Publications by authors named "Luigi Napoli"

20 Publications

  • Page 1 of 1

Role of Prophylactic Central Compartment Lymph Node Dissection on the Outcome Of Patients With Papillary Thyroid Carcinoma and Synchronous Ipsilateral Cervical Lymph Node Metastases.

Endocr Pract 2020 Aug;26(8):807-817

From the Department of Surgical, Medical, Molecular Pathology and Critical Area, Unit of Endocrine Surgery, University Hospital of Pisa, Pisa, Italy.

Objective: Prophylactic central compartment lymph node dissection (pCCND) results in a higher percentage of surgical-related complications. To date, no evidence of the impact of pCCND on the clinical outcome of papillary thyroid carcinoma (PTC) patients with synchronous ipsilateral cervical lymph node metastases has been reported.

Methods: We evaluated all consecutive patients affected by PTC and synchronous ipsilateral cervical, but without evidence of central compartment, lymph node metastases. We selected 54 consecutive patients (group A) treated by total thyroidectomy, ipsilateral cervical lymph node dissection, and pCCND and 115 patients (group B) matched for sex, age at diagnosis, number and dimension of the metastatic lateral cervical lymph nodes, without pCCND. Clinical outcome after a median of 5 years and surgical-related complications were assessed.

Results: The two groups were completely similar in terms of clinical features. Clinical outcomes showed a higher percentage of biochemical and indeterminate but not structural response in group B. Group B required significantly more radioiodine treatments, but no difference was shown in the need to repeat surgery for recurrences. Conversely, the prevalence of permanent hypoparathyroidism was significantly higher in group A (14.8%) than in group B (4.3%).

Conclusion: In PTC patients with synchronous ipsilateral cervical lymph node metastases, in absence of clinically evident lymph node metastases of the central compartment, performing pCCND does not improve the 5-year outcome in terms of structural disease, despite a greater number of I treatments. However, pCCND is severely affected by a higher percentage of permanent hypoparathyroidism, even in the hands of expert surgeons.

Abbreviations: IQR = interquartile range; pCCND = prophylactic central compartment lymph node dissection; PTC = papillary thyroid carcinoma; Tg = thyroglobulin; US = ultrasound.
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http://dx.doi.org/10.4158/EP-2019-0532DOI Listing
August 2020

Impact of Advanced Age on the Clinical Presentation and Outcome of Sporadic Medullary Thyroid Carcinoma.

Cancers (Basel) 2020 Dec 30;13(1). Epub 2020 Dec 30.

Endocrine Unit, Department of Clinical and Experimental Medicine, University Hospital of Pisa, Via Paradisa 2, 56124 Pisa, Italy.

Sporadic medullary thyroid carcinoma (MTC) is a rare malignancy with a heterogeneous clinical course. Several potential prognostic factors have been investigated, but the impact of some of these is controversial, such as age at diagnosis. We evaluated the data of 432 sporadic MTC patients followed-up for a median of 7.4 years. Patients were divided and compared according to their age at diagnosis in group A (<65 years-n = 338, 78.2%) and group B (≥65 years-n = 94, 21.8%). No differences were detected between the two groups. Median follow-up time was significantly longer in patients <65 than ≥65 years. We observed 41 (9.5%) cancer-related death events. The death rate was similar between the two age groups. However, the Kaplan Meier curve showed a longer survival time for younger patients compared to older patients [HR 2.5 (CI 95%: 1.27-4.94), < 0.01]. Nevertheless, no differences in the aggressiveness of the disease at presentation and in the number and type of treatments performed were found in the two subgroups of dead patients. In patients with sporadic MTC, age at diagnosis did not correlate with any clinical and pathological features. Cancer-related death events are similar in older and younger patients, but survival time is longer in the younger.
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http://dx.doi.org/10.3390/cancers13010094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7795457PMC
December 2020

ARIA digital anamorphosis: Digital transformation of health and care in airway diseases from research to practice.

