Stukan Maciej, Jędryka Marcin, Cokan Andrej, Klát Jaroslav, Ndukwe Munachiso Iheme, Kryszpin Marcin, Poblocka Renata, Timošek Eva, Romanová Martina, Balcarová Klára, Madry Radoslaw, Cibula David
Department of Gynecological Oncology, Gdynia Oncology Center, Pomeranian Hospitals, Gdynia, Poland.
Surgical Oncology Clinic, Gdansk Medical University, Gdansk, Poland.
Support Care Cancer. 2025 Feb 19;33(3):202. doi: 10.1007/s00520-025-09265-4.
Malignant ascites (MA) and repeated paracentesis can impair a patient's quality of life (QOL). The aim was to perform an interim analysis of safety and changes in patients' QOL in an ongoing prospective, multicentre (conducted within the Central and Eastern European Gynaecologic Oncology Group (CEEGOG)) trial on symptomatic MA drainage with a patient-controlled central vascular catheter (CVC) inserted into the abdominal cavity. CVC (14-Ga) was inserted into the abdominal cavity of patients with symptomatic MA, and drainage was controlled by patients at home. The rate and quality of complications were classified according to Common Terminology Criteria for Adverse Events Version 5.0. QOL was evaluated before and 10-14 days after/during drainage with standardized QLQ-C15-PAL, SGA, and FACIT-TS-G questionnaires. Wilcoxon and Chi-squared tests were used. Among 113 recruited patients (2015-2022), seven patients experienced complications (6.2%), and there was one patient with a serious adverse event (death on the 9th day after catheter insertion, classified as not related to the intervention). Adverse events included local infection (n = 2) (resolved after oral antibiotics), catheter obstruction (n = 2), catheter self-removal (n = 2) (re-insertion performed), and nausea (n = 1). When comparing the assessment before and after/during drainage, we found the significantly better global QOL (mean 31.8 vs. 47.8, p < 0.001), improvement in physical (52.6 vs. 64.4, p < 0.001) and emotional functioning (50.7 vs. 65.4, p < 0.001); symptoms were significantly less intense: fatigue (66.7 vs. 50.9, p < 0.001), nausea and vomiting (37.8 vs. 21.4, p < 0.001), pain (53.9 vs. 34.1, p < 0.001), dyspnoea (48.5 vs. 22.3, p < 0.001), insomnia (49.1 vs. 34.3, p < 0.001), appetite loss (56.3 vs. 40.3, p < 0.001), and constipation (31.0 vs. 25.2, p = 0.007), and more patients had no pain on eating (71.3% vs. 82.9%, p = 0.04). Most patients (78%) were satisfied, 83% would recommend the procedure to others, and 90% would choose intervention again. The interim analysis provided data on the safety and improvement of patients' QOL after MA drainage via patient-controlled CVC inserted into the abdominal cavity, thus justifying the continuation of recruitment for the main trial without changes in the protocol.
恶性腹水（MA）和反复腹腔穿刺会损害患者的生活质量（QOL）。目的是在一项正在进行的前瞻性多中心试验（由中欧和东欧妇科肿瘤学组（CEEGOG）开展）中，对通过插入腹腔的患者自控中心静脉导管（CVC）进行有症状MA引流的安全性以及患者QOL的变化进行中期分析。将CVC（14-Ga）插入有症状MA患者的腹腔，引流由患者在家中控制。根据《不良事件通用术语标准》第5.0版对并发症的发生率和质量进行分类。在引流前以及引流后/引流期间10 - 14天，使用标准化的QLQ-C15-PAL、SGA和FACIT-TS-G问卷对QOL进行评估。采用Wilcoxon检验和卡方检验。在113例招募患者（2015 - 2022年）中，7例患者出现并发症（6.2%），1例患者发生严重不良事件（导管插入后第9天死亡，分类为与干预无关）。不良事件包括局部感染（n = 2）（口服抗生素后缓解）、导管阻塞（n = 2）、导管自行拔除（n = 2）（重新插入）以及恶心（n = 1）。比较引流前后/引流期间的评估结果时，我们发现总体QOL显著改善（均值31.8对47.8，p < 0.001），身体功能（52.6对64.4，p < 0.001）和情感功能（50.7对65.4，p < 0.001）有所改善；症状强度显著降低：疲劳（66.7对50.9，p < 0.001）、恶心和呕吐（37.8对21.4，p < 0.001）、疼痛（53.9对34.1，p < 0.001）、呼吸困难（48.5对22.3，p < 0.001）、失眠（49.1对34.3，p < 0.001）、食欲减退（56.3对40.3，p < 0.001）以及便秘（31.0对25.2，p = 0.007），并且更多患者进食时无疼痛（71.3%对82.9%，p = 0.04）。大多数患者（78%）感到满意，83%会向他人推荐该操作，90%会再次选择该干预措施。中期分析提供了关于通过插入腹腔的患者自控CVC进行MA引流后患者安全性和QOL改善的数据，从而证明在方案不变的情况下继续进行主要试验的招募是合理的。
