人员来说是安全可行的，并在减少MPE体积方面取得积极成果。
这些结果可能会对PITAC实施过程中的下一步临床、技术和科学步骤产生重大影响。鉴于MPE的治疗选择并不理想，而PITAC的结果似乎很有前景，我们认为从伦理角度来看，实施PITAC是合理且可靠的。
