Ospedale San Carlo

Objectives: Focal therapy (FT) is increasingly employed in selected patients with localized prostate cancer (PCa), aiming to balance oncologic control with preservation of urinary and sexual function. Among the available energy sources, prostate gland cryoablation (PGC) and high-intensity focused ultrasound (HIFU) are the most widely adopted techniques. However, comparative outcome data remain limited, and standardized composite endpoints are still lacking in this domain. Methods: We conducted a prospective, single-center study on 163 consecutive patients treated with FT, either HIFU (n = 49) or PGC (n = 114), for clinically localized PCa between 2019 and 2024. The primary aim was to compare baseline, perioperative, oncologic, and functional outcomes at 1-year follow-up. The secondary objective was to identify predictors of trifecta achievement, defined as: (1) absence of treatment failure; (2) urinary continence (no pads or one safety pad/day); and (3) recovery of erectile function comparable to baseline. Results: HIFU was associated with shorter operative time (p = 0.04) but required longer catheterization (p < 0.001). Compared with HIFU, primary whole-gland cryoablation (PGC) showed a higher overall complication rate (p < 0.001), mostly grade I-II events. Median follow-up was shorter for HIFU (12 vs. 23 months, p < 0.001). Further, 1-year treatment failure occurred in 8.1% of HIFU cases and 8.7% of PGC cases (p = 0.96), although failure-free survival was comparable between groups (p = 0.89). Functional outcomes were similar, with no significant differences in continence or potency recovery, and trifecta rates were 38.9% (HIFU) vs. 37.4% (PGC; p = 0.355). On multivariable analysis, hypertension, lower PSA, higher baseline erectile function, and unilateral ablation independently predicted trifecta achievement. Conclusions: In this prospective comparison between HIFU and PGC, we observed similar trifecta achievement rates, with no significant differences in continence or erectile function recovery at 1 year. Although treatment failure was slightly more frequent after HIFU, overall outcomes support the functional safety and oncologic feasibility of both approaches in selected patients. These findings suggest that adopting a standardized composite endpoint may be clinically useful, even if further refinement and validation are still needed to capture the specific goals and nuances of focal therapy.

Despite continuous improvements in neonatal resuscitation and stabilization in the last decades, thermal management immediately after birth remains an unresolved issue in preterm infants. To compare 2 strategies of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants. This multicenter, unblinded, randomized clinical trial was conducted among very preterm infants (birth weight <1500 g and/or gestational age ≤30 weeks 6 days) at 21 tertiary care hospitals in Italy from February 21, 2023, to July 18, 2024. Eligible neonates were randomly allocated to either drying before plastic wrapping in the delivery room (intervention arm) or plastic wrapping without drying (control arm). The primary outcome was the proportion of participants with normothermia (36.5-37.5 °C) at admission to the neonatal intensive care unit (NICU). The secondary outcomes included hypothermia (<36.5 °C), moderate to severe hypothermia (<36.0 °C), and hyperthermia (>37.5 °C) at NICU admission, temperature at 1 hour after NICU admission, intraventricular hemorrhage, respiratory distress syndrome, late-onset sepsis, bronchopulmonary dysplasia, and mortality before hospital discharge. Overall, 354 very preterm infants were randomized (180 [50.8%] female; mean [SD] gestational age, 28.6 [2.5] weeks); all received the allocated intervention and were included in the analysis. Normothermia at NICU admission was achieved in 81 of 177 dried infants (45.8%) and 82 of 177 undried infants (46.3%; risk ratio, 0.99; 95% CI, 0.79-1.24). The mean (SD) neonatal temperature at NICU admission was 36.4 °C (0.8 °C) in dried neonates and 36.5 °C (0.7 °C) in undried neonates (mean difference, -0.1 °C; 95% CI, -0.2 °C to 0.1 °C). In-hospital mortality included 26 of 177 dried neonates (14.7%) and 10 of 177 undried neonates (5.6%) (unadjusted risk ratio, 2.60; 95% CI, 1.29-5.23). The other secondary outcome measures were not different between the 2 arms. In this multicenter randomized clinical trial, drying before plastic wrapping provided no benefit to very preterm infants in maintaining normothermia at NICU admission. Most deaths could be expected due to the compromised profile of the neonates, with no pathophysiological explanation related to the trial interventions. Approximately half of the infants were outside the normal thermal range at NICU admission; hence, thermal management remains a challenge requiring further investigations. ClinicalTrials.gov Identifier: NCT05740072.

