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HPLC-MS/MS method for simultaneous analysis of plasma 2-hydroxybuty-rate and 2-hydroxyisobutyrate: Development and clinical significance

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CLINICA CHIMICA ACTA 2025年 565卷 120023页

作者： campi, beatrice Vitelli, Valentina Saponaro, Federica Zucchi, Riccardo Ferrannini, Ele Saba, Alessandro CNR Inst Clin Physiol Via Giuseppe Moruzzi 1 I-56124 Pisa Italy Univ Pisa Dept Surg Med & Mol Pathol & Crit Care Med Via Savi 10 I-56126 Pisa Italy Univ Pisa Ctr Instrument Sharing Lungarno Pacinotti 43-44 I-56126 Pisa Italy

Recent studies have identified relationships between diabetes mellitus and short-chain fatty acids, including 2hydroxybutyrate (2-HB) and 2-hydroxyisobutyrate (2-HiB);2-HB has been associated to the early stages of insulin resistance, while 2-HiB with the risk and progression of complications of Type 1 diabetes. Their metabolism and pathophysiological role in humans are not fully clarified. The possible association between 2-HB and 2-HiB and diabetes mellitus was investigated with a novel mass spectrometry-based assay, capable of discriminating plasma 2-HiB and 2-HB from their HB isomers. Accuracy and precision (RSD%) were always in the range 99-102% and 0.7-3.5%, respectively. The study involved samples from subjects with normal glucose tolerance (NGT) and Type 2 diabetes (T2D), originally included in a multicenter study investigating mechanisms involved in atherothrombosis. NGT subjects exhibited concentrations of 2-HB and 2-HiB of 61 (36) and 3.1 (1.9) mu mol/L, median (interquartile range), respectively, that were significantly lower than those of the T2D patients, whose values were 74 (4.0) and 3.8 (2.9) mu mol/L, respectively. The pattern of association of these molecules with clinical and metabolic variables is partially different: both compounds were directly related to male sex, BMI, HbA1c, and plasma glucose, 2-HiB also with age, systolic blood pressure, and HDL-cholesterol. Furthermore, they correlate with free fatty acids, glycerol, and triglyceride concentrations, but the latter correlation was negative for 2-HB and positive for 2-HiB. Results confirmed the clinical significance of 2-HB and 2-HiB, in differential association with metabolic features of T2D.

关键词： 2-hydroxybutyrate 2-hydroxyisobutyrate HPLC Mass spectrometry

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Quantification of D-mannose in plasma: Development and validation of a reliable and accurate HPLC-MS-MS method

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CLINICA CHIMICA ACTA 2019年 493卷 31-35页

作者： campi, beatrice Codini, Simone Bisoli, Niccolo Baldi, Simona Zucchi, Riccardo Ferrannini, Ele Saba, Alessandro CNR Inst Clin Physiol Pisa Italy Univ Pisa Dept Clin & Expt Med Pisa Italy Univ Pisa Dept Surg Med & Mol Pathol & Crit Care Med Pisa Italy St Chiara Univ Hosp Lab Clin Pathol Pisa Italy

The present paper describes the development and the validation process in compliance with the EMA guidelines of a method based on tandem mass spectrometry coupled to liquid chromatography for the accurate quantification of mannose in human plasma samples. The quick sample preparation procedure, simplified by the absence of any derivatization step, makes the assay suitable for routine use in a clinical chemistry laboratory. The method validation yielded satisfactory selectivity, with a good separation of mannose from its epimers (glucose and galactose), linearity over the whole concentration range of interest (0.31-40 mu g/mL), reproducibility with RSD < 10%, and accuracy in the range 96-104%. Instrumental LLOD (0.31 mu g/mL) and LLOQ (1.25 mu g/mL) were good enough to detect endogenous plasma mannose levels and in agreement with recent data from the literature. Sensitivity was affected by a 5-fold dilution factor, which, if necessary, can be reduced. The method robustness was proven in > 600 injections, most of them being of plasma samples, used also to assess the reference ranges in healthy subjects (9.93 +/- 3.37 mu g/mL) and type 2 diabetic patients (23.47 +/- 6.19 mu g/mL).

