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4. Patient-Reported Outcomes and Return to Intended Oncologic Therapy After Colorectal Enhanced Recovery Pathway

Author

The Italian ColoRectal Anastomotic Leakage (iCral3) study group, Marco Catarci, MD, FACS, Giacomo Ruffo, MD, Massimo Giuseppe Viola, MD, Ferdinando Ficari, MD, Paolo Delrio, MD, Felice Pirozzi, MD, Felice Borghi, MD, Raffaele De Luca, MD, Alberto Patriti, MD, Gianluca Garulli, MD, Walter Siquini, MD, Stefano D’Ugo, MD, PhD, FEBS, FACS, Stefano Scabini, MD, Marco Caricato, MD, FACS, Giusto Pignata, MD, Andrea Liverani, MD, Roberto Campagnacci, MD, Pierluigi Marini, MD, Ugo Elmore, MD, Francesco Corcione, MD, Roberto Santoro, MD, Massimo Carlini, MD, FACS, Antonio Giuliani, MD, Mario Sorrentino, MD, Giovanni Ferrari, MD, Gianandrea Baldazzi, MD, Alberto Di Leo, MD, Augusto Verzelli, MD, Giuseppe Sica, MD, Stefano Rausei, MD, Davide Cavaliere, MD, Gian Luca Baiocchi, MD, FACS, Marco Milone, MD, Giovanni Ciaccio, MD, Giovanni Domenico Tebala, MD, FACS, FRCS, Marco Scatizzi, MD, Luigi Boni, MD, FACS, Stefano Mancini, MD, Mario Guerrieri, MD, Roberto Persiani, MD, Andrea Lucchi, MD, FACS, Dario Parini, MD, Antonino Spinelli, MD, Michele Genna, MD, Vincenzo Bottino, MD, Andrea Coratti, MD, Dario Scala, MD, Andrea Muratore, MD, Maurizio Pavanello, MD, Umberto Rivolta, MD, Micaela Piccoli, MD, FACS, Carlo Talarico, MD, Alessandro Carrara, MD, Stefano Guadagni, MD, Mauro Totis, MD, Franco Roviello, MD, Alessandro Anastasi, MD, Gianluca Guercioni, MD, Giuseppe Maria Ettorre, MD, Mauro Montuori, MD, Pierpaolo Mariani, MD, Nicolò de Manzini, MD, Annibale Donini, MD, Mariano Fortunato Armellino, MD, Lucio Taglietti, MD, Gabriele Anania, MD, Mariantonietta Di Cosmo, MD, Carlo Vittorio Feo, MD, Paolo Millo, MD, Corrado Pedrazzani, MD, Silvio Guerriero, MD, Andrea Costanzi, MD, Nereo Vettoretto, MD, Federico Marchesi, MD, Massimo Basti, MD, Graziano Longo, MD, Moreno Cicetti, MD, Paolo Ciano, MD, Michele Benedetti, MD, Leonardo Antonio Montemurro, MD, Maria Sole Mattei, MD, Elena Belloni, MD, Elisa Bertocchi, MD, Gaia Masini, MD, Amedeo Altamura, MD, Francesco Rubichi, MD, Francesco Giudici, MD, Fabio Cianchi, MD, Gabriele Baldini, MD, Ugo Pace, MD, Andrea Fares Bucci, MD, Antonio Sciuto, MD, Desirée Cianflocca, MD, Marco Migliore, MD, Michele Simone, MD, Marcella Lodovica Ricci, MD, Francesco Monari, MD, Alessandro Cardinali, MD, Massimo Sartelli, MD, Marcello Spampinato, MD, PhD, FEBS (HPB), Alessandra Aprile, MD, Domenico Soriero, MD, Gabriella Teresa Capolupo, MD, FACS, Jacopo Andreuccetti, MD, Ilaria Canfora, MD, Andrea Scarinci, MD, Angela Maurizi, MD, Grazia Maria Attinà, MD, Giulia Maggi, MD, Umberto Bracale, MD, Roberto Peltrini, MD, Pietro Amodio, MD, Domenico Spoletini, MD, PhD, FACS, Rosa Marcellinaro, MD, Giovanni Del Vecchio, MD, Massimo Stefanoni, MD, Carmelo Magistro, MD, Diletta Cassini, MD, Lorenzo Crepaz, MD, Andrea Budassi, MD, Bruno Sensi, MD, Silvia Tenconi, MD, Leonardo Solaini, MD, Giorgio Ercolani, MD, Sarah Molfino, MD, Giovanni Domenico De Palma, MD, Paolo Locurto, MD, Antonio Di Cintio, MD, Lorenzo Pandolfini, MD, Alessandro Falsetto, MD, Elisa Cassinotti, MD, Andrea Sagnotta, MD, PhD, Monica Ortenzi, MD, Alberto Biondi, MD, Giacomo Martorelli, MD, Maurizio De Luca, MD, Francesco Carrano, MD, Annalisa Maroli, PhD, Francesca Fior, MD, Antonio Ferronetti, MD, Giuseppe Giuliani, MD, Roberto Benigni, MD, Graziella Marino, MD, Patrizia Marsanic, MD, Nicoletta Sveva Pipitone Federico, MD, Carlo Di Marco, MD, Camillo Leonardo Bertoglio, MD, PhD, Francesca Pecchini, MD, Vincenzo Greco, MD, Michele Motter, MD, Giuseppe Tirone, MD, Marco Clementi, MD, Nicolò Tamini, MD, Riccardo Piagnerelli, MD, Giuseppe Canonico, MD, Simone Cicconi, MD, Marco Colasanti, MD, Enrico Pinotti, MD, Roberta Carminati, MD, Edoardo Osenda, MD, Luigina Graziosi, MD, Ciro De Martino, MD, Giovanna Ioia, MD, Arianna Birindelli, MD, Matteo Chiozza, MD, Daniele Zigiotto, MD, Fioralba Pindozzi, MD, Manuela Grivon, MD, Cristian Conti, MD, Lorenzo Organetti, MD, Michela Monteleone, MD, Emanuele Botteri, MD, Giorgio Dalmonte, MD, Diletta Frazzini, MD, Simone Santoni, MD, Gabriele La Gioia, MD, and Diana Giannarelli, MS, PhD

Subjects
Surgery, RD1-811
Abstract

Objective:. To evaluate the influence of enhanced recovery pathway (ERP) on patient-reported outcome measures (PROMs) and return to intended oncologic therapy (RIOT) after colorectal surgery. Background:. ERP improves early outcomes after colorectal surgery; however, little is known about its influence on PROMs and on RIOT. Methods:. Prospective multicenter enrollment of patients who underwent colorectal resection with anastomosis was performed, recording variables related to patient-, institution-, procedure-level data, adherence to the ERP, and outcomes. The primary endpoints were PROMs (administered before surgery, at discharge, and 6 to 8 weeks after surgery) and RIOT after surgery for malignancy, defined as the intended oncologic treatment according to national guidelines and disease stage, administered within 8 weeks from the index operation, evaluated through multivariate regression models. Results:. The study included 4529 patients, analyzed for PROMs, 1467 of which were analyzed for RIOT. Compared to their baseline preoperative values, all PROMs showed significant worsening at discharge and improvement at late evaluation. PROMs values at discharge and 6 to 8 weeks after surgery, adjusted through a generalized mixed regression model according to preoperative status and other variables, showed no association with ERP adherence rates. RIOT rates (overall 54.5%) were independently lower by aged > 69 years, ASA Class III, open surgery, and presence of major morbidity; conversely, they were independently higher after surgery performed in an institutional ERP center and by ERP adherence rates > median (69.2%). Conclusions:. Adherence to the ERP had no effect on PROMs, whereas it independently influenced RIOT rates after surgery for colorectal cancer.

Published
2023
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5. A New Score to Assess the Perioperative Period of the Cancer Patient Undergoing Non-Palliative Elective Surgery: A Retrospective Evaluation of a Case Report by PERIDIA Score

Author

Letizia Andresciani, Concetta Calabrò, Mariarita Laforgia, Maria Ronchi, Simona De Summa, Christel Cariddi, Rosa Boccuzzi, Anna De Rosa, Elisabetta Rizzo, Giulia Losito, Grazia Bradascio, Gaetano Napoli, Michele Simone, Giuseppe Carravetta, and Giovanni Mastrandrea

Subjects
perioperative score, peridiaphragmatic surgery, anesthesiology, ICU, cancer patients, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

The complexity of cancer patients and the use of advanced and demolitive surgical techniques frequently need post-operatory ICU hospitalization. To increase safety and to select the best medical strategies for the patient, a multidisciplinary team has performed a new peri-operatory assessment, arising from evidence-based literature data. Verifying that most of the cancer patients, admitted to the intensive care unit, undergo major surgery with localizations in the supramesocolic thoraco-abdominal area, the team focused the attention on supramesocolic peridiaphragmatic cancer surgery. Some scores already in use in clinical practice were selected for the peri-operatory evaluation process. None of them evaluate parameters relating to the entire peri-operative period. In detail, only a few study models were found that concern the assessment of the intra-operative period. Therefore, we wanted to see if using a mix of validated scores, it was possible to build a single evaluation score (named PERIDIAphragmatic surgery score or PERIDIA-score) for the entire peri-operative period that could be obtained at the end of the patient’s hospitalization period in post-operative ICU. The main property sought with the creation of the PERIDIA-score is the proportionality between the score and the incidence of injuries, deaths, and the length of stay in the ward. This property could organize a tailor-made therapeutic path for the patient based on pre-rehabilitation, physiotherapy, activation of social assistance services, targeted counseling, collaborations with the continuity of care network. Furthermore, if the pre-operative score is particularly high, it could suggest different or less invasive therapeutic options, and if the intra-operative score is particularly high, it could suggest a prolongation of hospitalization in ICU. The retrospective prospective study conducted on 83 patients is still ongoing. The first data would seem to prove an increase of clinical complications in patients who were assigned a one-third score with respect to the maximum (16/48) of PERIDIA-score. Moreover, patients with a 10/16 score within each phase of the evaluation (pre, peri, and post) more frequently develop injuries. In the light of these evidence, the 29-point score assigned to our patient can be considered as predictive for the subsequent critical and fatal complications the patient faced up.