In Autoimmunology, interpretative comments can significantly improve the quality of information in laboratory reports. Laboratory autoimmunologists play an increasingly important role in supporting clinicians with the request and interpretation of tests, considering the growing complexity of autoimmune diagnostic and the increase in requests for autoimmune tests by non-specialist physicians. In 2024, the Study Group on Autoimmunology (GdS-AI) of the Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) in collaboration with the Study Group of Extra-Analytical Quality (GdS-QuEA) developed a project with the aim to define interpretative comments for systemic autoimmune diseases and organ-specific autoimmune diseases. Based on the analysis of the comments used by GdS-AI laboratories in routine practice, the working group drafted a summary document including no. 47 interpretative comments (22 for systemic autoimmune diseases and 25 for organ-specific autoimmune diseases), representative of possible findings in autoimmune laboratory reports. The document is intended as a proposal of interpretative comments to support laboratory reporting. Furthermore, it defines the important role of the laboratory autoimmunologist in improving the informational quality of reports, while promoting harmonization and appropriateness of test ordering.

There is a significant need for trials that evaluate the treatment of University of Texas (UT) grade 2 and 3 diabetic foot ulcers (bone, joint, or tendon exposed wounds). We undertook a trial looking at the effect of intact fish skin graft (IFSG) on these deep and difficult-to-heal ulcers. 262 patients Intent to Treat (ITT) patients with UT grade 2 and 3 DFUs were randomised to receive intact fish skin graft (IFSG) or a standardised treatment (SOC) that adhered to the International Working Group on the Diabetic Foot (IWGDF) guidelines. The secondary endpoints that were measured included wound area reduction (WAR), healing rates at 20 and 24 weeks; closure rates by UT grade, perfusion, quality of life, pain reduction and IFSG safety. We report ITT (all randomised) (mITT previosly reported) The (WAR) at 12 weeks was 65.53% for IFSG versus 30.82% for SOC (p = 0.007). UT 2 wounds (60% of total) exhibited a closure rate of 47% versus 23% at 16 weeks for IFSG versus SOC (p = 0.0033). Target wound infections were comparable (39 vs. 37) and major outcomes were comparable during the 24 week period (target-limb amputations 8% vs. 7%). Time-to-heal favoured IFSG (restricted mean to 24 weeks 17.31 vs. 19.37 weeks; KM/log-rank significant; Cox HR 1.59). The in the treatment of deep complex diabetic foot wounds the addition of IFSG significantly improved the number of patients with total wound closure as well as the time to wound closure without increased risk of complications. This improvement in total wound closure and time to wound closure was noted across prior amputation status, quality of perfusion, and UT grade.

Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) relapse is the most frequent cause of allogeneic stem cell transplantation (allo-SCT) failure. The utility of post-relapse therapy is controversial due to the high incidence of toxicity and the low efficacy. This sub-analysis of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO) AML/MDS relapse study focuses on 647 AML/MDS relapsing after allo-SCT performed between 2015 and 2021. Following the relapse, these patients were treated with either hypomethylating agents (HMAs)-based therapy (n = 308) or other treatments (n = 339), including intensive chemotherapy, FLT3-inhibitors, and second allo-SCT. HMAs-based therapies were more frequently used in older patients, transplanted not in CR following a reduced-intensity conditioning regimen. The overall response rate (ORR) with or without HMA-based salvage treatment was 33% and 40%, respectively (P = .006). The complete remission (CR) rate was 23% and 33% in the two groups, respectively (P < .001). The long-term OS and TRM of the two groups were superimposable. Independently from the type of salvage, an advantage in OS was observed when donor lymphocytes infusion (DLI) was included (P < .001). Relapse within 12 months after SCT, low disease burden at relapse, and the CR status at transplant confirmed their independent strong prognostic impact on both HMA and non-HMA-based group (HR 0.05, 0.44, and 0.49 and HR 0.19, 0.32, and 0.53, respectively). Despite the lower ORR observed with HMA-based therapy, the long-term OS was comparable to that observed with other therapies. The immune control of the disease relapse with DLI is of benefit, independently from the salvage therapy. .