关键词： D-mannose Tandem mass spectrometry HPLC Validation

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Quantification of dehydroepiandrosterone in human serum on a routine basis: development and validation of a tandem mass spectrometry method based on a surrogate analyte

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ANALYTICAL AND BIOANALYTICAL CHEMISTRY 2018年第2期410卷 407-416页

作者： campi, beatrice Frascarelli, Sabina Pietri, Elisabetta Massa, Ilaria Donati, Caterina Bozic, Roberto Bertelloni, Silvano Paolicchi, Aldo Zucchi, Riccardo Saba, Alessandro Univ Pisa Dept Translat Res & New Surg & Med Technol Via Savi 10 I-56126 Pisa Italy Univ Pisa Dept Surg Med & Mol Pathol & Crit Care Med Via Savi 10 I-56126 Pisa Italy Ist Sci Romagnolo Studio & Cura Tumori IRST IRCCS Dept Med Oncol Via Piero Maroncelli 40 I-47014 Meldola Forli Cesena Italy Ist Sci Romagnolo Studio & Cura Tumori IRST IRCCS Unit Biostat & Clin Trials Via Piero Maroncelli 40 I-47014 Meldola Forli Cesena Italy Ist Sci Romagnolo Studio & Cura Tumori IRST IRCCS Oncol Pharm Lab Via Piero Maroncelli 40 I-47014 Meldola Forli Cesena Italy Perkin Elmer Italia SpA Viale Innovaz 3 I-20125 Milan Italy St Chiara Univ Hosp Div Pediat Dept Obstet Gynecol & Pediat Via Roma 67 I-56126 Pisa Italy St Chiara Univ Hosp Dept Lab Med Clin Pathol Lab Via Roma 67 I-56126 Pisa Italy

In the clinical laboratories, dehydroepiandrostenedione (DHEA) is usually quantified by immunoassay-based methods, which are often affected by cross-reactivity with endogenous interferences, such as 4-androsten-3 beta-ol-17-one. The interfering compounds lead to a poor accuracy of the measurements, mainly at a low concentration level. The present paper describes a validated method based on tandem mass spectrometry coupled to liquid chromatography, for the accurate quantification of DHEA in serum. The peculiarity of this method is the use of calibrators and quality controls prepared by adding measured amounts of DHEA-D-5, a stable isotope-labeled analogue of DHEA, to real serum from healthy subjects. DHEA-D-5 is used in place of DHEA, which is usually present in unstripped serum at physiological levels, as it has the same basic structure, provides an equivalent instrumental response, and can be easily distinguish by DHEA by mass spectrometry due to its different m/z value. The method proved to be sensitive, with a LLOD of 0.09 ng/mL and a LLOQ of 0.23 ng/mL, and selective, with overall performances that allow its use on a routine basis.

关键词： DHEA DHEA-D-5 Laboratory medicine Liquid chromatography Tandem mass spectrometry

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Plasma N-acetylaspartate: Development and validation of a quantitative assay based on HPLC-MS-MS and sample derivatization

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CLINICA CHIMICA ACTA 2020年 508卷 146-153页

作者： campi, beatrice Codini, Simone Daniele, Giuseppe Marvelli, Antonella Ceccarini, Giovanni Santini, Ferruccio Zucchi, Riccardo Ferrannini, Ele Saba, Alessandro CNR Inst Clin Physiol Pisa Italy Univ Pisa Dept Clin & Expt Med Pisa Italy Univ Pisa Dept Surg Med & Mol Pathol & Crit Care Med Pisa Italy St Chiara Univ Hosp Lab Clin Pathol Pisa Italy