Authors:
Jean Bousquet Josep M Anto Claus Bachert Tari Haahtela Torsten Zuberbier Wienczyslawa Czarlewski Anna Bedbrook Sinthia Bosnic-Anticevich G Walter Canonica Victoria Cardona Elisio Costa Alvaro A Cruz Marina Erhola Wytske J Fokkens Joao A Fonseca Maddalena Illario Juan-Carlos Ivancevich Marek Jutel Ludger Klimek Piotr Kuna Violeta Kvedariene Ltt Le Désirée E Larenas-Linnemann Daniel Laune Olga M Lourenço Erik Melén Joaquim Mullol Marek Niedoszytko Mikaëla Odemyr Yoshitaka Okamoto Nikos G Papadopoulos Vincenzo Patella Oliver Pfaar Nhân Pham-Thi Christine Rolland Boleslaw Samolinski Aziz Sheikh Mikhail Sofiev Charlotte Suppli Ulrik Ana Todo-Bom Peter-Valentin Tomazic Sanna Toppila-Salmi Ioanna Tsiligianni Arunas Valiulis Erkka Valovirta Maria-Teresa Ventura Samantha Walker Sian Williams Arzu Yorgancioglu Ioana Agache Cezmi A Akdis Rute Almeida Ignacio J Ansotegui Isabella Annesi-Maesano Sylvie Arnavielhe Xavier Basagaña Eric D Bateman Annabelle Bédard Martin Bedolla-Barajas Sven Becker Kazi S Bennoor Samuel Benveniste Karl C Bergmann Michael Bewick Slawomir Bialek Nils E Billo Carsten Bindslev-Jensen Leif Bjermer Hubert Blain Matteo Bonini Philippe Bonniaud Isabelle Bosse Jacques Bouchard Louis-Philippe Boulet Rodolphe Bourret Koen Boussery Fluvio Braido Vitalis Briedis Andrew Briggs Christopher E Brightling Jan Brozek Guy Brusselle Luisa Brussino Roland Buhl Roland Buonaiuto Moises A Calderon Paulo Camargos Thierry Camuzat Luis Caraballo Ana-Maria Carriazo Warner Carr Christine Cartier Thomas Casale Lorenzo Cecchi Alfonso M Cepeda Sarabia Niels H Chavannes Ekaterine Chkhartishvili Derek K Chu Cemal Cingi Jaime Correia de Sousa David J Costa Anne-Lise Courbis Adnan Custovic Biljana Cvetkosvki Gennaro D'Amato Jane da Silva Carina Dantas Dejan Dokic Yves Dauvilliers Giulia De Feo Govert De Vries Philippe Devillier Stefania Di Capua Gerard Dray Ruta Dubakiene Stephen R Durham Mark Dykewicz Motohiro Ebisawa Mina Gaga Yehia El-Gamal Enrico Heffler Regina Emuzyte John Farrell Jean-Luc Fauquert Alessandro Fiocchi Antje Fink-Wagner Jean-François Fontaine José M Fuentes Perez Bilun Gemicioğlu Amiran Gamkrelidze Judith Garcia-Aymerich Philippe Gevaert René Maximiliano Gomez Sandra González Diaz Maia Gotua Nick A Guldemond Maria-Antonieta Guzmán Jawad Hajjam Yunuen R Huerta Villalobos Marc Humbert Guido Iaccarino Despo Ierodiakonou Tomohisa Iinuma Ewa Jassem Guy Joos Ki-Suck Jung Igor Kaidashev Omer Kalayci Przemyslaw Kardas Thomas Keil Musa Khaitov Nikolai Khaltaev Jorg Kleine-Tebbe Rostislav Kouznetsov Marek L Kowalski Vicky Kritikos Inger Kull Stefania La Grutta Lisa Leonardini Henrik Ljungberg Philip Lieberman Brian Lipworth Karin C Lodrup Carlsen Catarina Lopes-Pereira Claudia C Loureiro Renaud Louis Alpana Mair Bassam Mahboub Michaël Makris Joao Malva Patrick Manning Gailen D Marshall Mohamed R Masjedi Jorge F Maspero Pedro Carreiro-Martins Mika Makela Eve Mathieu-Dupas Marcus Maurer Esteban De Manuel Keenoy Elisabete Melo-Gomes Eli O Meltzer Enrica Menditto Jacques Mercier Yann Micheli Neven Miculinic Florin Mihaltan Branislava Milenkovic Dimitirios I Mitsias Giuliana Moda Maria-Dolores Mogica-Martinez Yousser Mohammad Steve Montefort Ricardo Monti Mario Morais-Almeida Ralph Mösges Lars Münter Antonella Muraro Ruth Murray Robert Naclerio Luigi Napoli Leyla Namazova-Baranova Hugo Neffen Kristoff Nekam Angelo Neou Björn Nordlund Ettore Novellino Dieudonné Nyembue Robyn O'Hehir Ken Ohta Kimi Okubo Gabrielle L Onorato Valentina Orlando Solange Ouedraogo Julia Palamarchuk Isabella Pali-Schöll Peter Panzner Hae-Sim Park Gianni Passalacqua Jean-Louis Pépin Ema Paulino Ruby Pawankar Jim Phillips Robert Picard Hilary Pinnock Davor Plavec Todor A Popov Fabienne Portejoie David Price Emmanuel P Prokopakis Fotis Psarros Benoit Pugin Francesca Puggioni Pablo Quinones-Delgado Filip Raciborski Rojin Rajabian-Söderlund Frederico S Regateiro Sietze Reitsma Daniela Rivero-Yeverino Graham Roberts Nicolas Roche Erendira Rodriguez-Zagal Christine Rolland Regina E Roller-Wirnsberger Nelson Rosario Antonino Romano Menachem Rottem Dermot Ryan Johanna Salimäki Mario M Sanchez-Borges Joaquin Sastre Glenis K Scadding Sophie Scheire Peter Schmid-Grendelmeier Holger J Schünemann Faradiba Sarquis Serpa Mohamed Shamji Juan-Carlos Sisul Mikhail Sofiev Dirceu Solé David Somekh Talant Sooronbaev Milan Sova François Spertini Otto Spranger Cristiana Stellato Rafael Stelmach Michel Thibaudon Teresa To Mondher Toumi Omar Usmani Antonio A Valero Rudolph Valenta Marylin Valentin-Rostan Marilyn Urrutia Pereira Rianne van der Kleij Michiel Van Eerd Olivier Vandenplas Tuula Vasankari Antonio Vaz Carneiro Giorgio Vezzani Frédéric Viart Giovanni Viegi Dana Wallace Martin Wagenmann De Yun Wang Susan Waserman Magnus Wickman Dennis M Williams Gary Wong Piotr Wroczynski Panayiotis K Yiallouros Osman M Yusuf Heather J Zar Stéphane Zeng Mario E Zernotti Luo Zhang Nan Shan Zhong Mihaela Zidarn

Allergy 2021 01 23;76(1):168-190. Epub 2020 Oct 23.

University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

Digital anamorphosis is used to define a distorted image of health and care that may be viewed correctly using digital tools and strategies. MASK digital anamorphosis represents the process used by MASK to develop the digital transformation of health and care in rhinitis. It strengthens the ARIA change management strategy in the prevention and management of airway disease. The MASK strategy is based on validated digital tools. Using the MASK digital tool and the CARAT online enhanced clinical framework, solutions for practical steps of digital enhancement of care are proposed.
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http://dx.doi.org/10.1111/all.14422DOI Listing
January 2021

Minimally invasive video-assisted thyroidectomy (MIVAT).

Gland Surg 2020 Jan;9(Suppl 1):S1-S5

Department of Endocrine Surgery, University of Pisa, Pisa, Italy.

