| 1. |
- de Graaf, Nine, et al.
(author)
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Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2) : study protocol for an international multicenter patient-blinded randomized controlled trial
- 2023
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In: Trials. - : BioMed Central Ltd. - 1745-6215. ; 24:1
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Journal article (peer-reviewed)abstract
- Background: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration: ISRCTN27483786. Registered on August 2, 2023. © 2023, BioMed Central Ltd., part of Springer Nature.
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| 2. |
- Gentiluomo, Manuel, et al.
(author)
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Mitochondrial DNA Copy-Number Variation and Pancreatic Cancer Risk in the Prospective EPIC Cohort
- 2020
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In: Cancer Epidemiology, Biomarkers and Prevention. - Philadelphia : American Association for Cancer Research. - 1055-9965 .- 1538-7755. ; 29:3, s. 681-686
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Journal article (peer-reviewed)abstract
- Background: Mitochondrial DNA (mtDNA) copy number in peripheral blood has been found to be sociated with risk of developing several cancers. However, data on pancreatic ductal adenocarcinoma DAC) are very limited.Methods: To further our knowledge on this topic, we measured relative mtDNA copy number by a antitative real-time PCR assay in peripheral leukocyte samples of 476PDACcases and 357 controls sted within the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort.Results: We observed lower mtDNA copy number with advancing age (P = 6.54 x 10(-5)) and with a high dy mass index (BMI) level (P = 0.004) and no association with sex, smoking behavior, and alcohol nsumption. We found an association between increased mtDNA copy number and decreased risk of veloping PDAC with an odds ratios (OR) of 0.35 [95% confidence interval (CI), 0.160.79; P = 0.01] when mparing the fifth quintile with the first using an unconditional logistic regression and an OR of 0.19 5% CI, 0.07-0.52; P = 0.001) with a conditional analysis. Analyses stratified by BMI showed an sociation between high mtDNA copy number and decreased risk in the stratum of normal weight, nsistent with the main analyses.Conclusions: Our results suggest a protective effect of a higher number of mitochondria, measured in ripheral blood leukocytes, on PDAC risk.Impact: Our findings highlight the importance of understanding the mitochondrial biology in pancreatic ncer.
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| 3. |
- Testa, Veronica, et al.
(author)
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Micromechanical behaviour and wear resistance of hybrid plasma-sprayed TiC reinforced Tribaloy-400
- 2021
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In: Surface & Coatings Technology. - : Elsevier. - 0257-8972 .- 1879-3347. ; 425
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Journal article (peer-reviewed)abstract
- Cobalt-based alloys such as Tribaloy-400 are known for their sliding wear resistance at room as well as elevated temperature. However, further enhancement in terms of hardness and wear resistance could be achieved by creating metal matrix composites reinforced by ceramic particles. For this purpose, Tribaloy-400 based coatings were deposited with the addition of different amounts of TiC reinforcement (≈25 vol%, ≈40 vol%, ≈60 vol%) through a “hybrid” plasma spray process, using a dry Tribaloy-400 powder with 10–45 μm particle size and a water-based TiC suspension (d50 = 2.2 μm). Pure Tribaloy and pure TiC coatings were employed for comparison. During spraying, TiC was partly oxidized but could nonetheless be embedded between the bigger Tribaloy-400 lamellae. Specifically, the coating containing ≈ 25 vol% TiC shows a homogeneous microstructure, whilst greater amounts of hard phase lead to some agglomeration. Accordingly, the coating with 25 vol% TiC exhibits a good combination of hardness and toughness (the latter being assessed by scratch testing) and low sliding wear rates of ≈10−5–10−6 mm3/(N·m) from room temperature up to 700 °C in ball-on-disc tests against an Al2O3 counterbody. At room temperature, the tribological behaviour of the coatings is controlled by abrasive grooving and spallation due to surface fatigue. With increasing temperature, tribochemical phenomena take on an ever-increasing role and, at 700 °C, a uniform, oxide-based tribofilm is developed, so that the wear rates are often lower than are recorded at 400 °C.
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| 4. |
- Torkashvand, Kaveh, 1990-, et al.
(author)
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Tribological behavior of HVAF-sprayed WC-based coatings with alternative binders
- 2022
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In: Surface & Coatings Technology. - : Elsevier. - 0257-8972 .- 1879-3347. ; 436
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Journal article (peer-reviewed)abstract
- The tribological performance of High Velocity Air-Fuel (HVAF) sprayed WC-based cermet coatings with binders containing no or very limited amount of cobalt was evaluated under dry sliding, erosion, and abrasion wear conditions. The wear and corrosion behaviors of WC-NiMoCrFeCo, WC-FeNiCrMoCu and WC-FeCrAl HVAF sprayed coatings were investigated and compared to standard WC-CoCr coatings as benchmark. Microstructure characterization along with XRD analysis was conducted on all powders as well as the corresponding coatings. Comprehensive post wear analysis was conducted on all coatings subjected to ball-on-disk, gas jet erosion and dry sand-rubber wheel abrasion tests. Moreover, all coatings were exposed to 3.5% (wt./vol.) NaCl aqueous solution to evaluate their corrosion performance through electrochemical testing. XRD results showed negligible phase transformation between the powders and the deposited coatings. The WC-NiMoCrFeCo coating exhibited the best sliding wear and electrochemical corrosion performance, with an average specific wear rate value of 3.1 x 10(-8) (mm(3).N-1.m(-1)) and a corrosion current density of 1.9 mu A/cm2. This coating also showed comparable abrasive wear resistance to the WC-CoCr coating. Under erosive wear conditions, too, the WC-FeNiCrMoCu and WC-FeCrAl coatings showed a comparable performance to the benchmark. Dominant wear mechanisms for the reference WC-CoCr coating, under sliding wear conditions, were abrasion (deep grooving) and surface fatigue (crack propagation and pitting). On the contrary, no pitting was observed in WC-NiMoCrFeCo and WC-FeCrAl coatings during the sliding wear test. No considerable difference was identified in the wear mechanisms of the different coatings under abrasion and erosion wear conditions. The results highlight the promise of some of the environment friendly binders studied to replace Co.
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