N-acetylaspartate is a human endogenous compound synthesized by neurons, which is involved in neuronal metabolism. It is used as a marker in brain magnetic resonance spectroscopy to investigate several neurological and metabolic disorders, that can be related to a variation of its concentration with respect to reference values. N-acetylaspartate is present also in biological fluids, such as plasma, urine, and cerebrospinal fluid, where it can be quantified. Here we describe the development and validation, in compliance with the EMA guidelines, of a novel assay method for the quantification of N-acetylaspartate in plasma based on tandem mass spectrometry coupled to liquid chromatography. Its peculiarity lies in the fact that sample preparation includes an esterification step, which significantly improves the chromatographic performances and, consequently, also the method sensitivity, reproducibility and accuracy. Instrumental LLOQ is 0.06 ng/mL, i.e. at least 300 times lower than the medium N-acetylaspartate concentration in samples, accuracy is in the range 98-103%, while precision lies between 1 and 3%. The method robustness was tested in about 1000 injections of plasma samples, 96 of which were used also to assess the reference ranges in control subjects (16.46-63.40 ng/mL). Controls were then compared to plasma samples from type 2 diabetic patients. Contrary to brain magnetic resonance spectroscopy, which demonstrated a decrease in the N-acetylaspartate levels in right frontal and parieto-temporal region of type 2 diabetic patients, plasma analysis showed no statistical difference with respect to controls. However, the method here described can be profitably used in studies concerning different disorders with CNS involvement, as confirmed by reports available in the literature.

关键词： N-acetylaspartate Plasma Derivatization Tandem mass spectrometry Quantification Validation

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Sweat chloride assay by inductively coupled plasma mass spectrometry: a confirmation test for cystic fibrosis diagnosis

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ANALYTICAL AND BIOANALYTICAL CHEMISTRY 2020年第25期412卷 6909-6916页

作者： Marvelli, Antonella campi, beatrice Mergni, Gianfranco Di Cicco, Maria Elisa Turini, Paola Scardina, Paolo Zucchi, Riccardo Pifferi, Massimo Taccetti, Giovanni Paolicchi, Aldo la Marca, Giancarlo Saba, Alessandro Univ Pisa Dept Surg Med & Mol Pathol & Crit Care Med Pisa Italy CNR Inst Clin Physiol Pisa Italy Meyer Childrens Univ Hosp Cyst Fibrosis Lab Florence Italy St Chiara Univ Hosp Dept Obstet Gynecol & Pediat Pediat Div Pisa Italy St Chiara Univ Hosp Dept Lab Med Lab Clin Pathol Pisa Italy Agilent Technol Italia SpA Milan Italy Univ Pisa Dept Translat Res & New Surg & Med Technol Pisa Italy Univ Florence Dept Expt & Clin Biomed Sci Florence Italy Meyer Childrens Hosp Newborn Screening Clin Chem & Pharmacol Lab Florence Italy

The current guidelines for sweat chloride analysis identify the procedures for sweat collection, but not for chloride assay, which is usually performed by methods originally not aiming at the low concentrations of chloride found in sweat. To overcome this limitation, we set up, characterized, and adopted an original inductively coupled plasma mass spectrometry (ICP-MS) method for sweat chloride determination, which was designed for its easy use in a clinical laboratory. The method was linear in the range 8.5E-3 to 272.0E-3 mM, precision exhibited a relative standard deviation < 6%, and accuracy was in the range 99.7-103.8%. Limit of blank, limit of detection, and limit of quantitation were 2.1 mM, 3.2 mM, and 7.0 mM, respectively, which correspond to real concentrations injected into the mass spectrometer of 3.9E-3 mM for LOD and 8.5E-3 mM for LOQ. At first, the method was tested on 50 healthy volunteers who exhibited a mean chloride concentration of 15.7 mM (25-75th percentile 10.1-19.3 mM, range 2.8-37.4 mM);then, it was used to investigate two patients with suspected cystic fibrosis, who exhibited sweat chloride values of 65.6 mM and 81.2 mM, respectively. Moreover, the method was cross-validated by assaying 50 samples with chloride concentration values in the range 10-131 mM, by both ICP-MS and coulometric titration, which is the technology officially used in Tuscany for cystic fibrosis newborn screening. The reference analytical performances and the relatively low cost of ICP-MS, accompanied by the advantageous cost of a single sweat chloride assay, make this technology the best candidate to provide a top reference method for the quantification of chloride in sweat. The method that we propose was optimized and validated for sweat samples >= 75 mg, which is the minimum amount requested by the international protocols. However, the method sensitivity and, in addition, the possibility to reduce the sample dilution factor, make possible the quantification of chlorid