Background: Minimally invasive video-assisted thyroidectomy (MIVAT) was first described in 1999 and it has become a widespread technique performed worldwide. Although initially limited to benign thyroid nodules, MIVAT was progressively adopted for all types of thyroid diseases, while remaining within the selection criteria. It is reported that, in selected cases, MIVAT is comparable to standard open thyroidectomy (SOT) in terms of oncologic radicality, time, costs and complications rate, with the advantage of a better cosmetic result and a lower post-operative pain.

Methods: The authors conducted a retrospective analysis about patients who underwent MIVAT between 1998 and 2019 in the Endocrine Surgery Unit of the University Hospital in Pisa. Indications and contraindications are mentioned and strictly followed.

Results: Total thyroidectomy was performed in 1,862 cases (69%) and hemithyroidectomy was performed in 763 cases (28.3%). Conversion occurred in 43 cases (1.6%). In 188 cases (7%) a postoperative transient hypoparathyroidism was reported, whereas definitive hypoparathyroidism was reported in 12 cases (0.4%). Thirty-eight patients (1.4%) suffered from a definitive postoperative recurrent laryngeal nerve palsy. No definitive bilateral recurrent laryngeal nerve palsy occurred.

Conclusions: From our multi-years' experience which spreads over 20 years, we can reaffirm the concept that MIVAT is a safe procedure which is not burdened by an increase complications rate or additional costs. Furthermore, this technique offers advantages in terms of cosmetic results and post-operative pain.
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http://dx.doi.org/10.21037/gs.2019.12.05DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6995905PMC
January 2020

The Molecular Signature More Than the Site of Localization Defines the Origin of the Malignancy.

Front Oncol 2019 17;9:1390. Epub 2019 Dec 17.

Unit of Endocrinology, Department of Clinical and Experimental Medicine, Pisa University Hospital, Pisa, Italy.

The diagnosis of the primary origin of metastases to the thyroid gland is not easy, in particular in case of concomitant lung adenocarcinoma which shares several immunophenotypical features. Although rare, these tumors should be completely characterized in order to set up specific therapies. This is the case of a 64-years-old woman referred to our institution for a very advanced neoplastic disease diagnosed both as poorly differentiated/anaplastic thyroid cancer (PDTC/ATC) for the huge involvement of the neck and concomitant lung adenocarcinoma (LA). Neither the clinical features and the imaging evaluation nor the tumor markers allowed a well-defined diagnosis. Moreover, the histologic features of the thyroid and lung biopsies confirmed the synchronous occurrence of two different tumors. The molecular analysis showed a c.34G>T (p.G12C) mutation in the codon 12 of K-RAS gene, in both tissues. Since, this mutation is highly prevalent in LA and virtually absent in PDTC/ATC the lung origin of the malignancy was assumed, and the patient was addressed to the correct therapeutic strategy.
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http://dx.doi.org/10.3389/fonc.2019.01390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6928194PMC
December 2019

Next-generation ARIA care pathways for rhinitis and asthma: a model for multimorbid chronic diseases.

Authors:
J Jean Bousquet Holger J Schünemann Alkis Togias Marina Erhola Peter W Hellings Torsten Zuberbier Ioana Agache Ignacio J Ansotegui Josep M Anto Claus Bachert Sven Becker Martin Bedolla-Barajas Michael Bewick Sinthia Bosnic-Anticevich Isabelle Bosse Louis P Boulet Jean Marc Bourrez Guy Brusselle Niels Chavannes Elisio Costa Alvaro A Cruz Wienczyslawa Czarlewski Wytske J Fokkens Joao A Fonseca Mina Gaga Tari Haahtela Maddalena Illario Ludger Klimek Piotr Kuna Violeta Kvedariene L T T Le Desiree Larenas-Linnemann Daniel Laune Olga M Lourenço Enrica Menditto Joaquin Mullol Yashitaka Okamoto Nikos Papadopoulos Nhân Pham-Thi Robert Picard Hilary Pinnock Nicolas Roche Regina E Roller-Wirnsberger Christine Rolland Boleslaw Samolinski Aziz Sheikh Sanna Toppila-Salmi Ioanna Tsiligianni Arunas Valiulis Erkka Valovirta Tuula Vasankari Maria-Teresa Ventura Samantha Walker Sian Williams Cezmi A Akdis Isabella Annesi-Maesano Sylvie Arnavielhe Xavier Basagana Eric Bateman Anna Bedbrook K S Bennoor Samuel Benveniste Karl C Bergmann Slawomir Bialek Nils Billo Carsten Bindslev-Jensen Leif Bjermer Hubert Blain Mateo Bonini Philippe Bonniaud Jacques Bouchard Vitalis Briedis Christofer E Brightling Jan Brozek Roland Buhl Roland Buonaiuto Giorgo W Canonica Victoria Cardona Ana M Carriazo Warner Carr Christine Cartier Thomas Casale Lorenzo Cecchi Alfonso M Cepeda Sarabia Eka Chkhartishvili Derek K Chu Cemal Cingi Elaine Colgan Jaime Correia de Sousa Anne Lise Courbis Adnan Custovic Biljana Cvetkosvki Gennaro D'Amato Jane da Silva Carina Dantas Dejand Dokic Yves Dauvilliers Antoni Dedeu Giulia De Feo Philippe Devillier Stefania Di Capua Marc Dykewickz Ruta Dubakiene Motohiro Ebisawa Yaya El-Gamal Esben Eller Regina Emuzyte John Farrell Antjie Fink-Wagner Alessandro Fiocchi Jean F Fontaine Bilun Gemicioğlu Peter Schmid-Grendelmeir Amiran Gamkrelidze Judith Garcia-Aymerich Maximiliano Gomez Sandra González Diaz Maia Gotua Nick A Guldemond Maria-Antonieta Guzmán Jawad Hajjam John O'B Hourihane Marc Humbert Guido Iaccarino Despo Ierodiakonou Maddalena Illario Juan C Ivancevich Guy Joos Ki-Suck Jung Marek Jutel Igor Kaidashev Omer Kalayci Przemyslaw Kardas Thomas Keil Mussa Khaitov Nikolai Khaltaev Jorg Kleine-Tebbe Marek L Kowalski Vicky Kritikos Inger Kull Lisa Leonardini Philip Lieberman Brian Lipworth Karin C Lodrup Carlsen Claudia C Loureiro Renaud Louis Alpana Mair Gert Marien Bassam Mahboub Joao Malva Patrick Manning Esteban De Manuel Keenoy Gailen D Marshall Mohamed R Masjedi Jorge F Maspero Eve Mathieu-Dupas Poalo M Matricardi Eric Melén Elisabete Melo-Gomes Eli O Meltzer Enrica Menditto Jacques Mercier Neven Miculinic Florin Mihaltan Branislava Milenkovic Giuliana Moda Maria-Dolores Mogica-Martinez Yousser Mohammad Steve Montefort Ricardo Monti Mario Morais-Almeida Ralf Mösges Lars Münter Antonella Muraro Ruth Murray Robert Naclerio Luigi Napoli Leila Namazova-Baranova Hugo Neffen Kristoff Nekam Angelo Neou Enrico Novellino Dieudonné Nyembue Robin O'Hehir Ken Ohta Kimi Okubo Gabrielle Onorato Solange Ouedraogo Isabella Pali-Schöll Susanna Palkonen Peter Panzner Hae-Sim Park Jean-Louis Pépin Ana-Maria Pereira Oliver Pfaar Ema Paulino Jim Phillips Robert Picard Davor Plavec Ted A Popov Fabienne Portejoie David Price Emmanuel P Prokopakis Benoit Pugin Filip Raciborski Rojin Rajabian-Söderlund Sietze Reitsma Xavier Rodo Antonino Romano Nelson Rosario Menahenm Rottem Dermot Ryan Johanna Salimäki Mario M Sanchez-Borges Juan-Carlos Sisul Dirceu Solé David Somekh Talant Sooronbaev Milan Sova Otto Spranger Cristina Stellato Rafael Stelmach Charlotte Suppli Ulrik Michel Thibaudon Teresa To Ana Todo-Bom Peter V Tomazic Antonio A Valero Rudolph Valenta Marylin Valentin-Rostan Rianne van der Kleij Olivier Vandenplas Giorgio Vezzani Frédéric Viart Giovanni Viegi Dana Wallace Martin Wagenmann De Y Wang Susan Waserman Magnus Wickman Dennis M Williams Gary Wong Piotr Wroczynski Panayiotis K Yiallouros Arzu Yorgancioglu Osman M Yusuf Heahter J Zar Stéphane Zeng Mario Zernotti Luo Zhang Nan S Zhong Mihaela Zidarn