Published
2021
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6. Remote mentoring in laparotomic and laparoscopic cancer surgery during Covid-19 pandemic: an experimental setup based on mixed reality

Author

Michele Simone, Rocco Galati, Graziana Barile, Emanuele Grasso, Raffaele De Luca, Carmine Cartanese, Rocco Lomonaco, Eustachio Ruggieri, Anna Albano, Antonello Rucci, and Giuseppe Grassi

Subjects
virtual reality, mixed reality, laparotomic surgery, smartglasses, laparoscopic surgery, Special aspects of education, LC8-6691, Medicine (General), R5-920
Abstract

In this paper, Mixed Reality (MR) has been exploited in the operating rooms to perform laparoscopic and open surgery with the aim of providing remote mentoring to the medical doctors under training during the Covid-19 pandemic. The employed architecture, which has put together MR smartglasses, a Digital Imaging Player, and a Mixed Reality Toolkit, has been used for cancer surgery at the IRCCS Hospital ‘Giovanni Paolo II’ in southern Italy. The feasibility of using the conceived platform for real-time remote mentoring has been assessed on the basis of surveys distributed to the trainees after each surgery.

Published
2021
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7. The Interaction between Reactive Peritoneal Mesothelial Cells and Tumor Cells via Extracellular Vesicles Facilitates Colorectal Cancer Dissemination

Author

Simona Serratì, Letizia Porcelli, Francesco Fragassi, Marianna Garofoli, Roberta Di Fonte, Livia Fucci, Rosa Maria Iacobazzi, Antonio Palazzo, Francesca Margheri, Grazia Cristiani, Anna Albano, Raffaele De Luca, Donato Francesco Altomare, Michele Simone, and Amalia Azzariti

Subjects
colorectal cancer, peritoneal carcinomatosis, CD44, mesothelial cells, MMT, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Advanced colorectal cancer (CRC) is highly metastatic and often results in peritoneal dissemination. The extracellular vesicles (EVs) released by cancer cells in the microenvironment are important mediators of tumor metastasis. We investigated the contribution of EV-mediated interaction between peritoneal mesothelial cells (MCs) and CRC cells in generating a pro-metastatic environment in the peritoneal cavity. Peritoneal MCs isolated from peritoneal lavage fluids displayed high CD44 expression, substantial mesothelial-to-mesenchymal transition (MMT) and released EVs that both directed tumor invasion and caused reprogramming of secretory profiles by increasing TGF-β1 and uPA/uPAR expression and MMP-2/9 activation in tumor cells. Notably, the EVs released by tumor cells induced apoptosis by activating caspase-3, peritoneal MC senescence, and MMT, thereby augmenting the tumor-promoting potential of these cells in the peritoneal cavity. By using pantoprazole, we reduced the biogenesis of EVs and their pro-tumor functions. In conclusion, our findings provided evidence of underlying mechanisms of CRC dissemination driven by the interaction of peritoneal MCs and tumor cells via the EVs released in the peritoneal cavity, which may have important implications for the clinical management of patients.

Published
2021
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9. Quality of Life in Older Adults After Major Cancer Surgery: The GOSAFE International Study

Author

Montroni, Isacco, Ugolini, Giampaolo, Saur, Nicole M, Rostoft, Siri, Spinelli, Antonino, Van Leeuwen, Barbara L, De Liguori Carino, Nicola, Ghignone, Federico, Jaklitsch, Michael T, Somasundar, Ponnandai, Garutti, Anna, Zingaretti, Chiara, Foca, Flavia, Vertogen, Bernadette, Nanni, Oriana, Wexner, Steven D, Audisio, Riccardo, A Giovanni Taffurelli, Davide, Zattoni, Paola, Tramelli, Giacomo, Sermonesi, Giorgio, Ercolani, Francesca, Tauceri, Barbara, Perenze, Daniela Di Pietrantonio, Mariateresa, Mirarchi, Gianluca, Garulli, Vincenzo, Alagna, Lucchi, Andrea, Basilio, Pirrera, Francesco, Monari, Luigi, Conti, Patrizio, Capelli, Andrea, Romboli, Gerardo, Palmieri, Filippo, Banchini, Francesca Di Candido, Michele, Carvello, Matteo, Sacchi, DE LUCIA, Francesca, Caterina, Foppa, Luigi, Marano, Spaziani, Alessandro, Giampaolo, Castagnoli, Bartoli, Alberto, Laura, Frain, Sam, W Fox, Kristin, Cardin, Luis, E De Leon, Mario, Trompetto, Gallo, Gaetano, Alberto Realis Luc, Giuseppe, Clerico, Giuseppe, Sammarco, Raffaele De Luca, Michele, Simone, Rocco, Lomonaco, Michael, Fejka, Joshua I, S Bleier, Matthijs, Plas, Hanneke van der Wal-Huisman, Andrea, Costanzi, Giulio, Mari, Dario, Maggioni, Pellegrino, Roberta, Pietro, Ascheri, Jakub, Kenig, Kinga, Szabat, Stefano, Scabini, Davide, Pertile, Lorenzo, Epis, Andrea, Massobrio, Domenico, Soriero, Arild, Nesbakken, Ingeborg Flåten Backe, Mariann, Lønn, Ferrari, Giovanni, Michele, Mazzola, Carmelo, Magistro, Pietro, Achilli, Alessandro, Giani, Orestis, Ioannidis, Lydia, Loutzidou, Konstantinos, Galanos-Demiris, Balducci, Genoveffa, Frezza, Barbara, Lucarini, Alessio, Claudia, Santos, Diogo, Cardoso, Isabela, Gil, Vasco, Cardoso, Lisa, Cooper, Baha, Siam, Yochai, Levy, Baruch, Brenner, Hanoch, Kashtan, Valerio, Belgrano, Franco, Decian, Beatrice, Palermo, Roberto, Eggenhöffner, Manuela, Albertelli, Luis, Sánchez-Guillén, Antonio, Arroyo, Francisco, López-Rodríguez, Sandra, Lario, DI LILLO, Cristina, Minas, Baltatzis, Anthony K, C Chan, Ajith, K Siriwardena, Giovanna Da Silva, Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)

Subjects
Cancer Research, aged, Oncology, male, quality of life, geriatric assessment, 80 and over, neoplasms, pain, frailty, humans, aged, 80 and over
Abstract

Background Accurate quality of life (QoL) data and functional results after cancer surgery are lacking for older patients. The international, multicenter Geriatric Oncology Surgical Assessment and Functional rEcovery after Surgery (GOSAFE) Study compares QoL before and after surgery and identifies predictors of decline in QoL. Methods GOSAFE prospectively collected data before and after major elective cancer surgery on older adults (≥70 years). Frailty assessment was performed and postoperative outcomes recorded (30, 90, and 180 days postoperatively) together with QoL data by means of the three-level version of the EuroQol five-dimensional questionnaire (EQ-5D-3L), including 2 components: an index (range = 0-1) generated by 5 domains (mobility, self-care, ability to perform the usual activities, pain or discomfort, anxiety or depression) and a visual analog scale. Results Data from 26 centers were collected (February 2017-March 2019). Complete data were available for 942/1005 consecutive patients (94.0%): 492 male (52.2%), median age 78 years (range = 70-95 years), and primary tumor was colorectal in 67.8%. A total 61.2% of all surgeries were via a minimally invasive approach. The 30-, 90-, and 180-day mortality was 3.7%, 6.3%, and 9%, respectively. At 30 and 180 days, postoperative morbidity was 39.2% and 52.4%, respectively, and Clavien-Dindo III-IV complications were 13.5% and 18.7%, respectively. The mean EQ-5D-3L index was similar before vs 3 months but improved at 6 months (0.79 vs 0.82; P Conclusions GOSAFE shows that older adults’ preoperative QoL is preserved 3 months after cancer surgery, independent of their age. Frailty screening tools, patient-reported outcomes, and goals-of-care discussions can guide decisions to pursue surgery and direct patients’ expectations.