关键词： Cystic fibrosis Inductively coupled plasma Mass spectrometry Chloride assay

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Mannose as a biomarker of coronary artery disease: Angiographic evidence and clinical significance

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INTERNATIONAL JOURNAL OF CARDIOLOGY 2022年 346卷 86-92页

作者： Ferrannini, Ele Marx, Nikolaus Andreini, Daniele campi, beatrice Saba, Alessandro Gorini, Marco Ferrannini, Giulia Milzi, Andrea Magnoni, Marco Maseri, Attilio Maggioni, Aldo P. Burgmaier, Mathias CNR Inst Clin Physiol Via Savi 10 I-56126 Pisa Italy Univ Hosp RWTH Aachen Germany IRCCS Ctr Cardiol Monzino Milan Italy Univ Milan Dept Clin Sci & Community Hlth Cardiovasc Sect Milan Italy Univ Pisa Lab Biochem Dept Surg Med Mol & Crit Area Pathol Pisa Italy Heart Care Fdn ANMCO Res Ctr Florence Italy Karolinska Inst Dept Med Solna Stockholm Sweden IRCCS Osped San Raffaele Milan Italy Univ Vita Salute San Raffaele Milan Italy

Background: High mannose has previously associated with insulin resistance and cardiovascular disease (CVD). Our objective is to establish whether mannose is associated with anatomical evidence of coronary artery disease (CAD). Methods: Plasma mannose concentrations were measured by liquid chromatography/tandem mass spectrometry in a discovery cohort (n = 513) and a validation cohort (n = 221) of carefully phenotyped individuals. In both cohorts CAD was quantitated using state-of-the-art imaging techniques (coronary computed coronary tomography angiography (CCTA), invasive coronary angiography and optical coherence tomography). Information on subsequent CVD events/death was collected. Associations of mannose with angiographic variables and biomarkers were tested using univariate and multivariate regression models. Survival analysis was performed using the Kaplan-Meier estimator. Results: Mannose was related to indices of CAD and features of plaque vulnerability. In the discovery cohort, mannose was a marker of quantity and quality of CCTA-proven CAD and subjects with a mannose level in the top quartile had a significantly higher risk of CVD events/death (p = 3.6e-5). In the validation cohort, mannose was significantly associated with fibrous cap thickness < 65 mu m (odds ratio = 1.32 per each 10 mu mol/L mannose change [95% confidence interval, 1.05-1.65]) and was an independent predictor of death (hazard ratio for mannose >= vs < 84.6 mu mol/L: 4.0(95%CI, 1.4-11.3), p = 0.006). Conclusion: The current data add novel evidence that high mannose is a signature of CAD with a vulnerable plaque phenotype, consistently across measures of severity of vessel involvement and independent of the traditional correlates of CVD, and that it is an independent predictor of incident adverse outcomes.

关键词： Plasma mannose Coronary atherosclerosis Computed coronary tomography angiography Coronary angiography Optical coherence tomography Risk assessment

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Clinical, pharmacodynamic and pharmacokinetic results of a prospective phase II study on oral metronomic vinorelbine and dexamethasone in castration-resistant prostate cancer patients

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INVESTIGATIONAL NEW DRUGS 2016年第6期34卷 760-770页

