Purpose Malignancies may cause urinary tract obstruction, which is often relieved with placement of a percutaneous nephrostomy tube, an internal double J nephro-ureteric stent (double J), or an internal external nephroureteral stent (NUS). We evaluated the affect of these palliative interventions on quality of life (QoL) using previously validated surveys. Methods Forty-six patients with malignancy related ureteral obstruction received nephrostomy tubes (n = 16), double J stents (n = 15), or NUS (n = 15) as determined by a multidisciplinary team. QoL surveys were administered at 7, 30, and 90 days after the palliative procedure to evaluate symptoms and physical, social, functional, and emotional well-being. Number of related procedures, fluoroscopy time, and complications were documented. Kruskal–Wallis and Friedman’s test were used to compare patients at 7, 30, and 90 days. Spearman’s rank correlation coefficient was used to assess correlations between clinical outcomes/symptoms and QoL. Results Responses to QoL surveys were not significantly different for patients receiving nephrostomies, double J stents, or NUS at 7, 30, or 90 days. At 30 and 90 days there were significantly higher reported urinary symptoms and pain in those receiving double J stents compared with nephrostomies (P = 0.0035 and P = 0.0189, respectively). Significantly greater fluoroscopy time was needed for double J stent–related procedures (P = 0.0054). Nephrostomy tubes were associated with more frequent minor complications requiring additional changes. Conclusion QoL was not significantly different. However, a greater incidence of pain in those receiving double J stents and more frequent tube changes in those with nephrostomy tubes should be considered when choosing palliative approaches.
Point your SmartPhone at the code above. If you have a QR code reader the video abstract will appear. Or use: https://youtu.be/ZQdL9fUadAEBackground: Tirapazamine (TPZ) is a hypoxia activated drug that may be synergistic with transarterial embolization (TAE). The primary objective was to evaluate the safety of combining TPZ and TAE in patients with unresectable HCC and determine the optimal dose for Phase II. Methods: This was a Phase 1 multicenter, open-label, non-randomized trial with a classic 3 +3 dose escalation and an expansion cohort in patients with unresectable HCC, Child Pugh A, ECOG 0 or 1. Two initial cohorts consisted of I.V. administration of Tirapazamine followed by superselective TAE while the remaining three cohorts underwent intraarterial administration of Tirapazamine with superselective TAE. Safety and tolerability were assessed using NCI CTCAE 4.0 with clinical, imaging and laboratory examinations including pharmacokinetic (PK) analysis and an electrocardiogram 1 day pre-dose, at 1, 2, 4, 6, 10, and 24 hours post-TPZ infusion and an additional PK at 15-and 30-minutes post-TPZ. Tumor responses were evaluated using mRECIST criteria.Results: Twenty-seven patients (mean [range] age of 66.4 [37-79] years) with unresectable HCC were enrolled between July 2015 and January 2018. Two patients were lost to followup. Mean tumor size was 6.53 cm ± 2.60 cm with a median of two lesions per patient. Dose limiting toxicity and maximum tolerated dose were not reached. The maximal TPZ dose was 10 mg/m 2 I.V. and 20 mg/m 2 I.A. One adverse event (AE) was reported in all patients with fatigue, decreased appetite or pain being most common. Grade 3-5 AE were hypertension and transient elevation of AST/ALT in 70.4% of patients. No serious AE were drug related. Sixty percent (95% CI=38.7-78.9) achieved complete response (CR), and 84% (95% CI=63.9-95.5) had complete and partial response per mRECIST for target lesions. Discussion: TAE with TPZ was safe and tolerable with encouraging results justifying pursuit of a Phase II trial.
Background Pseudoaneurysms (PAs) caused by traumatic injury to the arterial vasculature have a high risk of rupture, leading to life-threatening hemorrhage and mortality, requiring urgent treatment. The purpose of this study was to determine the technical and clinical outcomes of endovascular treatment of visceral and extremity traumatic pseudoaneurysms. Methods Clinical data were retrospectively collected from all patients presenting for endovascular treatment of PAs between September 2012 and September 2018 at a single academic level one trauma center. Technical success was defined as successful treatment of the PA with no residual filling on post-embolization angiogram. Clinical success was defined as technical successful treatment with no rebleeding throughout the follow-up period and no reintervention for the PA. Results Thirty-five patients (10F/25M), average age (± stdev) 41.7 ± 20.1 years, presented with PAs secondary to blunt (n = 31) or penetrating (n = 4) trauma. Time from trauma to intervention ranged from 2 h - 75 days (median: 4.4 h, IQR: 3.5–17.1 h) with 27 (77%) of PAs identified and treated within 24 h of trauma. Average hospitalization was 13.78 ± 13.4 days. Ten patients underwent surgery prior to intervention. PA number per patient ranged from 1 to 5 (multiple diffuse). PAs were located on the splenic (n = 12, 34.3%), pelvic (n = 11, 31.4%), hepatic (n = 9, 25.7%), upper extremity/axilla (n = 2, 5.7%), and renal arteries (n = 1, 2.9%). Technical success was 85.7%. Clinical success was 71.4%, for technical failure (n = 5), repeat embolization (n = 1) or post-IR surgical intervention (n = 4). There was no PA rebleeding or reintervention for any patient after discharge over the reported follow-up periods. Three patients died during the trauma hospitalization for reasons unrelated to the PAs. Conclusions Endovascular treatment of traumatic visceral and extremity PAs is efficacious with minimal complication rates and low reintervention requirements.
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