Published
2022

10. Risk factors for anastomotic leakage after anterior resection for rectal cancer (RALAR study): A nationwide retrospective study of the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group

Author

Maurizio, Degiuli, Ugo, Elmore, Raffaele De Luca, Paola De Nardi, Mariano, Tomatis, Alberto, Biondi, Roberto, Persiani, Leonardo, Solaini, Gianluca, Rizzo, Domenico, Soriero, Desiree, Cianflocca, Marco, Milone, Giulia, Turri, Daniela, Rega, Paolo, Delrio, Corrado, Pedrazzani, De Palma, Giovanni D., Felice, Borghi, Stefano, Scabini, Claudio, Coco, Davide, Cavaliere, Michele, Simone, Riccardo, Rosati, Rossella, Reddavid, Francesco, Evola, Michela, Mineccia, Francesca, Pecchini, Gallo, G, Paola, Incollingo, Fabio, Maiello, Andrea, Barberis, Monica, Ortenzi, Vittoria, Bellato, Caterina, Foppa, Vincenzo, Adamo, Cristina, Bombardini, Alessandro, Giuliani, Francesca, Cravero, Marco, Amisano, Pietro Paolo Bianchi, Gabriele, Anania, Marco, Calgaro, Antonino, Spinelli, Giuseppe, S Sica, Marito, Guerrieri, Marco, Filauro, Roberto, Polastri, Francesco, Bianco, Giuseppe, Sammarco, Micaela, Piccoli, Alessandro, Ferrero, Domenico, D'Ugo, Degiuli, Maurizio, Elmore, Ugo, De Luca, Raffaele, De Nardi, Paola, Tomatis, Mariano, Biondi, Alberto, Persiani, Roberto, Solaini, Leonardo, Rizzo, Gianluca, Soriero, Domenico, Cianflocca, Desiree, Milone, Marco, Turri, Giulia, Rega, Daniela, Delrio, Paolo, Pedrazzani, Corrado, De Palma, Giovanni D, Borghi, Felice, Scabini, Stefano, Coco, Claudio, Cavaliere, Davide, Simone, Michele, Rosati, Riccardo, and Reddavid, Rossella

Subjects
Leak, medicine.medical_specialty, Colorectal cancer, Anastomotic Leak, Anastomosis, Stoma, colorectal fistula, colorectal leakage, rectal cancer, rectal surgery, stoma, Rare Diseases, Risk Factors, Surgical oncology, medicine, Humans, Rectal cancer, Retrospective Studies, Models, Statistical, Rectal Neoplasms, business.industry, Incidence (epidemiology), Anastomosis, Surgical, Gastroenterology, Retrospective cohort study, Nomogram, Prognosis, medicine.disease, Surgery, Settore MED/18, Surgical Oncology, business
Abstract

Aim: Anastomotic leakage after restorative surgery for rectal cancer shows high morbidity and related mortality. Identification of risk factors could change operative planning, with indications for stoma construction. This retrospective multicentre study aims to assess the anastomotic leak rate, identify the independent risk factors and develop a clinical prediction model to calculate the probability of leakage. Methods: This study used data from 24 Italian referral centres of theColorectal Cancer Network of the Italian Society of Surgical Oncology. Patients were classified into two groups, AL (anastomotic leak) or NoAL (no anastomotic leak). The effect ofpatient-, disease-, treatment- and postoperative outcome-related factors on anastomotic leak after uni- and multivariable analysis was measured. Results: A total of 5398 patients were included, 552 in group AL and 4846 in group NoAL. The overall incidence of leaks was 10.2%, with a mean time interval of 6.8 days. The 30-day leak-related mortality was 2.6%. Sex, BMI, No cartridges, operating time, type of approach, tumour location, combined multiorgan resection, pT and pN, were identified as independent risk factors. The stoma didn't reduce the leak rate, but significantly decreased leak severity and reoperation rate. A nomogram with a risk-score (RALARscore) was developed to predict anastomotic leak risk at the end of resection. Conclusions: While a defunctioning stoma did not affect the leak risk, it significantly reduced its severity. Surgeons should recognize independent risk factors for leaks at the end of rectal resection, and could calculate a risk-score to select high-risk patients eligible for protective stoma construction.

Published
2022

11. Current practice on the use of prophylactic drain after gastrectomy in Italy: the Abdominal Drain in Gastrectomy ({ADiGe}) survey

Author

Mengardo, Valentina, Weindelmayer, Jacopo, Veltri, Alessandro, Giacopuzzi, Simone, Torroni, Lorena, DE MANZONI, Giovanni, Ferdinando, Agresta, Rita, Alfieri, Sergio, Alfieri, Nicola, Antonacci, Gian Luca Baiocchi, Lapo, Bencini, Bencivenga, Maria, Benedetti, Michele, Mattia, Berselli, Alberto, Biondi, Gabriella Teresa Capolupo, Fabio, Carboni, Riccardo, Casadei, Casella, Francesco, Catarci, Marco, Paolo, Cerri, Damiano, Chiari, Eugenio, Cocozza, Giovanni, Colombo, Luca, Cozzaglio, Giorgio, Dalmonte, Maurizio, Degiuli, Maurizio De Luca, Raffaele De Luca, Nicol(`(o)) De Manzini, DE PASQUAL, CARLO ALBERTO, Stefano De Pascale, Nicola De Ruvo, DI COSMO, Mariantonietta, DI LEO, Alberto, Massimiliano Di Paola, Amedeo, Elio, Francesco, Ferrara, Giovanni, Ferrari, Valentino, Fiscon, Uberto, Fumagalli, Gianluca, Garulli, Andrea, Gennai, Irene, Gentile, Paola, Germani, Monica, Gualtierotti, Guerini, Francesca, Angela, Gurrado, Inama, Marco, Filippo La Torre, Ernesto, Laterza, Pasquale, Losurdo, Antonio, Macr(`(i)), Alessandra, Marano, Luigi, Marano, Federico, Marchesi, Fabio, Marino, Marco, Massani, Roberta, Menghi, Marco, Milone, Sarah, Molfino, Mauro, Montuori, Moretto, Gianluigi, Paolo, Morgagni, Emilio, Morpurgo, Moukchar, Abdallah, Luca, Nespoli, Stefano, Olmi, Raffaele, Palaia, Giovanni, Pallabazer, Parise, Paolo, Alessandro, Pasculli, Marco Pericoli Ridolfini, Antonio, Pesce, Enrico, Pinotti, Michele, Pisano, Elia, Poiasina, Vittorio, Postiglione, Stefano, Rausei, Antonio, Rella, Fausto, Rosa, Riccardo, Rosati, Gianmaria, Rossi, Luca, Rossit, Massimo, Rovatti, Laura, Ruspi, DAL SACCO, Luca, Saladino, Edoardo, Andrea, Sansonetti, Sartori, Alberto, Donatella, Scaglione, Stefano, Scaringi, Christian, Schoenthaler, Giuseppe, Sena, Michele, Simone, Leonardo, Solaini, Paolo, Strignano, Nicola, Tartaglia, Silvio, Testa, Mario, Testini, Guido Alberto Massimo Tiberio, Treppiedi, Elio, Alessio, Vagliasindi, Michele, Valmasoni, Jacopo, Vigan(`(o)), Gianpietro, Zanchettin, Andrea, Zanoni, Zardini, Claudio, Antonio Zerbinati and, Mengardo, V, Weindelmayer, J, Veltri, A, Giacopuzzi, S, Torroni, L, de Manzoni, G, Agresta, F, Alfieri, R, Alfieri, S, Antonacci, N, Baiocchi, G, Bencini, L, Bencivenga, M, Benedetti, M, Berselli, M, Biondi, A, Capolupo, G, Carboni, F, Casadei, R, Casella, F, Catarci, M, Cerri, P, Chiari, D, Cocozza, E, Colombo, G, Cozzaglio, L, Dalmonte, G, Degiuli, M, De Luca, M, De Luca, R, De Manzini, N, De Pasqual, C, De Pascale, S, De Ruvo, N, Di Cosmo, M, Di Leo, A, Di Paola, M, Elio, A, Ferrara, F, Ferrari, G, Fiscon, V, Fumagalli, U, Garulli, G, Gennai, A, Gentile, I, Germani, P, Gualtierotti, M, Guerini, F, Gurrado, A, Inama, M, La Torre, F, Laterza, E, Losurdo, P, Macri, A, Marano, A, Marano, L, Marchesi, F, Marino, F, Massani, M, Menghi, R, Milone, M, Molfino, S, Montuori, M, Moretto, G, Morgagni, P, Morpurgo, E, Abdallah, M, Nespoli, L, Olmi, S, Palaia, R, Pallabazer, G, Parise, P, Pasculli, A, Pericoli Ridolfini, M, Pesce, A, Pinotti, E, Pisano, M, Poiasina, E, Postiglione, V, Rausei, S, Rella, A, Rosa, F, Rosati, R, Rossi, G, Rossit, L, Rovatti, M, Ruspi, L, Sacco, L, Saladino, E, Sansonetti, A, Sartori, A, Scaglione, D, Scaringi, S, Schoenthaler, C, Sena, G, Simone, M, Solaini, L, Strignano, P, Tartaglia, N, Testa, S, Testini, M, Tiberio, G, Treppiedi, E, Vagliasindi, A, Valmasoni, M, Vigano, J, Zanchettin, G, Zanoni, A, Zardini, C, Zerbinati, A, Mengardo, Valentina, Weindelmayer, Jacopo, Veltri, Alessandro, Giacopuzzi, Simone, Torroni, Lorena, de Manzoni, Giovanni, and de Manzini, Nicolo