作者： Di Desidero, Teresa Derosa, Lisa Galli, Luca Orlandi, Paola Fontana, Andrea Fioravanti, Anna Marconcini, Riccardo Giorgi, Mario campi, beatrice Saba, Alessandro Lucchesi, Sara Felipetto, Renato Danesi, Romano Francia, Giulio Allegrini, Giacomo Falcone, Alfredo Bocci, Guido Univ Pisa Div Pharmacol Dept Clin & Expt Med Via Roma 55 I-56126 Pisa Italy Univ Hosp Pisa Oncol Unit 2 Pisa Italy Univ Pisa Dept Vet Sci Pisa Italy Univ Pisa Dept Surg Med Mol Pathol & Crit Area Pisa Italy Civil Hosp Pontedera Azienda USL Toscana Nord Ovest Oncol Unit Pisa Italy Civil Hosp Pontedera Azienda USL Toscana Nord Ovest Urol Unit Pisa Italy Univ Texas El Paso Border Biomed Res Ctr El Paso TX 79968 USA Univ Pisa Dept Translat Res & New Technol Med & Surg Pisa Italy

The aim of the present study was to evaluate clinical activity, and the pharmacodynamic and pharmacokinetic profiles, of oral metronomic vinorelbine (VNR) plus dexamethasone (DEX) in metastatic castration-resistant prostate cancer (mCRPC) patients. Fourty-one patients (92 % chemotherapy-resistant) received 30 mg/day VNR p.o. thrice a week plus 1 mg/day DEX p.o. until disease progression. Plasma soluble B cell antigen 7 homolog 3 (sB7-H3), vascular endothelial growth factor (VEGF), and thrombospondin-1 (TSP-1), were measured by ELISA. Plasma VNR was detected using a LC-MS-MS system. The fraction of patients free of progression, defined by criteria of the Prostate Cancer Clinical Trials Working Group 2, at 3 months was 61 %. PSA decrease aeyen50 % from baseline was observed in 35 % of patients. Median PFS and OS were 4 months (95 % CI, 2.8-6.9) and 17.5 months (95 % CI, 10.8-24.5), respectively. Toxicity was mild, and no grade 4 toxicities were found. The mean plasma VNR C-max ranged from 1 to 2.7 ng/ml (T-max 1.1 h) and no evidence of drug accumulation was found. A moderate relationship was found between plasma sB7-H3 and PSA values (r = 0.565;P = 0.0094) at the baseline. Increased PFS (11.3 vs. 2.8 months;P = 0.0298) was observed in patients with sB7-H3 levels < 30.25 ng/mL. Plasma VEGF AUC(0-24day) increased in non-responders (P < 0.0001), whereas responders maintained higher plasma TSP-1 AUC(0-24day) (P = 0.0063). In conclusion, metronomic VNR plus DEX showed favourable activity, and a low toxicity profile, in mCRPC patients. Plasma sB7-H3, VEGF and TSP-1 levels are potential pharmacodynamic markers at the reached low plasma concentrations of vinorelbine metronomically administered.

关键词： Prostate cancer Metronomic chemotherapy Vinorelbine Pharmacodynamic markers Pharmacokinetics B7-H3 VEGF TSP-1

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Increase in endogenous glucose production with SGLT2 inhibition is attenuated in individuals who underwent kidney transplantation and bilateral native nephrectomy

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DIABETOLOGIA 2020年第11期63卷 2423-2433页

作者： Daniele, Giuseppe Solis-Herrera, Carolina Dardano, Angela Mari, Andrea Tura, Andrea Giusti, Laura Kurumthodathu, Jancy J. campi, beatrice Saba, Alessandro Bianchi, Anna Maria Tregnaghi, Carla Egidi, Maria Francesca Abdul-Ghani, Muhammad DeFronzo, Ralph Del Prato, Stefano Univ Pisa Dept Clin & Expt Med Sect Metab Dis & Diabet Via Paradisa 2 I-56124 Pisa Italy Univ Texas Hlth Sci Ctr San Antonio Div Diabet San Antonio TX 78229 USA CNR Metab Unit Inst Neurosci Padua Italy