Clin Transl Allergy 2019 9;9:44. Epub 2019 Sep 9.

260University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

Background: In all societies, the burden and cost of allergic and chronic respiratory diseases are increasing rapidly. Most economies are struggling to deliver modern health care effectively. There is a need to support the transformation of the health care system into integrated care with organizational health literacy.

Main Body: As an example for chronic disease care, MASK (Mobile Airways Sentinel NetworK), a new project of the ARIA (Allergic Rhinitis and its Impact on Asthma) initiative, and POLLAR (Impact of Air POLLution on Asthma and Rhinitis, EIT Health), in collaboration with professional and patient organizations in the field of allergy and airway diseases, are proposing real-life ICPs centred around the patient with rhinitis, and using mHealth to monitor environmental exposure. Three aspects of care pathways are being developed: (i) Patient participation, health literacy and self-care through technology-assisted "patient activation", (ii) Implementation of care pathways by pharmacists and (iii) Next-generation guidelines assessing the recommendations of GRADE guidelines in rhinitis and asthma using real-world evidence (RWE) obtained through mobile technology. The EU and global political agendas are of great importance in supporting the digital transformation of health and care, and MASK has been recognized by DG Santé as a Good Practice in the field of digitally-enabled, integrated, person-centred care.

Conclusion: In 20 years, ARIA has considerably evolved from the first multimorbidity guideline in respiratory diseases to the digital transformation of health and care with a strong political involvement.
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http://dx.doi.org/10.1186/s13601-019-0279-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734297PMC
September 2019

Clinical, pathological and genetic features of anaplastic and poorly differentiated thyroid cancer: A single institute experience.

Oncol Lett 2018 Jun 12;15(6):9174-9182. Epub 2018 Apr 12.

Endocrine Unit, Department of Clinical and Experimental Medicine, University Hospital of Pisa, I-56124 Pisa, Italy.

Anaplastic (ATC) and poorly differentiated thyroid cancer (PDTC) are very aggressive cancers whose histological diagnosis is not always straightforward. Clinical, pathological and genetic features may be useful to improve the identification of these rare histotypes. In the present study the clinical, pathological and genetic features of two groups of ATC (n=21) and PDTC (n=21) patients were analyzed. Clinical data were retrieved from a computerized database. The oncogenic profiles were studied using the Sanger sequencing method of a selected series of oncogenes and/or tumor suppressor genes known to be altered in these tumors. The presence of macrophages in both series of tissues was evaluated by immunohistochemistry. Patients with ATC were older and affected by a more advanced disease at diagnosis than those with PDTC. The median survival was significantly shorter in ATC compared with PDTC patients (P=0.0014). ATC showed a higher prevalence of and mutations (10/21, 47.6% and 9/21, 42.8%, respectively) while and mutations were the most prevalent in the PDTC group (7/21, 33.3% and 4/23, 19% respectively). Genetic heterogeneity (i.e., >2 mutations) was more frequent in ATC (10/21, 28.6%) compared with in PDTC (3/21, 4.7%) (P=0.03). Macrophages were more frequently present in ATC, particularly in those cases with mutations. In conclusion, these data indicate that ATC and PDTC may be characterized by different clinical, pathological and genetic profiles. In particular ATC, but not PDTC, were positive for and alterations. Complex mutations were also found in ATC but not in PDTC. Moreover, genetic heterogeneity was more frequent in ATC than PDTC. Finally, mutation and the accumulation of several mutations correlated with a shorter survival time.
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http://dx.doi.org/10.3892/ol.2018.8470DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5958691PMC
June 2018

Analysis of circulating tumor DNA does not improve the clinical management of patients with locally advanced and metastatic papillary thyroid carcinoma.