Subjects
Surgeons, Postoperative Complications, Gastrectomy, Stomach Neoplasms, Surveys and Questionnaires, Drain, Drainage, Gastric cancer, Survey, Humans, Surgery
Abstract

Evidence against the use of prophylactic drain after gastrectomy are increasing and ERAS guidelines suggest the benefit of drain avoidance. Nevertheless, it is unclear whether this practice is still widespread. We conducted a survey among Italian surgeons through the Italian Gastric Cancer Research Group and the Polispecialistic Society of Young Surgeons, aiming to understand the current use of prophylactic drain. A 28-item questionnaire-based survey was developed to analyze the current practice and the individual opinion about the use of prophylactic drain after gastrectomy. Groups based on age, experience and unit volume were separately analyzed. Response of 104 surgeons from 73 surgical units were collected. A standardized ERAS protocol for gastrectomy was applied by 42% of the respondents. Most of the surgeons, regardless of age, experience, or unit volume, declared to routinely place one or more drain after gastrectomy. Only 2 (1.9%) and 7 surgeons (6.7%) belonging to high volume units, do not routinely place drains after total and subtotal gastrectomy, respectively. More than 60% of the participants remove the drain on postoperative day 4–6 after performing an assessment of the anastomosis integrity. Interestingly, less than half of the surgeons believe that drain is the main tool for leak management, and this percentage further drops among younger surgeons. On the other hand, drain’s role seems to be more defined for duodenal stump leak treatment, with almost 50% of the surgeons recognizing its importance. Routine use of prophylactic drain after gastrectomy is still a widespread practice even if younger surgeons are more persuaded that it could not be advantageous.

Published
2022

12. ERAS program adherence-institutionalization, major morbidity and anastomotic leakage after elective colorectal surgery: the iCral2 multicenter prospective study

Author

Marco, Catarci, Giacomo, Ruffo, Massimo, Giuseppe, Viola, Felice, Pirozzi, Paolo, Delrio, Felice, Borghi, Gianluca, Garulli, Gianandrea, Baldazzi, Pierluigi, Marini, Giuseppe, Sica, Gianluca, Guercioni, Paolo, Ciano, Michele, Benedetti, Simone, Cicconi, Irene, Marziali, Elisa, Bertocchi, Amedeo, Altamura, Francesco, Rubichi, Antonio, Sciuto, Ugo, Pace, Andrea Fares Bucci, Desirée, Cianflocca, Marco, Migliore, Basilio, Pirrera, Vincenzo, Alagna, Diletta, Cassini, Grazia Maria Attinà, Claudio, Arcudi, Bruno, Sensi, Roberto, Campagnacci, Angela, Maurizi, Massimo, Basti, Diletta, Frazzini, Valerio, Caracino, Corrado, Pedrazzani, Giulia, Turri, Stefano, Mancini, Andrea, Sagnotta, Marco, Scatizzi, Lorenzo, Pandolfini, Alessandro, Falsetto, Gian Luca Baiocchi, Sarah, Molfino, Mauro, Totis, Marco, Braga, Andrea, Liverani, Tatiana Di Cesare, Stefano, Scabini, Antonio, Martino, Raffaele De Luca, Michele, Simone, Alessandro, Carrara, Giuseppe, Tirone, Michele, Motter, Marco, Caricato, Gabriella Teresa Capolupo, Pietro, Amodio, Raffaele, Macarone, Palmieri, Maurizio, Pavanello, Carlo Di Marco, Andrea, Muratore, Patrizia, Marsanic, Alberto, Patriti, Valerio, Sisti, Andrea, Lucchi, Giacomo, Martorelli, Clementi, Marco, Guadagni, Stefano, Graziano, Longo, Federico, Tomassini, Simone, Santoni, Nereo, Vettoretto, Emanuele, Botteri, Andrea, Armellini, Giuseppe, Brisinda, Maria Michela Chiarello, Maria, Cariati, Stefano, Berti, Andrea, Gennai, Gabriele, Anania, Serena, Rubino, Walter, Siquini, Alessandro, Cardinali, Mariantonietta Di Cosmo, Daniele, Zigiotto, Lucio, Taglietti, Silvia, Ruggiero, Alberto Di Leo, Jacopo, Andreuccetti, Paolo, Millo, Manuela, Grivon, and Diana, Giannarelli.

Subjects
Male, medicine.medical_specialty, Anastomotic Leak, Anastomosis, Logistic regression, NO, Postoperative Complications, Colorectal surgery, Internal medicine, medicine, Anastomotic leakage, Humans, ERAS, Prospective Studies, Prospective cohort study, Univariate analysis, business.industry, Institutionalization, Odds ratio, Length of Stay, Colorectal surgery · ERAS · Major morbidity · Anastomotic leakage, Settore MED/18, Major morbidity, Surgery, Observational study, Morbidity, business, Enhanced Recovery After Surgery, Abdominal surgery
Abstract

Enhanced recovery after surgery (ERAS) programs influence morbidity rates and length of stay after colorectal surgery (CRS), and may also impact major complications and anastomotic leakage rates. A prospective multicenter observational study to investigate the interactions between ERAS program adherence and early outcomes after elective CRS was carried out. Prospective enrolment of patients submitted to elective CRS with anastomosis in 18 months. Adherence to 21 items of ERAS program was measured upon explicit criteria in every case. After univariate analysis, independent predictors of primary endpoints [major morbidity (MM) and anastomotic leakage (AL) rates] were identified through logistic regression analyses including all significant variables, presenting odds ratios (OR). Institutional ERAS protocol was declared by 27 out of 38 (71.0%) participating centers. Median overall adherence to ERAS program items was 71.4%. Among 3830 patients included in the study, MM and AL rates were 4.7% and 4.2%, respectively. MM rates were independently influenced by intra- and/or postoperative blood transfusions (OR 7.79, 95% CI 5.46–11.10; p

Published
2022

13. A New Score to Assess the Perioperative Period of the Cancer Patient Undergoing Non-Palliative Elective Surgery: A Retrospective Evaluation of a Case Report by PERIDIA Score

Author

Gaetano Napoli, Letizia Andresciani, Simona De Summa, Giulia Losito, Anna De Rosa, Maria Ronchi, Grazia Bradascio, Giovanni Mastrandrea, Christel Cariddi, Mariarita Laforgia, Elisabetta Rizzo, Giuseppe Carravetta, Rosa Boccuzzi, Concetta Calabrò, and Michele Simone

Subjects
Cancer Research, medicine.medical_specialty, law.invention, law, Anesthesiology, Medicine, In patient, Elective surgery, peridiaphragmatic surgery, Prospective cohort study, RC254-282, Original Research, business.industry, Incidence (epidemiology), Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Cancer, Perioperative, medicine.disease, Intensive care unit, anesthesiology, Oncology, ICU, Emergency medicine, cancer patients, business, perioperative score
Abstract

The complexity of cancer patients and the use of advanced and demolitive surgical techniques frequently need post-operatory ICU hospitalization. To increase safety and to select the best medical strategies for the patient, a multidisciplinary team has performed a new peri-operatory assessment, arising from evidence-based literature data. Verifying that most of the cancer patients, admitted to the intensive care unit, undergo major surgery with localizations in the supramesocolic thoraco-abdominal area, the team focused the attention on supramesocolic peridiaphragmatic cancer surgery. Some scores already in use in clinical practice were selected for the peri-operatory evaluation process. None of them evaluate parameters relating to the entire peri-operative period. In detail, only a few study models were found that concern the assessment of the intra-operative period. Therefore, we wanted to see if using a mix of validated scores, it was possible to build a single evaluation score (named PERIDIAphragmatic surgery score or PERIDIA-score) for the entire peri-operative period that could be obtained at the end of the patient’s hospitalization period in post-operative ICU. The main property sought with the creation of the PERIDIA-score is the proportionality between the score and the incidence of injuries, deaths, and the length of stay in the ward. This property could organize a tailor-made therapeutic path for the patient based on pre-rehabilitation, physiotherapy, activation of social assistance services, targeted counseling, collaborations with the continuity of care network. Furthermore, if the pre-operative score is particularly high, it could suggest different or less invasive therapeutic options, and if the intra-operative score is particularly high, it could suggest a prolongation of hospitalization in ICU. The retrospective prospective study conducted on 83 patients is still ongoing. The first data would seem to prove an increase of clinical complications in patients who were assigned a one-third score with respect to the maximum (16/48) of PERIDIA-score. Moreover, patients with a 10/16 score within each phase of the evaluation (pre, peri, and post) more frequently develop injuries. In the light of these evidence, the 29-point score assigned to our patient can be considered as predictive for the subsequent critical and fatal complications the patient faced up.