To evaluate, in Obstructive sleep apnea (OSA) patients, the use of pre-treatment drug-induced sleep endoscopy (DISE) as a patient selection tool, that could improve the outcomes of mandibular advancement device (MAD) therapy. A multicenter retrospective case-control study has been performed. A multicenter case-control study with two parallel arms was conducted to compare functional outcomes in patients undergoing MAD therapy. Group A (n=118) received MAD therapy based solely on static clinical assessments, including dentoskeletal features, oropharyngeal anatomy, and upper airway endoscopy. Group B (n=87) underwent pre-treatment DISE to dynamically evaluate the site, type, and pattern of upper airway collapse, thereby guiding patient selection for MAD therapy. In Group A, the mean pre-treatment apnea-hypopnea index (AHI) was 28.1, decreasing significantly to 12.4 post-treatment (p=0.0001). In Group B, the mean AHI decreased from 31.3 to 9.5 (p=0.0001). The Delta apnea-hypopnea index (ΔAHI) was significantly greater in Group B (-21.7) than in Group A (-16.6; p=0.04). Similarly, the Delta Oxigen desaturation index (ΔODI) was -18.6 in Group B versus -14.1 in Group A (p=0.04). The therapeutic success rate was significantly higher in Group B (82.7%) compared to Group A (60.1%) (p=0.001). In OSA patients, a pre-treatment DISE evaluation, improves the selection of appropriate candidates for MAD therapy by enabling dynamic assessment of upper airway collapsibility during a pharmacologically induced sleep. This targeted selection results in significantly better therapeutic outcomes for MAD therapy for the OSA treatment.

Background/Objectives: Surgical clipping remains a fundamental treatment modality for intracranial aneurysms, particularly in complex cases and those not amenable to endovascular approaches. However, it is associated with several technical challenges and potential complications that may compromise patient outcomes. This study aims to identify and analyze the most frequent and critical intraoperative pitfalls encountered during microsurgical clipping. We discuss experience-based strategies for avoiding these complications as well as practical solutions for managing them effectively when they occur. Methods: A retrospective review of our institutional experience with surgically treated intracranial aneurysms is reported. The study includes a comprehensive analysis of complications encountered across a defined series of cases, along with representative clinical cases. Results: Several categories of complications were identified, including aneurysm rupture, incomplete clipping and aneurysm remnant, vessel stenosis and brain ischemia, and new-onset seizures. Specific microsurgical techniques, intraoperative tools (e.g., indocyanine-green angiography, neurophysiological monitoring, micro-Doppler flowmetry evaluation), and decision-making algorithms are discussed to help mitigate these risks. For each scenario, tailored rescue strategies are outlined based on both the literature evidence and our clinical experience. Conclusions: Awareness of the potential pitfalls in aneurysm clipping and a structured approach to their prevention and management are crucial for optimizing surgical outcomes, and for preparing young vascular neurosurgeons. Through a combination of technical refinement and scenario-based preparedness, many complications can be anticipated and effectively addressed.

Background: Many literature studies have reported the beneficial effects of probiotics on human health, but few articles have evaluated their “real effects” on the modulation of microbiota after their use. Lactobacillus reuteri (L. reuteri) is one of the most studied probiotics with the best effects on gut microbiota. Aims: The primary aim of our study was the evaluation of the intestinal colonization by L. reuteri-LMG P 27481 and its effects on the modification of the gut bacterial flora. The secondary aim was the evaluation of side effects through the validated Gastrointestinal Symptom Rating Scale (GSRS). Patients and Methods: This is an interventional, open-label study conducted on 20 healthy adults (10 men and 10 women M/F; mean age 34 ±15 years) who received a probiotic Reuterin® LMG (L. reuteri LMG P 27481) for 28 consecutive days in drops at a concentration of 1 × 109 (five drops per day). Microbiota analysis was performed at enrollment (T0), at the end of probiotic supplementation (T1) and after a 14-day follow-up period (T2). Results: In our study we observed interesting quantitative and functional variations as regards the Firmicutes/Bacterioidetes ratio, intestinal permeability, and the production of short-chain fatty acids (SCFA). This probiotic was safe and was able to improve patients’ symptoms. Conclusions: The intake of L. reuteri LMG-P 27481 in healthy subjects showed transitory variations in some functional and metabolic gut functions, especially an improvement in the barrier effect and intestinal permeability, y and an increase in SCFA. Future studies should include target populations to have a greater range for modulation of the gut microbiota.