Head Neck 2018 08 22;40(8):1752-1758. Epub 2018 Mar 22.

Department of Surgical, Medical, Molecular Pathology and Critical Area, University Hospital of Pisa, Pisa, Italy.

Background: Circulating cell-free tumor DNA (ctDNA) in plasma is a promising noninvasive instrument for cancer monitoring. Detection of BRAF on ctDNA of patients with papillary thyroid carcinoma (PTC) may represent an indicator of tumor aggressiveness and progression.

Methods: Eighty-three plasma samples were collected from 70 patients with thyroid nodules undergoing surgery and from 13 patients with PTC causing distant metastases. A total of 59 PTCs from both groups were evaluated for BRAF mutation on tumor tissue and on ctDNA from plasma samples by real-time polymerase chain reaction (PCR) and digital PCR.

Results: Of 59 PTCs, 22 were BRAF mutated (37.3%). The corresponding ctDNA was negative by using both techniques.

Conclusion: Although highly sensitive techniques were used, in our study, circulating BRAF alleles were never detected in the plasma of patients with PTC; therefore, our results raise the question about the clinical usefulness of BRAF analysis on ctDNA of patients with PTC.
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http://dx.doi.org/10.1002/hed.25155DOI Listing
August 2018

Prevention and management of bleeding in thyroid surgery.

Gland Surg 2017 Oct;6(5):510-515

Department of Surgery, University of Pisa, Pisa, Italy.

Post-thyroidectomy neck hematoma represents a major concern for surgeons because it can result in severe and even life-threatening complications. In fact, postoperative hemorrhage may result in airway compression and respiratory distress, and therefore, effective hemostasis is an important goal in thyroid surgery. Postoperative hematoma occurs at a rate of approximately 0.1% to 1.1%. Almost all cases occur in the first 6 h after surgery and can be the result of several surgeon or patient factors. For many years the clamp-and-tie technique has been the most common way to divide the main vascular pedicles of the thyroid gland. Alternatively, bipolar electrocautery has been used for only very small vessels. Other hemostatic systems have been introduced and proved to be potentially very useful in neck surgery and, in particular, for thyroid surgery. This new class of instruments is generally known as "energy devices" because they use different forms of energy, such as advanced bipolar (LigaSure Small Jaw Medtronic, Covidien product, Mineapolis, MN, USA) and ultrasound (Harmonic Focus; Ethicon, Johnson and Johnson, Cincinnati, OH, USA), and hybrid devices that join these two technologies (Thunderbeat by Olympus, Japan). Although they all generate a significant elevation of temperature in the tissues, as in any form of energy, the temperatures reached by these instruments are never as high as the standard monopolar electrocautery. For small bleeding very close to critical structures, where energy devices are too dangerous to be used and clamp and tie is not possible, several studies have assessed the use of adjunctive hemostatic agents. In conclusion, all energy devices have been shown to significantly decrease operative times without increasing costs or complications. Adjunctive hemostatic agents have shown equivalent differences when added to standard methods from a clinically significant perspective.
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http://dx.doi.org/10.21037/gs.2017.06.14DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5676176PMC
October 2017

Radiofrequency Ablation in the Treatment of Benign Thyroid Nodules: An Efficient and Safe Alternative to Surgery.

J Vasc Interv Radiol 2017 Oct 24;28(10):1400-1408. Epub 2017 Aug 24.

Diagnostic and Interventional Radiology-Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.

Purpose: To evaluate the efficacy and safety of radiofrequency (RF) ablation in the treatment of benign thyroid nodules (BTNs) by applying a modification of the moving-shot technique.

Materials And Methods: Fifty-one BTNs in 46 patients for whom surgery was contraindicated or who refused surgery were treated with RF ablation: 31 had lesion volumes < 20 cm (group A) and 20 had volumes ≥ 20 cm (group B). The solid component percentage of each lesion was assessed, and any present fluid component was aspirated. Symptomatic scores and cosmetic scores (CSs) were assessed. All RF ablations were performed under ultrasound (US) guidance with an 18-gauge electrode. Treatment response was evaluated by contrast-enhanced US at 6-month intervals for 18 months in group A. In group B, after the 6- and 12-month follow-up assessments, a second treatment was performed in selected cases, and the 6-month contrast-enhanced US follow-up was started again. Volume reduction rate (VRR) was evaluated at each follow-up examination.

Results: No permanent paralysis of the laryngeal nerve was observed; 2 patients experienced transient hoarseness. In all nodules treated with a single RF ablation session, the VRRs at 6, 12, and 18 months were 69.4%, 78.7%, and 84% in group A, respectively, and 66.6%, 79.4%, and 81.5% in group B, respectively. The VRRs of group B nodules treated with a second RF ablation procedure (n = 6) were 86.4% and 88.2% at 6 and 12 mo after the second treatment, respectively. All patients reported symptom relief and CS improvement.

Conclusions: RF ablation is a reliable alternative to surgery in patients affected by BTNs and can be safely repeated in selected cases.
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http://dx.doi.org/10.1016/j.jvir.2017.07.009DOI Listing
October 2017

Pancreatoduodenectomy for groove pancreatitis Report of two cases.