Published
2021

15. Adrenal Schwannomas: Rare Tumor of the Retroperitoneum

Author

Emanuele Grasso and Michele Simone

Subjects
Surgery, RD1-811
Abstract

Schwannoma is a benign neurogenic tumor originating from Schwann cells. These produce the myelin sheath that covers peripheral nerves that are often affected. This latter localization is extremely rare, and only a few case reports can be found in the medical literature. Studies have shown that approximately 0.5% to 5% of schwannomas are retroperitoneal, constituting 0.2% of adrenal incidental tumors. These usually present as incidental findings, nonsecreting adrenal masses in asymptomatic patients. Diagnosis of a schwannoma is based on detection of spindle cells with Antoni A and Antoni B regions in histological sections and positive staining for S-100 protein by immunohistochemical analysis. We report a case of an incidentally identified during an abdominal ultrasound examination with schwannoma localized in the left adrenal gland.

Published
2015
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17. Targeting Angiogenesis in Biliary Tract Cancers: An Open Option

Author

Valeria Simone, Oronzo Brunetti, Luigi Lupo, Mario Testini, Eugenio Maiorano, Michele Simone, Vito Longo, Christian Rolfo, Marc Peeters, Aldo Scarpa, Amalia Azzariti, Antonio Russo, Domenico Ribatti, and Nicola Silvestris

Subjects
biliary tract cancers, angiogenesis, vascular endothelial growth factor, monoclonal antibodies, tyrosine kinase inhibitors, Biology (General), QH301-705.5, Chemistry, QD1-999
Abstract

Biliary tract cancers (BTCs) are characterized by a bad prognosis and the armamentarium of drugs for their treatment is very poor. Although the inflammatory status of biliary tract represents the first step in the cancerogenesis, the microenvironment also plays a key role in the pathogenesis of BTCs, promoting tumor angiogenesis, invasion and metastasis. Several molecules, such as vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF), are involved in the angiogenesis process and their expression on tumor samples has been explored as prognostic marker in both cholangiocarcinoma and gallbladder cancer. Recent studies evaluated the genomic landscape of BTCs and evidenced that aberrations in several genes enrolled in the pro-angiogenic signaling, such as FGF receptor-2 (FGFR-2), are characteristic of BTCs. New drugs targeting the signaling pathways involved in angiogenesis have been tested in preclinical studies both in vitro and in vivo with promising results. Moreover, several clinical studies tested monoclonal antibodies against VEGF and tyrosine kinase inhibitors targeting the VEGF and the MEK/ERK pathways. Herein, we evaluate both the pathogenic mechanisms of BTCs focused on angiogenesis and the preclinical and clinical data available regarding the use of new anti-angiogenic drugs in these malignancies.

Published
2017
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18. A Case of Myxoid Liposarcoma of the Retroperitoneum: A Challenging Tumour for Diagnosis and Treatment

Author

Emanuele Grasso, Fabio Marino, Michele Bottalico, and Michele Simone

Subjects
Surgery, RD1-811
Abstract

Retroperitoneal sarcomas are rare neoplasms that account for only 1%-2% of all solid tumors and liposarcomas represent the most frequent histological type. We describe the case of a 44-year-old female with a retroperitoneal myxoid liposarcoma of 22 × 19 × 8 cm in size. The only symptoms were persistent pain and progressive tenderness of the abdomen lasting for two months. The mass was radically excised during laparotomy. CT and MRI were useful to clarify the site of origin of the tumor, relationships with other organs, and planning surgery but final diagnosis was based on histological findings. Here we review the literature about the challenging diagnosis, treatment, and prognostic factors of this disease.

Published
2014
Full Text
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19. An Intrapancreatic accessory spleen presenting as a neuroendocrine tumor

Author

Carmine, Cartanese, Martino, Minardi, Anna, Crocco, Graziana, Barile, Raffaele, De Luca, Rocco, Lomonaco, Antonello, Rucci, Eustachio, Ruggieri, and Michele, Simone

Subjects
Diagnosis, Differential, Pancreatic Neoplasms, Neuroendocrine Tumors, Humans, Pancreatic Diseases, Female, Choristoma, Middle Aged, Tomography, X-Ray Computed, Spleen
Abstract

Although the second most common site of the accessory spleen is the tail of the pancreas, intrapancreatic accessory spleens (IPAS) are rarely recognized radiologically. When an accessory spleen is located in the pancreas, it may mimic a hypervascular pancreatic tumor. We report a case of intrapancreatic accessory spleen which radiologically (on TC) mimicked a neuroendocrine pancreatic tumor (PNET). It was not possible to be sure that the pancreatic nodule had no malignant potential; because of the close proximity to splenic vessel we performed en bloc resection of the spleen and distal pancreas. Postoperative course was uneventful. IPAS must be considered in the differential diagnosis of pancreatic tail tumors, particulary an asymptomatic small PNET; new and adequate diagnostic studies have demonstrated utility in defining these lesions. We review pertinent literature. KEY WORD: Intrapancreatic accessory spleen, Pancreatic neuroendocrine tumor.Sebbene il secondo sito più comune della milza accessoria sia la coda del pancreas, la milza accessoria intrapancreatica è raramente riconosciuta radiologicamente. Quando una milza accessoria si trova nel pancreas, può simulare un tumore pancreatico ipervascolare; riportiamo un caso che alla TC era diagnosticato come un tumore pancreatico neuroendocrino. Non potendo escludere la potenzialità maligna del nodulo pancreatico, è stata eseguita una spleno-pancreasectomia distale. Il decorso postoperatorio è stato regolare. La milza accessoria intrapancreatica deve essere considerata nella diagnosi differenziale dei tumori della coda del pancreas, in particolare un piccolo tumore neuroendocrino asintomatico; nuovi e adeguati mezzi diagnostici hanno dimostrato utilità nel definire queste lesioni; esaminiamo la letteratura pertinente.

Published
2020

20. Global variation in the long-term outcomes of ypT0 rectal cancers

Author

Laura Lorenzon, Serge Evrard, Geerard Beets, Santiago Gonzalez-Moreno, Tibor Kovacs, Domenico D’Ugo, Karol Polom, Irene Terrenato, Rajesh S. Shinde, Avanish Saklani, Pedro Martins, José Flávio Videira, Eduard-Alexandru Bonci, Patriciu Achimas-Cadariu, Franco Marinello, Eloy Espin, Sofia Xenaki, Konstantinos Lasithiotakis, Daniela Rega, Paolo Delrio, László Andrási, György Lázár, Roberto Quattromani, Ugo Elmore, Martina Azzurra Branciforte, Diego Piazza, Tamás Sztipits, Tamás Mersich, Vincenzo Vigorita, Alberto San Ildefonso, Desiree Cianflocca, Maria Carmela Giuffrida, Alberto Biondi, Roberto Persiani, Jurij Aleš Košir, Jan Grosek, Gianluca Rizzo, Claudio Coco, Egle Dieninyte-Misiune, Rimantas Bausys, Augustinas Bausys, Tomas Poskus, Aurélien Dupré, Mihai-Stefan Muresan, Călin Ionescu, Mohammad Alyami, Eddy Cotte, Francesca Di Candido, Antonino Spinelli, Alessio Lucarini, Genoveffa Balducci, Michał Kisielewski, Michał Pędziwiatr, Hidde Kroon, Tarik Sammour, Lukas Unger, Anton Stift, Patrizia Marsanic, Andrea Muratore, Mustafa Yener Uzunoglu, Fatih Altintoprak, Michela Giulii Capponi, Elia Poiasina, Andreas Brandl, Felix Aigner, David Aparício, Carlos Leichsenring, Pio Corleone, Nicolò de Manzini, Paweł Kabata, Maciej Świerblewski, Gaetano Gallo, Mario Trompetto, Ionut Negoi, Mircea Beuran, Ahmad Souriti, Gregory Taylor, Raffaele De Luca, Michele Simone, Matthew Bedford, Vasileios Charalampakis, Shiv Rajan, Arun Chaturvedi, Marco Veltri, Dario Parini, Luca Turati, Giovanni Sgroi, Matei Bratu, Bogdan Diaconescu, Mihail Slavchev, Nikolay Belev, Mariana Matzner Perfumo, Nicolas Rotholtz, Justyna Wajda, Wojciech Wysocki, Carmen Cagigas Fernandez, Marcos Gomez Ruiz, Serafino Marino, Giuseppe Resta, Tsvetomir Ivanov, Dobromir Dimitrov, Claudia Kaufmann, Reinhold Kafka-Ritsch, Omer Yalkin, Ali Ekrem Ünal, Giovanni Augusto Loche, Nicola Cillara, Francesco Colombo, Diego Foschi, Sara Pollesel, Franco Roviello, Mihail Slavchev, Alessio Lucarini, Avanish Saklani, Mustafa Yener Uzunoglu, Giuffrida, Maria Carmela, Hidde M Kroon, Gaetano Gallo, Dupre, Aurelien, Laura Lorenzon, Francesca Di Candido, Eduard-Alexandru Bonci, Karol Polom, Geerard Beets, Dobromir Dimitrov, Vincenzo VV Vigorita, De Luca, Raffaele, Mihai-Stefan Muresan, Ionuț Bogdan Diaconescu, Lorenzon, Laura, Evrard, Serge, Beets, Geerard, Gonzalez-Moreno, Santiago, Kovacs, Tibor, D'Ugo, Domenico, Polom, Karol, and de Manzini, Nicolo'