Aims/hypothesis The glucosuria induced by sodium-glucose cotransporter 2 (SGLT2) inhibition stimulates endogenous (hepatic) glucose production (EGP), blunting the decline in HbA(1c). We hypothesised that, in response to glucosuria, a renal signal is generated and stimulates EGP. To examine the effect of acute administration of SGLT2 inhibitors on EGP, we studied non-diabetic individuals who had undergone renal transplant with and without removal of native kidneys. Methods This was a parallel, randomised, double-blind, placebo-controlled, single-centre study, designed to evaluate the effect of a single dose of dapagliflozin or placebo on EGP determined by stable-tracer technique. We recruited non-diabetic individuals who were 30-65 years old, with a BMI of 25-35 kg/m(2)and stable body weight (+/- 2 kg) over the preceding 3 months, and HbA(1c)<42 mmol/mol (6.0%). Participants had undergone renal transplant with and without removal of native kidneys and were on a stable dose of immunosuppressive medications. Participants received a single dose of dapagliflozin 10 mg or placebo on two separate days, at a 5- to 14-day interval, according to randomisation performed by our hospital pharmacy, which provided dapagliflozin and matching placebo, packaged in bulk bottles that were sequentially numbered. Both participants and investigators were blinded to group assignment. Results Twenty non-diabetic renal transplant patients (ten with residual native kidneys, ten with bilateral nephrectomy) participated in the study. Dapagliflozin induced greater glucosuria in individuals with residual native kidneys vs nephrectomised individuals (8.6 +/- 1.1 vs 5.5 +/- 0.5 g/6 h;p = 0.02;data not shown). During the 6 h study period, plasma glucose decreased only slightly and similarly in both groups, with no difference compared with placebo (data not shown). Following administration of placebo, there was a progressive time-related decline in EGP that was similar in both nephrectomised individu

关键词： Dapagliflozin Endogenous glucose production Glucosuria

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Phase II Study of Dehydroepiandrosterone in Androgen Receptor-Positive Metastatic Breast Cancer

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ONCOLOGIST 2019年第6期24卷 743-E205页

作者： Pietri, Elisabetta Massa, Ilaria Bravaccini, Sara Ravaioli, Sara Tumedei, Maria Maddalena Petracci, Elisabetta Donati, Caterina Schirone, Alessio Piacentini, Federico Gianni, Lorenzo Nicolini, Mario Campadelli, Enrico Gennari, Alessandra Saba, Alessandro campi, beatrice Valmorri, Linda Andreis, Daniele Fabbri, Francesco Amadori, Dino Rocca, Andrea IRCCS Ist Sci Romagnolo Studio & Cura Tumori IRST Dept Med Oncol Via Maroncelli 40 I-47014 Meldola Italy IRCCS Ist Sci Romagnolo Studio & Cura Tumori IRST Unit Biostat & Clin Trials Meldola Italy IRCCS Ist Sci Romagnolo Studio & Cura Tumori IRST Biosci Lab Meldola Italy IRCCS Ist Sci Romagnolo Studio & Cura Tumori IRST Oncol Pharm Unit Meldola Italy Univ Hosp Modena Dept Med & Surg Sci Children & Adults Div Med Oncol Modena Italy Infermi Hosp Dept Oncol Rimini Italy Cervesi Hosp Oncol Day Hosp Unit Cattolica Italy Faenza Hosp Oncol Unit Faenza Italy Univ Piemonte Orientale Dept Translat Med Med Oncol Novara Italy Univ Pisa Dept Surg Med & Mol Pathol & Crit Care Med Pisa Italy