Ann Ital Chir 2016 ;87:433-437

Groove pancreatitis is a rare condition with patients having clinical characteristics similar to those of chronic pancreatitis. Differentiating on clinical and radiological basis between groove pancreatitis and paraduodenal head cancer can be extremely challenging. Due to diagnostic uncertainty and to poor response to medical treatment surgery may offer these patients the best chance of cure. As the main localization of the inflammatory process is at the groove between the duodenum and the head of the pancreas, pancreato-duodenectomy is proposed as the most reliable surgical procedure. We report about two patients presenting with clinical and radiological features suggesting a groove pancreatitis in which control of symptoms was achieved by pancreatoduodenectomy.

Key Words: Groove pancreatitis, Paraduodenal pancreatic cancer.
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September 2017

Nickel sensitization in patients with gastro-esophageal reflux disease.

United European Gastroenterol J 2016 Apr 24;4(2):184-90. Epub 2015 Jul 24.

General Practitioner and Gastroenterologist, Italian Group for Primary Care Gastroenterology (GIGA-CP), Italy.

Background: Gastro-esophageal reflux disease (GERD) leads to frequent medical visits, and available therapies fail in up to 40% of patients. Food allergies may be involved in GERD pathogenesis; however, allergens other than food have received little attention. Nickel allergy is common in the general population and some high-nickel foods are associated with GERD. However, the potential relationship between nickel allergy and GERD remains unaddressed.

Aim: This study aimed to evaluate the prevalence of nickel sensitization in patients with and without GERD and to compare clinical and demographic features.

Methods: This prospective, multicenter study included 210 adult GERD patients and 140 patients without GERD who presented at the general practitioner. All GERD patients had undergone treatment with proton pump inhibitors and upper digestive endoscopy within the previous five years. Demographic and clinical data were collected by questionnaire and patients underwent a nickel patch allergy test.

Results: Patients with and without GERD presented similar characteristics, with the exception of nickel sensitization, which was significantly more prevalent among GERD patients than controls (39.5% vs. 16.4%; p = 0.001). Nickel-positive GERD patients were more frequently female (90.4% vs. 65.4%, p = 0.003) and asthmatic (18.1% vs. 4.7%; p = 0.038), compared to nickel-negative GERD patients. At six-month follow-up, most of the patients, with or without nickel sensitization, reported improved symptoms without differences in drug prescription.

Conclusion: Nickel sensitization is particularly prevalent in GERD patients seen in general practice. Whether allergies other than food allergy play a role in GERD remains to be elucidated.
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http://dx.doi.org/10.1177/2050640615595917DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4804365PMC
April 2016

Indeterminate Single Thyroid Nodule: Synergistic Impact of Mutational Markers and Sonographic Features in Triaging Patients to Appropriate Surgery.

Thyroid 2016 Mar 9;26(3):390-4. Epub 2015 Dec 9.

1 Division of Surgery; University Hospital of Pisa , Pisa, Italy .

Background: Patients labeled as having indeterminate thyroid nodular disease following fine-needle aspiration cytology are at risk of non-optimal initial surgery: an overly radical total thyroidectomy, or an unnecessary two-stage operation. The objective of this study was to assess the impact of combining mutational markers and ultrasonographic (US) features preoperatively on predicting the risk of malignancy in patients with indeterminate nodules, thereby offering them a tailored initial surgical intervention.

Methods: The records of 258 patients who underwent conventional total thyroidectomy for single nodules reported as suspicious for a follicular neoplasm (Bethesda category IV) in a four-year period were reviewed. Main issues addressed included: certain US findings (individually and in combination), mutational markers (BRAF and NRAS), and combinations of both. Correlation of these with malignancy was assessed, as was their ability to predict malignancy. The usefulness of combining the absence of suspicious sonographic features and the absence of mutational markers was also evaluated.

Results: Among the 258 patients with an indeterminate diagnosis, only 90 lesions were found to be malignant. The sonographic features that correlated significantly with malignancy were irregular margins, microcalcifications, and a "taller than wide" shape. The presence of irregular margins was the feature with the highest positive predictive value. Combinations of two or more features were always associated with predictivity in excess of 90%, and at times at 100%. NRAS mutation was the most common gene alteration. Both BRAF and NRAS mutations were mutually exclusive and correlated significantly with malignancy. Their predictivity of malignancy was high, particularly when combined with suspicious sonographic features (100%). The major limitation of both suspicious sonographic features and/or mutational markers was their low occurrence in malignancy. The absence of both mutational markers and suspicious sonographic features proved extremely useful in tailoring surgical strategy, as it could have ultimately spared 143/258 patients (55%) an overly radical thyroidectomy.

Conclusion: The preoperative utility of mutational markers and sonographic features in combination has a synergistic impact. It can predict the risk of malignancy with high accuracy, properly triaging patients to appropriate surgery.
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http://dx.doi.org/10.1089/thy.2015.0311DOI Listing
March 2016

Minimally invasive video-assisted thyroidectomy (MIVAT) from A to Z.

Surg Today 2016 Feb 31;46(2):255-9. Epub 2015 Aug 31.

Department of Surgery, University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.

A minimal access procedure does not necessarily mean that it is minimally invasive. However, as its name implies, MIVAT is a truly minimally invasive treatment modality. The advantages it offers over its conventional counterpart are indeed related to its minimally invasive nature. Furthermore, this nature has not compromised its ability to accomplish its purpose both safely and effectively. Ever since its introduction in the late 1990s, MIVAT has been progressively evolving. The indications for this procedure, which was initially surrounded by skepticism, have been expanding. Benign thyroid pathology is now considered only one of its indications among others. This article provides a detailed description of this minimally invasive, maximally effective and patient satisfying procedure so that it may be adopted by more surgeons around the globe for better patient care and to also encourage the development of further future advancements.
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http://dx.doi.org/10.1007/s00595-015-1241-0DOI Listing
February 2016

Association between coeliac disease and psoriasis: Italian primary care multicentre study.

Dermatology 2015 3;230(2):156-60. Epub 2015 Feb 3.