Subjects
Male, Oncology, Time Factors, Complete tumor response, Colorectal cancer, Settore MED/18 - CHIRURGIA GENERALE, medicine.medical_treatment, 030230 surgery, 0302 clinical medicine, Neoadjuvant treatment, Long term outcomes, complete pathological response, Rectal cancer, Colectomy, General Medicine, Middle Aged, early stage, Total mesorectal excision, colorectal cancer, neoadjuvant treatment, Treatment Outcome, Lymphatic Metastasis, 030220 oncology & carcinogenesis, ypT0, Female, Cohort study, Adult, Local excision, medicine.medical_specialty, Organ preservation, 03 medical and health sciences, Internal medicine, medicine, Humans, Neoplasm Staging, Retrospective Studies, Rectal Neoplasms, business.industry, Retrospective cohort study, Chemoradiotherapy, Adjuvant, medicine.disease, Radiation therapy, Propensity score matching, Surgery, business, Follow-Up Studies
Abstract

Background: Colorectal cancer mortality presents world-wide variation. In rectal cancers presenting a complete/nearly-complete tumor response (ypT0/ypTis) following neoadjuvant treatment, the features correlated to nodal metastases and relapses still need to be defined. Methods: An international cohort study enrolling ypT0/ypTis rectal cancers surgically treated from 2012 to 2017 was conducted. A propensity matching was used to balance nodal-positive and nodal-negative patients and statistical analyses were performed to investigate survivals, using a bootstrap model for internal validation. The features correlated with nodal metastasis were studied. Countries with partici- pating centers were ranked using the World Bank (WBI), Human Development (HDI) and Global Gender Gap (GGG) indexes to compare survivals. Results: 680 ypT0/ypTis from 52 European, Australian, Indian and American Institutions were analyzed. Mean follow-up was of 30.4 months. 96.5% were treated with total mesorectal excision, 7.2% were nodal- positive and 8.8% relapsed. Distal cancers (HR 0.71 95%CI: 0.56-0.91) and nodal metastasis and nodal metastasis (HR 3.85 95%CI:1.12e13.19) correlated with worse DFS, whereas a younger age was of borderline significance (HR 0.95 95%CI:0.91e0.99). The bootstrap analysis validated the model on 5000 repetitions. A short-course radiotherapy (OR 0.18 95%CI:0.09e0.37) correlated with the occurrence of nodal metastasis. Those countries classified in the low/medium-WBI, medium-HDI and lower-GGG ranks documented worse DFS curves (respectively p < 0.0001, p < 0.0001 and p 0.0002). However, the clinical stages were similar and patients from medium-HDI countries received more adjuvant chemotherapy than the others (p < 0.0001). Conclusion: Sub-groups at risk for relapses and nodal metastasis were identified. A global variation exists also when benchmarking a rectal cancer complete regression.

Published
2020

22. Targeting Angiogenesis in Biliary Tract Cancers: An Open Option

Author

Christian Rolfo, Oronzo Brunetti, Mario Testini, Valeria Simone, Eugenio Maiorano, Amalia Azzariti, Michele Simone, Domenico Ribatti, Vito Longo, Luigi Lupo, Marc Peeters, Aldo Scarpa, Antonio Russo, Nicola Silvestris, Simone, V., Brunetti, O., Lupo, L., Testini, M., Maiorano, E., Simone, M., Longo, V., Rolfo, C., Peeters, M., Scarpa, A., Azzariti, A., Russo, A., Ribatti, D., and Silvestris, N.

Subjects
0301 basic medicine, MAPK/ERK pathway, Vascular Endothelial Growth Factor A, Angiogenesis, Drug Evaluation, Preclinical, Tyrosine kinase inhibitor, Angiogenesis Inhibitors, Review, Fibroblast growth factor, Catalysi, Metastasis, Antineoplastic Agent, lcsh:Chemistry, chemistry.chemical_compound, angiogenesis, 0302 clinical medicine, tyrosine kinase inhibitors, Molecular Targeted Therapy, lcsh:QH301-705.5, Spectroscopy, Clinical Trials as Topic, Monoclonal antibodie, Neovascularization, Pathologic, vascular endothelial growth factor, Computer Science Applications1707 Computer Vision and Pattern Recognition, General Medicine, Computer Science Applications, Vascular endothelial growth factor, Gene Expression Regulation, Neoplastic, Angiogenesi, Chemistry, Biliary Tract Neoplasms, Treatment Outcome, Biliary Tract Neoplasm, 030220 oncology & carcinogenesis, monoclonal antibodies, Tyrosine kinase, Angiogenesis Inhibitor, Human, Signal Transduction, Protein Kinase Inhibitor, Antineoplastic Agents, biliary tract cancers, Biology, Models, Biological, Biliary tract cancers, Monoclonal antibodies, Tyrosine kinase inhibitors, Animals, Genetic Variation, Humans, Protein Kinase Inhibitors, Catalysis, Molecular Biology, Physical and Theoretical Chemistry, Organic Chemistry, Inorganic Chemistry, 03 medical and health sciences, In vivo, medicine, Gallbladder cancer, Animal, medicine.disease, 030104 developmental biology, chemistry, lcsh:Biology (General), lcsh:QD1-999, Immunology, Cancer research, Biliary tract cancer
Abstract

Biliary tract cancers (BTCs) are characterized by a bad prognosis and the armamentarium of drugs for their treatment is very poor. Although the inflammatory status of biliary tract represents the first step in the cancerogenesis, the microenvironment also plays a key role in the pathogenesis of BTCs, promoting tumor angiogenesis, invasion and metastasis. Several molecules, such as vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF), are involved in the angiogenesis process and their expression on tumor samples has been explored as prognostic marker in both cholangiocarcinoma and gallbladder cancer. Recent studies evaluated the genomic landscape of BTCs and evidenced that aberrations in several genes enrolled in the pro-angiogenic signaling, such as FGF receptor-2 (FGFR-2), are characteristic of BTCs. New drugs targeting the signaling pathways involved in angiogenesis have been tested in preclinical studies both in vitro and in vivo with promising results. Moreover, several clinical studies tested monoclonal antibodies against VEGF and tyrosine kinase inhibitors targeting the VEGF and the MEK/ERK pathways. Herein, we evaluate both the pathogenic mechanisms of BTCs focused on angiogenesis and the preclinical and clinical data available regarding the use of new anti-angiogenic drugs in these malignancies.

Published
2017

23. Largest Reported Series of Adults Who Received Treatment with Eculizumab (ECU) for Hematopoietic Cell Transplantation-Associated Thrombotic Microangiopathy (TA-TMA). a Single Center Experience

Author

Maribel Pereiras, Scott D. Rowley, Alan P Skarbnik, Michele Simone, Andrew L. Pecora, Mary E Dilorenzo, Michele L. Donato, Tracy Andrews, and David H. Vesole

Subjects
Meningitides, medicine.medical_specialty, Thrombotic microangiopathy, business.industry, medicine.medical_treatment, Immunology, Cell Biology, Hematology, Hematopoietic stem cell transplantation, Eculizumab, Single Center, medicine.disease, Biochemistry, Transplantation, hemic and lymphatic diseases, Internal medicine, Atypical hemolytic uremic syndrome, medicine, Prospective cohort study, business, medicine.drug
Abstract