Lessons Learned The androgen receptor (AR) is present in most breast cancers (BC), but its exploitation as a therapeutic target has been limited. This study explored the activity of dehydroepiandrosterone (DHEA), a precursor being transformed into androgens within BC cells, in combination with an aromatase inhibitor (to block DHEA conversion into estrogens), in a two-stage phase II study in patients with AR-positive/estrogen receptor-positive/human epidermal growth receptor 2-negative metastatic BC. Although well tolerated, only 1 of 12 patients obtained a prolonged clinical benefit, and the study was closed after its first stage for poor activity. Background Androgen receptors (AR) are expressed in most breast cancers, and AR-agonists have some activity in these neoplasms. We investigated the safety and activity of the androgen precursor dehydroepiandrosterone (DHEA) in combination with an aromatase inhibitor (AI) in patients with AR-positive metastatic breast cancer (MBC). Methods A two-stage phase II study was conducted in two patient cohorts, one with estrogen receptor (ER)-positive (resistant to AIs) and the other with triple-negative MBC. DHEA 100 mg/day was administered orally. The combination with an AI aimed to prevent the conversion of DHEA into estrogens. The main endpoint was the clinical benefit rate. The triple-negative cohort was closed early. Results Twelve patients with ER-positive MBC were enrolled. DHEA-related adverse events, reported in four patients, included grade 2 fatigue, erythema, and transaminitis, and grade 1 drowsiness and musculoskeletal pain. Clinical benefit was observed in one patient with ER-positive disease whose tumor had AR gene amplification. There was wide inter- and intra-patient variation in serum levels of DHEA and its metabolites. Conclusion DHEA showed excellent safety but poor activity in MBC. Although dose and patient selection could be improved, high serum level variability may hamper further DHEA development in this s

关键词： Androgens Androgen Receptor Metastatic Malignant Neoplasm to the Breast Breast Cancer PHASE STUDIES

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Transperineal laser ablation in the management of benign prostatic hyperplasia: an updated systematic review and pooled analysis

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PROSTATE CANCER AND PROSTATIC DISEASES 2025年 1-17页

作者： Alberti, Andrea Lo Re, Mattia Nicoletti, Rossella Polverino, Paolo Cadenar, Anna Ciaralli, Elena Solazzi, Francesca Giustozzi, beatrice Sessa, Francesco Rivetti, Anna campi, Riccardo Sebastianelli, Arcangelo Serni, Sergio Gacci, Mauro Univ Florence Careggi Hosp Unit Urol Robot Surg & Renal Transplantat Florence Italy Univ Florence Dept Expt & Clin Biomed Sci Florence Italy Chinese Univ Hong Kong SH Ho Urol Ctr Dept Surg Hong Kong Peoples R China

Introduction Standard surgical options for Benign Prostatic Hyperplasia [BPH], despite their excellent functional outcomes, are associated with multiple side effects and require general/spinal anesthesia and hospitalization. In this scenario, Transperineal Laser Ablation of the Prostate [TPLA] emerged as an ultra-minimally invasive ejaculation-sparing procedure, showing promising functional results, with a good safety profile. This systematic review aimed to provide an overview of the current role of TPLA in clinical practice, focusing on operative setting, safety, and efficacy. Evidence acquisition Literature search was performed on June 12th, 2024 using PubMed, Embase, and Cochrane Central databases, following the EAU Guidelines Office and the PRISMA statement recommendations. All studies reporting outcomes after TPLA procedures were included. Evidence synthesis Seventeen studies were included in this systematic review, of which 2 RCTs compared TPLA with TURP, 12 prospective and 3 retrospective non-randomized studies (of which 1 comparing TPLA and Prostatic Artery Embolization [PAE]). All procedures were performed using the same EchoLaserTM system (SoracteLiteTM) (Elesta s.r.l., Calenzano (FI), Italy), however great heterogeneity exists considering inclusion criteria, peri- and post-operative management. Mainly low-grade complications (Clavien-Dindo [CD] Grade <= II) were reported, while no major adverse events (CD grade > III) occurred. In all studies TPLA led to a great improvement in urinary function, up to 5 years after the procedure, while not significantly impacting erectile and ejaculatory functions. Conclusions TPLA showed promising results both in the short- and mid-term, improving urinary function while preserving sexual function and keeping a good safety profile. Since the evidence available is still limited, larger prospective comparative studies are warranted to confirm the efficacy of TPLA and to adequately compare it to standard endoscopic technique

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