GIGA-CP (Italian Group for Primary Care Gastroenterology), Milan, Italy.

Background: Studies assessing the association between coeliac disease (CD) and psoriasis show conflicting results.

Objective: To assess in the primary care setting the prevalence of CD in patients with psoriasis and the response to a gluten-free diet (GFD) in subjects with psoriasis and CD.

Methods: We enrolled 218 patients with psoriasis and 264 controls. Coeliac screening was carried out in all subjects (Eurospital, Trieste, Italy). In subjects with a positive serology, the diagnosis of CD was confirmed histologically.

Results: Nine (4.1%) psoriatic patients had positive anti-tissue transglutaminase antibodies compared to only 1 among controls (0.4%, p < 0.05; OR 2.03, 95% CI 1.42-90.11). The diagnosis of CD was confirmed histologically in all 10 subjects. At 6 months GFD was associated with a great improvement of skin lesions in 7 out of 8 patients with psoriasis.

Conclusion: Our multicentre primary care study showed an high prevalence of CD in psoriasis and an improvement of skin lesions in CD under GFD.
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http://dx.doi.org/10.1159/000369615DOI Listing
December 2015

Minimally invasive video-assisted thyroidectomy versus conventional thyroidectomy in pediatric patients.

Eur J Pediatr Surg 2014 Oct 2;24(5):398-402. Epub 2013 Sep 2.

Department of Surgery, University of Pisa, Pisa, Italy.

Background: Minimally invasive video-assisted thyroidectomy (MIVAT) proved to be safe and effective in the treatment of both benign and malignant disease. The aim of the present study is to compare MIVAT approach with conventional approach for total thyroidectomy in a group of 99 pediatric patients operated in the Department of General Surgery of the University of Pisa between March 2007 and July 2012.

Patients: A total of 99 pediatric patients under the age of 18 years with thyroid disease referred to our Department to undergo total thyroidectomy. Patients were divided into two groups according to the surgical technique performed: 34/99 (34.3%) patients (MIVAT group [MG]) and 65/99 (65.7%) patients, (conventional group [CG]) who underwent total thyroidectomy, respectively, with MIVAT approach and conventional approach.

Results: In MG mean operative time for total thyroidectomy was 40 ± 6.57 minutes (range 30-60 min); postoperative hospital stay was 1 day for 18 patients (53%), 2 days for 12 patients (35.25%), 3 days for 4 patients (11.8%); transient hypoparathyroidism (hypoPTH) was observed in 12 cases (35.3%) and permanent hypoPTH in 2 cases (5.9%); transient postoperative unilateral vocal cord palsy was observed in 2 patients (5.9%). In CG mean operative time for total thyroidectomy was 49.3 ± 12.9 minutes (range 30-80 min); postoperative hospital stay was 1 day for 16 patients (24.6%), 2 days for 40 patients (61.5%), 3 days for 8 patients (12.3%), and 4 days for 1 patient (1.6%); transient hypoPTH was observed in 23 cases (35.4%) and permanent hypoPTH in 4 cases (6.1%), who needed therapy with calcitriol and calcium carbonate; transient postoperative unilateral vocal cord palsy was observed in 4 patients (6.1%). There were no cases of permanent vocal cord paralysis in both groups. The correlation between two groups of patients showed that mean operative time was significantly lower in MG (p = 0.0007).

Conclusion: Pediatric patients of MG showed a significantly lower operative time and postoperative hospital stay with respect to pediatric patients of CG if compared with conventional technique. This result with the evidence of similar degree of completeness and rate of postoperative complications make MIVAT a valid option for the treatment of pediatric patients when performed by a well-trained staff in a third referral center.
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http://dx.doi.org/10.1055/s-0033-1351391DOI Listing
October 2014

Utility of noninvasive methods for the characterization of nonalcoholic liver steatosis in the family practice. The "VARES" Italian multicenter study.

Ann Hepatol 2013 Jan-Feb;12(1):70-7

Italian College of General Practitioners, Florence, Italy.

The diagnostic utilities of ultrasonography (US), fatty liver index (FLI) and an algorithm of nine serum markers (Fibromax) were evaluated in family practice to noninvasively characterize patients with nonalcoholic fatty liver disease (NAFLD). A multicenter study was conducted by enrolling 259 consecutively observed patients (age 51 ± 10 years) with clinical and ultrasonographic features of NAFLD . Patients had mild (16.2%), moderate (69.9%), or severe (13.9%) liver steatosis and 60.2% had hypertransaminasemia. The percent of patients with overweight, obesity, diabetes, hypertension, and dyslipidemia were 42.7%, 46.5% (4.2% severe obesity), 24.7%, 40.9%, and 56.4% , respectively. Lean patients (10.8%) had normal transaminases in two/thirds of the cases. A multivariate logistic regression (including age > 50 yrs, BMI > 30 kg/m2, HOMA > 3, and hypertransaminasemia) identified 12.3% of patients at risk for steatohepatitis. With a sensitivity of 50% and specificity of 94.7%, Fibromax identified 34 patients (13.1%) with likely advanced fibrosis and found that over 28% of patients with moderate (ultrasonographic) steatosis were likely to be carrying severe steatosis. Steatotest score was significantly associated with BMI, waist circumference, ALT, triglycerides, and FLI. Fibrotest correlated only with ALT. FLI identified 73.4% of patients as likely to be carrying a fatty liver. In conclusion, NAFLD should be systematically searched and characterized in all patients with metabolic disturbances and cardiovascular risk. Asymptomatic subjects at risk also should be screened for NAFLD. Fibromax is a promising noninvasive diagnostic tool in family medicine for identifying patients at risk for NAFLD who require targeted follow-up.
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June 2013

Total thyroidectomy in patients with amiodarone-induced thyrotoxicosis and severe left ventricular systolic dysfunction.

J Clin Endocrinol Metab 2012 Oct 3;97(10):3515-21. Epub 2012 Aug 3.

