Trans-arterial radioembolization (TARE) is established as a treatment for colorectal liver metastases and may also be beneficial in other tumour entities. This prospective analysis aimed to evaluate the safety and effectiveness of TARE in patients with liver metastases of non-colorectal origin. Data were extracted from the prospective, multicentre, observational CIRSE Registry for SIR-Spheres Therapy (CIRT). Adult patients with liver metastases of non-colorectal origin, including neuroendocrine tumours (NET), breast cancer, pancreatic cancer and melanoma treated with TARE Yttrium-90 resin microspheres, were included. Safety and survival analyses were conducted. Assessment for independent prognostic factors was conducted using Cox proportional hazards models. Adverse events were defined according to the CTCAE 4.03. A total of 169 patients underwent TARE: NET (n = 58), breast cancer (n = 47), pancreatic cancer (n = 32), and melanoma (n = 32) with median follow-up of 19.3, 9.6, 5.6 and 14.8 months, respectively. Median overall survival (OS) was 33.3 (22.4-NA), 10.7 (7.7–16.3), 5.6 (4.9–10.1), 14.7 (8.7–27) months, for the NET, breast cancer, pancreatic cancer and melanoma cohorts, respectively. Overall, severe adverse events (grade ≥ 3) occurred in 10
Importance:Albumin supplementation may reduce mortality in patients with septic shock; however, data from randomized clinical trials are limited. Objective:To assess the impact of albumin administration on outcomes in patients with septic shock. Design, Setting, and Participants:This multicenter, open-label randomized clinical trial was conducted between October 21, 2019, and May 2, 2022. Patients from 23 intensive care units in Germany enrolled within 24 hours of the onset of septic shock were followed up for outcome data up to 90 days. The statistical trial report was completed and filed with the federal authorities in December 2023; additional analyses were completed in October 2024. The study was terminated prematurely due to low enrollment rates. Interventions:Protocol group patients received 20% albumin to maintain serum albumin levels of at least 3.0 g/dL for up to 28 days during their intensive care unit admission. The control group received standard fluid administration with crystalloids. Main Outcomes and Measures:The primary end point was 90-day mortality; secondary end points included 28-day, 60-day, intensive care unit and in-hospital mortality, organ dysfunction or failure, total amount of fluid administration and total fluid balance while in the intensive care unit, duration of intensive care and hospital stays, and frequency of adverse events. Results:Of 440 randomized patients (median [IQR] age, 69 [59-78] years; 290 [65.9%] male), 222 received albumin and 218 received standard fluids. Baseline characteristics were comparable. Ninety-day mortality was 43.3% (91 of 210) in the albumin group vs 45.9% (96 of 209) in controls (relative risk, 0.94; 95% CI, 0.76-1.17; P = .71). No significant differences were observed for secondary end points. Conclusions and Relevance:In this randomized clinical trial of patients with septic shock, albumin administration was safe but did not improve 90-day survival. As this trial was prematurely terminated, results remain inconclusive and additional studies are recommended. Trial Registration:ClinicalTrials.gov Identifier: NCT03869385.
To evaluate 2-year longitudinal patient-reported outcomes from a multisite, prospective observational study involving a real-world German cohort with mechanical chronic low back pain (CLBP) implanted with restorative neurostimulation. Patients with refractory, predominantly nociceptive, mechanical CLBP associated with lumbar multifidus dysfunction (N=87) consented to undergo restorative neurostimulation therapy implantation through five German clinics. Outcomes measures for pain (Numeric Pain Rating Scale), disability (Oswestry Disability Index-ODI), and quality of life (Euroqol’s EQ-5D) were collected at 90 and 180 days, one year, and two years from therapy activation. The painDETECT scale assessed the likelihood of mixed pain presentation. Sub-cohorts of painDETECT scores ≥19 (High) and <19 (Low) were compared on outcomes to assess mixed pain response. Among patients with complete (n=74) and imputed data, all outcomes improved significantly at two years. Over 75