Background: TA-TMA is a life-threatening complication of hematopoietic cell transplantation (HCT), usually manifested as a combination of non-immune mediated hemolytic anemia, thrombocytopenia and end-organ dysfunction (renal, neurologic and/or hypertension). Reported mortality rates following TA-TMA are high (50-75%; Gavriilaki et al, Bone Marrow Transplantation 2017). It is more commonly associated with allogeneic HCT, however, may infrequently occur with autologous HCT. Traditionally, treatment for TA-TMA consisted in removing possible offending agents (calcineurin inhibitors, sirolimus) and/or instituting total plasma exchange (PLEX). These approaches have not resulted in significant improvement in the natural history of TA-TMA, with complete resolution in 12-20% of pts (Mulay et al, J Clin Apher 2015). Recent evidence of alternate complement pathway activation has been implicated in the pathophysiology of TA-TMA (Jodele et al, Blood 2013). Eculizumab (ECU) is an anti-C5 monoclonal antibody, approved for treatment of PNH and aHUS, which has been used anecdotally as treatment for TA-TMA. Most reports consist of pediatric patients. In this analysis, we evaluated consecutive cases of adult recipients of HCT who developed TA-TMA and have received ECU therapy at our institution. Methods: We reviewed electronic records of consecutive patients who presented with a diagnosis of TA-TMA (non-immune hemolytic anemia plus worsening thrombocytopenia and end-organ dysfunction) and were treated with ECU between 2015 and 2017 at our institution. Univariate and bivariate statistics were calculated for the sample; Fisher's exact tests and Wilcoxon rank sum tests were utilized to test for differences across groups. Results: Table 1 shows the baseline characteristics of these pts. A total of 15 pts were included in the analysis; 2/3 were female and the median age was 62. ECU was given according to the usual schedule for aHUS (900 mg IV weekly x 4, 1200 mg every other week starting on week 5). Median time from TA-TMA diagnosis to initiation of ECU was 2 days. All patients received prophylaxis for Neisseria meningitides with ciprofloxacin and antifungal prophylaxis at initiation of ECU. Three (20%) pts received PLEX prior to ECU. Seven (47%) patients were receiving tacrolimus at diagnosis, however, levels were not within toxic range (3.7-7.9 ng/mL). Median time post-HCT for development of TA-TMA was 135 days. Median LDH, hemoglobin, platelet count and creatinine at TA-TMA diagnosis were 1724 U/L, 7.3 g/dL, 33,000/mcL and 1.7 mg/dL, respectively. Ten (66.6%) patients had acute kidney injury and 7 (46.6%) pts had neurologic manifestations. Eight (53.3%) pts had evidence of GVHD concurrent with TA-TMA diagnosis. Ten (63.3%) pts developed systemic infections during their TA-TMA treatment. No pts developed meningitis or fungal infections. Median follow-up was 4.5 months after initiation of ECU. Eight (53.3%) patients had complete resolution of TA-TMA (i.e. resolution of hemolytic anemia, thrombocytopenia and end-organ damage), 4 of these 8 pts were recipients of autologous HCT. Median time to resolution was 98 days and median cumulative ECU dose was 10,200 mg (range 4800-36400mg). An additional 2 pts (13%) presented clinical improvement without complete resolution of TA-TMA. Mortality secondary to TA-TMA or its complications was 33%. Median time to death was 31 days. The most common cause of mortality were infectious complications. Median survival for the entire cohort was 130 days (range 6-833 days, Figure). LDH >1300 U/L; more than one organ involvement, allogeneic HCT, use of tacrolimus and early ( Conclusion: To our knowledge, this is the largest reported series of adult pts with TA-TMA who were treated with ECU. Treatment with ECU for TA-TMA is associated with higher rates of resolution and lower rates of cause-specific mortality than what has been previously reported with other approaches. We hypothesize that higher cumulative doses of ECU are warranted to achieve resolution of TA-TMA. A prospective study utilizing a more intensive schedule of ECU infusions is required to confirm such hypothesis. Based on our analysis, we conclude that ECU is an appropriate - and potentially better - option in the treatment of TA-TMA. Disclosures Skarbnik: Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Jazz Pharmaceuticals: Honoraria, Speakers Bureau; Genentech: Honoraria, Speakers Bureau; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pharmacyclics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Gilead Sciences: Honoraria, Speakers Bureau.

Published
2018

24. Syndesmosis injuries of the ankle

Author

Antonietta Florio, Michele Simone Boccanera, Nicola Maffulli, and Angelo Del Buono

Subjects
medicine.medical_specialty, Syndesmosis, Rehabilitation, medicine.diagnostic_test, Sports medicine, business.industry, medicine.medical_treatment, Arthroscopy, medicine.disease, Ice hockey, medicine.anatomical_structure, Orthopedic surgery, medicine, Physical therapy, Diastasis, Orthopedics and Sports Medicine, Ankle, business, human activities, Foot and Ankle (SG Parekh, Section Editor)
Abstract

Ankle syndesmosis injuries are relatively frequent in sports, especially skiing, ice hockey, and soccer, accounting for 1 %-18 % of all ankle sprains. The evolution is unpredictable: When missed, repeated episodes of ankle instability may predispose to early degenerative changes, and frank osteoarthritis may ensue. Diagnosis is clinical and radiological, but arthroscopy may provide a definitive response, allowing one to address secondary injuries to bone and cartilage. Obvious diastasis needs to be reduced and fixed operatively, whereas less severe injuries are controversial. Nonoperative treatment may be beneficial, but it entails long rehabilitation. In professional athletes, more aggressive surgical treatment is warranted.

Published
2013

25. A case of myxoid liposarcoma of the retroperitoneum: a challenging tumour for diagnosis and treatment

Author

Michele Bottalico, Emanuele Grasso, Fabio Marino, and Michele Simone

Subjects
Myxoid liposarcoma, Pathology, medicine.medical_specialty, Retroperitoneal sarcomas, Histological type, business.industry, Persistent pain, medicine.medical_treatment, lcsh:Surgery, Case Report, lcsh:RD1-811, Disease, medicine.disease, Surgery, medicine.anatomical_structure, Laparotomy, medicine, Abdomen, Pharmacology (medical), business, Site of origin
Abstract

Retroperitoneal sarcomas are rare neoplasms that account for only 1%-2% of all solid tumors and liposarcomas represent the most frequent histological type. We describe the case of a 44-year-old female with a retroperitoneal myxoid liposarcoma of 22 × 19 × 8 cm in size. The only symptoms were persistent pain and progressive tenderness of the abdomen lasting for two months. The mass was radically excised during laparotomy. CT and MRI were useful to clarify the site of origin of the tumor, relationships with other organs, and planning surgery but final diagnosis was based on histological findings. Here we review the literature about the challenging diagnosis, treatment, and prognostic factors of this disease.

Published
2014

26. Treatment of Hemorrhoids with Circular Stapler, A New Alternative To Conventional Methods: A Prospective Study of 140 Patients

Author

Michele Simone, Noel Huten, Nicolò de Manzini, Berangere Laurent, Jean Jacques Tuech, Patrick Pessaux, Jean Pierre Arnaud, Arnaud, Jp, Pessaux, P, Huten, N, de Manzini, Nicolo', Tuech, Jj, Laurent, B, and Simone, M.

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Analgesic, emorroidi, stapler, Hemorrhoids, Wound care, Surgical Staplers, medicine, Humans, Prospective Studies, Prospective cohort study, Digestive System Surgical Procedures, Aged, Pain Measurement, Randomized Controlled Trials as Topic, Aged, 80 and over, Pain, Postoperative, Vascular disease, business.industry, Postoperative complication, Equipment Design, Perioperative, Length of Stay, Middle Aged, medicine.disease, Surgery, Treatment Outcome, Patient Satisfaction, Female, Complication, business
Abstract

Background: Surgical hemorrhoidectomy has a reputation for being a painful procedure. The aim of this study was to determine the efficacy and safety of a new procedure for surgical treatment of hemorrhoid disease. Study Design: From April 1998 to August 1998, 140 patients (83 men and 57 women) with an average age of 43.8 years (range 19 to 83 years) underwent hemorrhoidectomy using a circular stapler. Operative times, peri- and postoperative complications, mean hospital stay, assessment of the postoperative pain, period of incapacity for work, and functional results were collected. All patients were evaluated at 2 weeks, 2 months, and 18 months after operation. Results: The average length of the operation was 18 minutes (range 8 to 60 minutes). There were no perioperative complications. The postoperative complication rate was 6.4% (n = 9). Mean hospital stay was 36 hours (range 8 to 72 hours). Paracetamol was the only analgesic used. Eighty-three patients (59.3%) required analgesic for less than 2 days, 45 patients (32.1%) between 2 and 7 days, and 12 patients (8.6%) more than 7 days. No patients had anal wound care. One hundred four patients had professions. The period of incapacity for work was less than 3 days for 22 patients (21.1%), between 3 and 7 days for 13 patients (12.5%), between 7 and 14 days for 62 patients (59.6%), and more than 14 days for 7 patients (6.8%). At 18 months, 95.7% of patients were fully satisfied with the results, 3.6% were somewhat satisfied (n = 4), and 0.7% were unsatisfied. Conclusions: Treatment of hemorrhoids with a circular stapler appears to be safe, effective, and rapid, causing few postoperative complications and minimal postoperative pain. At 18 months, 95.7% of the patients were fully satisfied with the results.

Published
2001

27. Three-Dimensional Virtual Cholangioscopy: A Reliable Tool for the Diagnosis of Common Bile Duct Stones.

Author

Michele Simone

Subjects
CHOLANGIOSCOPY, ENDOSCOPY, ELECTRONIC systems, DIAGNOSIS
Abstract

OBJECTIVE:: Our goal was to evaluate the clinical reliability of a new software system employing 3-dimensional (3D) virtual anatomic reconstruction and intraluminal virtual exploration for detection of choledocholithiasis and preoperative visualization of the biliary anatomy. SUMMARY BACKGROUND DATA:: Virtual reality systems have been proposed for gastroscopy, bronchoscopy, and colonoscopy, as well as for the 3D reconstruction of liver anatomy and hepatic lesions. The impact of these systems in preoperative diagnostics has not been established due to the lack of large clinical series evaluating their reliability. METHODS:: From November 2000 to July 2002, all patients presenting to our Institute with suspected choledocholithiasis were prospectively included in the study. All patients underwent conventional magnetic resonance cholangiopancreatography (MRCP) and either intraoperative cholangiogram (IOC) or endoscopic retrograde cholangiopancreatography (ERCP). The digital data from MRCP were incorporated into an original virtual reality software system to generate a 3D reconstruction. All 3D reconstructions were evaluated by a surgeon and a computer software engineer who were blind to the results of the IOC or ERCP. Sensitivity and specificity were then calculated based on the results of either the IOC or ERCP. RESULTS:: Sixty-five patients were enrolled in the study. The average time required to reconstruct the images into navigable virtual reality was 7.5 minutes (range, 4'''13.5). The 3D virtual cholangioscopy had sensitivity and specificity rates of 71% and 91%, respectively, compared with 61% and 86% of the standard MRCP. CONCLUSION:: The 3D virtual cholangioscopy provides detailed preoperative reconstruction of biliary anatomy and reliable identification of choledocholithiasis with acceptable sensitivity and specificity in a clinical setting. Newer software developments may further enhance its accuracy, so that virtual cholangioscopy might challenge or replace more invasive diagnostic measures in the near future. [ABSTRACT FROM AUTHOR]

Published
2004
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28. Synchronous and subharmonic resonance of an array of curved wave energy converters in a channel.