Department of Endocrinology and Metabolism, University of Pisa, Ospedale Cisanello, Via Paradisa, 2, 56124 Pisa, Italy.

Context: Patients with amiodarone-induced thyrotoxicosis (AIT) and left ventricular (LV) systolic dysfunction have a high mortality rate. Usually, medical therapy is the first choice for AIT patients, whereas the role of the thyroidectomy is unsettled.

Objective: The objective of the study was to evaluate the effect of a total thyroidectomy on cardiac function and survival of AIT patients with severe LV systolic dysfunction.

Design: This was a retrospective cohort study.

Settings: The study was conducted at a tertiary university center.

Patients: All AIT patients (n=24; nine patients with type 1 AIT, 15 patients with type 2 AIT) referred to the Department of Endocrinology and submitted to a total thyroidectomy at the Department of Surgery, both at the University of Pisa, during the years 1997-2010.

Intervention: The intervention was a total thyroidectomy.

Main Outcome Measure: LV ejection fraction (EF) after the thyroidectomy and survival in December 2011 were measured.

Results: All enrolled patients had previously undergone to medical treatment for AIT, as appropriate, without achieving euthyroidism. Patients with moderate to severe LV systolic dysfunction (EF<40%, group 1, n=9) or with mild systolic dysfunction (40%≤EF≤50%, group 2, n=5) were compared with patients with normal systolic function (EF>50%, group 3, n=10). Two months after thyroidectomy, under levothyroxine replacement therapy, LVEF improved in patients with LV systolic dysfunction, particularly in those of group 1, in whom it increased from 28.2±7.2 to 38.3±6% (P=0.007). On the contrary, LVEF did not significantly change in group 3 (from 57.1±3.0 to 59.8±6.6%, P=0.242). The mean follow-up was 67±42 months. No death occurred during and 2 months after surgery. One death occurred in one patient of group 1, 30 months after the thyroidectomy, due to acute myocardial infarction. No patient had relevant complications of thyroidectomy.

Conclusions: Total thyroidectomy, by rapidly restoring euthyroidism, may improve cardiac function and reduce the risk of mortality in AIT patients with severe LV dysfunction.
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http://dx.doi.org/10.1210/jc.2012-1797DOI Listing
October 2012

Proton pump inhibitors prescribing following the introduction of generic drugs.

Eur J Clin Invest 2012 Oct 9;42(10):1068-78. Epub 2012 Jun 9.

CIRFF - Center of Pharmacoeconomics and Drug Utilization, Faculty of Pharmacy, University of Naples 'Federico II', Naples, Italy.

Background: In many countries, the introduction of generic proton pump inhibitors (PPIs) onto the pharmaceutical market increased the phenomenon of therapeutic substitution in acid-related disorders (ARDs).

Aim: To investigate the treatment of ARDs in an Italian primary care setting from 2005 to 2008 by verifying: (i) dynamics of PPI prescribing; (ii) predictors of PPI switching; and (iii) healthcare resource consumption costs.

Methods: This was a retrospective cohort study of 102 general practitioners (GPs) who managed an average of 150000 inhabitants in Naples. Multilevel logistic regression was used to assess the potential predictors of both PPI switching and termination. Primary care costs were expressed as the cost of ARD management per PPI user year.

Results: The percentage of PPI users with ARD increased from 5·5% (2005) to 7·0% (2008) (P<0·0001), especially for dyspepsia (from 9·5% to 13·7%; P<0·0001) and chronic treatments (from 23·4% to 29·4%; P<0·0001). PPI switching rose from 13·0% to 16·7% during the period observed (P<0·0001). Calendar years, long-term treatments and gastroesophageal reflux disease were positive predictors of PPI switching. Primary care costs relating to PPI switchers increased by 61·14€ compared with nonswitchers (P<0·0001).

Conclusions: The introduction of generic PPIs onto the Italian market was associated with an increasing amount of PPI prescribing related to chronic treatments, unlicensed indications (e.g. dyspespsia) and therapeutic substitutions. Growing overall costs linked to the phenomenon of PPI switching was also found. Our data support the need to assess the effects of the introduction of generic drugs on both clinical outcomes and the cost management of ARDs.
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http://dx.doi.org/10.1111/j.1365-2362.2012.02696.xDOI Listing
October 2012

Management of chronic liver disease by general practitioners in southern Italy: unmet educational needs.

Dig Liver Dis 2011 Sep 25;43(9):736-41. Epub 2011 May 25.

Interuniversity Center for Research on Food, Nutrition and Digestive Tract, Gastroenterology School Second University, Naples, Italy.

Background: Despite chronic liver diseases represent an important cause of illness in Italy, data from family practice are poor.

Aim: To assess the management of chronic liver diseases by general practitioners in a large area of Southern Italy.

Methods: This was a 5-year retrospective analysis from 104 physicians in charge of a population of 143,159 adult subjects.

Results: Amongst 6550 patients with chronic liver disease (4.7%, 3400 M, median age 57 years), 1330 (20.3%) had HCV infection, 226 (3.4%) HBV infection, and 293 (4.5%) liver cirrhosis (25 alcohol-related). The prevalence of alcohol consumption, recorded by 90% of physicians, was 20.4%. Hypertransaminasemia and liver steatosis had a prevalence of 6.7% and 2.4%, respectively. Although transaminases were checked 3 times over 5 years in 80% of cases, few patients were investigated for viral infection, and less than 50% underwent ultrasonography and consultation, leaving undefined a consistent number of cases. Alcohol consumption, body mass index and ultrasonography were poorly checked even in hypertransaminasemic patients.

Conclusions: This study shows that data recording by general practitioners in chronic liver disease patients lacks homogeneity and can miss important information. One unmet need is therefore the integration between theoretical knowledge and practice to share similar behaviours and improve the management of these patients.
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http://dx.doi.org/10.1016/j.dld.2011.04.013DOI Listing
September 2011