Symptomatic Malignant Ascites Drainage with a Patient-controlled Vascular Catheter – interim analysis of safety and patients’ reported outcomes

Abstract Malignant ascites (MA) and repeated paracentesis can impair patient’s quality of life (QOL). The aim was to evaluate changes in patients’ QOL and the safety of MA drainage with a patient-controlled central vascular catheter (CVC) inserted into the abdominal cavity. This is an interim analysis of a prospective, multicentre trial ongoing within the Central and Eastern European Gynaecologic Oncology Group (CEEGOG). 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) 8 adverse events were detected in 7 patients (6.2%), including one serious (death on the 9th day after catheter insertion, classified as not related to the intervention). Other complications were 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 quality of life (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), 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. MA drainage via patient-controlled CVC inserted into the abdominal cavity is safe and improves patients’ QOL.