11 research outputs found

    Colorectal liver metastases: Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial

    Get PDF
    Background: Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. Methods: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). Discussion: If thermal ablation proves to be non-inferior in treating lesions ≤3cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM. Trial registration:NCT03088150 , January 11th 2017

    Preparation and gas sensing properties of nanocomposite polymers on micro-Interdigitated electrodes for detection of volatile organic compounds at room temperature

    No full text
    A room-temperature chemocapacitive gas sensor based on polymeric nanocomposites (NCs) consisting of amine-terminated silicon nanoparticles (Si NPs-NH2) and poly (4-vinylphenol) was fabricated on a micro-gap interdigitated electrode (M-IDE), and used for the detection of acetone. Several polymers were explored to capture acetone, of which poly (4-vinylphenol) showed best results. The response of the sensor was significantly improved by the addition of silicon nanoparticles to the polymer layer. The response characteristics of the NC film towards volatile organic compounds (VOCs) were determined and compared with the pristine polymeric layer in this study. It was shown that the polymeric NC layer can detect acetone at room temperature within one minute. The sensing response towards acetone at room temperature proved that the turn–on and −off exposure to this analyte was reversible with good reproducibility (5% decay) after multiple cycles of gas exposure. The proof-of-concept results are promising for the development of novel gas detectors that are applicable in many fields such as industrial and laboratorial security.</p

    Preparation and gas sensing properties of nanocomposite polymers on micro-Interdigitated electrodes for detection of volatile organic compounds at room temperature

    No full text
    A room-temperature chemocapacitive gas sensor based on polymeric nanocomposites (NCs) consisting of amine-terminated silicon nanoparticles (Si NPs-NH2) and poly (4-vinylphenol) was fabricated on a micro-gap interdigitated electrode (M-IDE), and used for the detection of acetone. Several polymers were explored to capture acetone, of which poly (4-vinylphenol) showed best results. The response of the sensor was significantly improved by the addition of silicon nanoparticles to the polymer layer. The response characteristics of the NC film towards volatile organic compounds (VOCs) were determined and compared with the pristine polymeric layer in this study. It was shown that the polymeric NC layer can detect acetone at room temperature within one minute. The sensing response towards acetone at room temperature proved that the turn–on and −off exposure to this analyte was reversible with good reproducibility (5% decay) after multiple cycles of gas exposure. The proof-of-concept results are promising for the development of novel gas detectors that are applicable in many fields such as industrial and laboratorial security.</p

    A longitudinal study using tibial ultrasonometry as a bone assessment technique in children with acute lymphoblastic leukaemia

    No full text
    BACKGROUND: Several longitudinal studies have shown contradictory results regarding the change in bone status in children with acute lymphoblastic leukaemia (ALL) using dual-energy X-ray absorptiometry as the bone assessment technique. OBJECTIVE: To determine whether a more recently developed bone assessment technique which does not use radiation, tibial ultrasonometry, can be used for the detection of short-term changes. PATIENTS AND METHODS: From January 1997 to February 2001, 37 patients (25 boys, 12 girls, mean age 9.0 years, range 3.0-16.8 years) were included in a longitudinal study to assess changes in bone status induced by the disease itself and/or treatment. Of these 37 patients, 35 had a measurement at the start of therapy (t0), 26 at 6 months (t6), 24 at 12 months (t12), 11 at 24 months (t24) and 9 at 36 months (t36). For assessment of bone mass, the tibial ultrasound (US) device SoundScan Compact was used, which measures the speed of sound (SOS) along the cortex of the tibia over a fixed length of 5 cm at the mid-tibial point. RESULTS. The SOS standard deviation (SD) scores were significantly lower at t6, t12, t24 and t36 than at baseline (t0). The biggest change was found between t0 and t6. During follow-up, no significant correlation was found between changes from baseline of height SD scores and SOS SD scores, indicating that tibial ultrasonometry was not measuring growth. After ending therapy (t36), no further growth retardation was found. CONCLUSIONS: Short-term changes of SOS SD scores in children with ALL can be detected by tibial ultrasonometry. Tibial ultrasonometry measures a change in bone status, not growth

    Routine Postsurgical Anesthesia Visit to Improve 30-day Morbidity and Mortality: A Multicenter, Stepped-wedge Cluster Randomized Interventional Study (The TRACE Study)

    No full text
    Objective: To study the impact of a standardized postoperative anesthesia visit on 30-day mortality in medium to high-risk elective surgical patients. Background: Postoperative complications are the leading cause of perioperative morbidity and mortality. Although modified early warning scores (MEWS) were instituted to monitor vital functions and improve postoperative outcome, we hypothesized that complementary anesthesia expertise is needed to adequately identify early deterioration. Methods: In a prospective, multicenter, stepped-wedge cluster randomized interventional study in 9 academic and nonacademic hospitals in the Netherlands, we studied the impact of adding standardized postoperative anesthesia visits on day 1 and 3 to routine use of MEWS in 5473 patients undergoing elective noncardiac surgery. Primary outcome was 30-day mortality. Secondary outcomes included: incidence of postoperative complications, length of hospital stay, and intensive care unit admission. Results: Patients were enrolled between October 2016 and August 2018. Informed consent was obtained from 5473 patients of which 5190 were eligible for statistical analyses, 2490 in the control and 2700 in the intervention group. Thirty-day mortality was 0.56% (n = 14) in the control and 0.44% (n = 12) in the intervention group (odds ratio 0.74, 95% Confidence interval 0.34-1.62). Incidence of postoperative complications did not differ between groups except for renal complications which was higher in the control group (1.7% (n = 41) vs 1.0% (n = 27), P = 0.014). Median length of hospital stay did not differ significantly between groups. During the postanesthesia visits, for 16% (n = 437) and 11% (n = 293) of patients recommendations were given on day 1 and 3, respectively, of which 67% (n = 293) and 69% (n = 202) were followed up. Conclusions: The combination of MEWS and a postoperative anesthesia visit did not reduce 30-day mortality. Whether a postoperative anesthesia visit with strong adherence to the recommendations provided and in a high-risk population might have a stronger impact on postoperative mortality remains to be determined. Trial Registration: Netherlands Trial Registration, NTR5506/ NL5249, https://www.trialregister.nl/trial/5249
    corecore