Author

Michele, Simone and Renzi, Emiliano

Subjects
*WAVE energy, *RESONANCE, *OCEAN wave power, *DYNAMICAL systems, *EVOLUTION equations, *NONLINEAR difference equations, *DEVIATION (Statistics)
Abstract

We analyse the nonlinear behaviour of an array of curved surge-type wave energy converters(WECs) in a semi-infinite channel of constant depth. Surge-type WECs have attractedinterests by researchers and industry, mainly because of their capability to absorb energy withpotentially large efficiency when excited by incident waves. The vast majority of the theoretical models developed so far on the dynamics of this kindof devices neglect nonlinear contributions. This can be unjustified when nonlinearresonances of trapped modes occur. Indeed, Michele et al. (2018b) recently showed thatsubharmonic resonance and mode competition of trapped modes can increase energyproduction of a system of surging WECs. Moreover, recent investigations on curvedflap-type gates suggest that using curved structures could further improve wave energyextraction efficiency. Motivated by these new aspects, in this work we investigate theeffect of gate surface curvature on the nonlinear dynamics of an array of surge-typeWECs. We show that a small horizontal deviation of the gate surface produces significantchanges in the dynamical behaviour of the system. Using perturbation-harmonic expansionup to the third order, we decompose the nonlinear governing equations in a sequence oflinearised boundary-value problems of order n and harmonic m. The gate shape effectsresonate the first harmonic at the second order, so that three timing with two slow time scalesis necessary. First, we consider the synchronous excitation of a single trapped mode. Products betweenthe gate shape function and the second-order terms force the first harmonic at the third order.We point out that this particular excitation is not possible for flat gates, because in that casethe corresponding evolution equation would be damped and unforced. We also show theoccurrence of new terms in the Ginzburg-Landau evolution equation, which are notpresent in the case of flat gates. We show that nonlinear synchronous resonance ofcurved WECs yields constructive interactions that can be significant for designpurposes. Finally, we analyse the occurrence of subharmonic nonlinear resonance bymonochromatic incident waves. Perturbation expansion of the unknowns leads to anevolution equation similar to that obtained for the synchronous case. Then we define anoptimized PTO coefficient which maximises power extraction under subharmonic resonance.The capture factor reaches much larger values than the theoretical maximum of aWEC in a channel described by the linearised theory. Furthermore, we show thatsubharmonic resonance is associated with increased efficiency of wave power extraction,though the effects of curvature are not always beneficial as we initially thought. [ABSTRACT FROM AUTHOR]

Published
2019

29. Segmental transverse colectomy. Minimally invasive versus open approach: results from a multicenter collaborative study

Author

Milone, M., Degiuli, M., Velotti, N., Manigrasso, M., Vertaldi, S., D'Ugo, D., De Palma, G. D., Bruzzese, D., Servillo, G., De Simone, G., Di Lauro, K., Pavanello, Sofia, Ettore Allaix, M., Morino, M., Reddavid, R., Rega, D., Alberto Ammirati, C., Scabini, S., Anania, G., Barberis, A., Longhin, R., Belli, A., Bianco, F., Formisano, G., Giuliani, G., Pietro Bianchi, P., Cavaliere, D., Solaini, L., Coco, C., Rizzo, G., Coratti, A., Tribuzi, A., De Luca, R., Simone, M., Di Leo, A., De Manzoni, G., De Nardi, P., Elmore, U., Rosati, R., Vignali, A., Delrio, P., Pace, U., Di Cataldo, A., Li Destri, G., Donini, A., Graziosi, L., Fontana, A., Mineccia, M., Gentilli, S., Monni, M., Guerrieri, M., Ortenzi, M., Pecchini, F., Piccoli, M., Pedrazzani, C., Turri, G., Pollesel, S., Roviello, F., Rigamonti, M., Zuolo, M., Santarelli, M., Saraceno, F., Sileri, P., Sigismondo Sica, G., Siragusa, L., Pucciarelli, S., Zuin, M., Bombardini, C., Milone, Marco, Degiuli, Maurizio, Velotti, Nunzio, Manigrasso, Michele, Vertaldi, Sara, D'Ugo, Domenico, De Palma, Giovanni Domenico, Dario Bruzzese, Giuseppe Servillo, Giuseppe De Simone, Katia Di Lauro, Silvia Sofia, Marco Ettore Allaix, Mario Morino, Rossella Reddavid, Carlo Alberto Ammirati, Stefano Scabini, Gabriele Anania, Cristina Bombardini, Andrea Barberis, Roberta Longhin, Andrea Belli, Francesco Bianco, Giampaolo Formisano, Giuseppe Giuliani, Paolo Pietro Bianchi, Davide Cavaliere, Leonardo Solaini, Claudio Coco, Gianluca Rizzo, Andrea Coratti, Raffaele De Luca, Michele Simone, Alberto Di Leo, Giovanni De Manzoni, Paola De Nardi, Ugo Elmore, Riccardo Rosati, Andrea Vignali, Paolo Delrio, Ugo Pace, Daniela Rega, Antonio Di Cataldo, Giovanni Li Destri, Annibale Donini, Luigina Graziosi, Andrea Fontana, Michela Mineccia, Sergio Gentilli, Manuela Monni, Mario Guerrieri, Monica Ortenzi, Francesca Pecchini, Micaela Piccoli, Italy. Corrado Pedrazzani, Giulia Turri, Sara Pollesel, Franco Roviello, Marco Rigamonti, Michele Zuolo, Mauro Santarelli, Federica Saraceno, Pierpaolo Sileri Giuseppe Sigismondo Sica, Luigi Siragusa Salvatore Pucciarelli, Matteo Zuin, and Rosati, Riccardo

Subjects
medicine.medical_specialty, Ileus, Nausea, Anemia, Operative Time, Anastomosis, Postoperative Complications, Laparoscopic, Robotic Surgical Procedures, Minimally invasive surgery, Tumor stage, medicine, Transverse Colectomy, Humans, Robotic surgery, Colectomy, Retrospective Studies, Robotic, Transverse colon cancer, Length of Stay, Treatment Outcome, Colonic Neoplasms, Laparoscopy, business.industry, medicine.disease, Surgery, Settore MED/18, medicine.symptom, business
Abstract

The role of minimally invasive surgery in the treatment of transverse colon cancer is still controversial. The aim of this study is to investigate the advantages of a totally laparoscopic technique comparing open versus laparoscopic/robotic approach. Three hundred and eighty-eight patients with transverse colon cancer, treated with a segmental colon resection, were retrospectively analyzed. Demographic data, tumor stage, operative time, intraoperative complications, number of harvested lymph nodes and recovery outcomes were recorded. Recurrences and death were also evaluated during the follow-up. No differences were found between conventional and minimally invasive surgery, both for oncological long-term outcomes (recurrence rate p = 0.28; mortality p = 0.62) and postoperative complications (overall rate p = 0.43; anemia p = 0.78; nausea p = 0.68; infections p = 0.91; bleeding p = 0.62; anastomotic leak p = 0.55; ileus p = 0.75). Nevertheless, recovery outcomes showed statistically significant differences in favor of minimally invasive surgery in terms of time to first flatus (p = 0.001), tolerance to solid diet (p = 0.017), time to first mobilization (p = 0.001) and hospital stay (p = 0.004). Compared with laparoscopic approach, robotic surgery showed significantly better results for time to first flatus (p = 0.001), to first mobilization (p = 0.005) and tolerance to solid diet (p = 0.001). Finally, anastomosis evaluation confirmed the superiority of intracorporeal approach which showed significantly better results for time to first flatus (p = 0.001), to first mobilization (p = 0.003) and tolerance to solid diet (p = 0.001); moreover, we recorded a statistical difference in favor of intracorporeal approach for infection rate (p = 0.04), bleeding (p = 0.001) and anastomotic leak (p = 0.03). Minimally invasive approach is safe and effective as the conventional open surgery, with comparable oncological results but not negligible advantages in terms of recovery outcomes. Moreover, we demonstrated that robotic approach may be considered a valid option and an intracorporeal anastomosis should always be preferred.

Published
2022

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