Maurizio Degiuli1,2, Monica Ortenzi3, Mariano Tomatis4, Lucia Puca5, Desiree Cianflocca6,7, Daniela Rega8, Annalisa Maroli9, Ugo Elmore10, Francesca Pecchini11, Marco Milone12, Roberta La Mendola13, Erica Soligo14, Simona Deidda15, Domenico Spoletini16, Diletta Cassini17, Alessandra Aprile18, Michela Mineccia19, Herald Nikaj20, Francesco Marchegiani21, Fabio Maiello22, Cristina Bombardini23, Michele Zuolo24, Michele Carlucci25, Luca Ferraro26, Armando Falato27, Alberto Biondi28, Roberto Persiani28, Patrizia Marsanich29, Daniele Fusario30, Leonardo Solaini31, Sara Pollesel32, Gianluca Rizzo32, Claudio Coco32, Alberto Di Leo33, Davide Cavaliere34, Franco Roviello32, Andrea Muratore29, Domenico D'Ugo28, Francesco Bianco27, Paolo Pietro Bianchi26,35, Paola De Nardi26, Marco Rigamonti24, Gabriele Anania23, Claudio Belluco34, Roberto Polastri22, Salvatore Pucciarelli21, Sergio Gentilli20, Alessandro Ferrero19, Stefano Scabini18, Gianandrea Baldazzi17, Massimo Carlini36, Angelo Restivo15, Silvio Testa14, Dario Parini13, Giovanni Domenico De Palma12, Micaela Piccoli11, Riccardo Rosati10, Antonino Spinelli37,38, Paolo Delrio8, Felice Borghi6,39, Marco Guerrieri3, Rossella Reddavid5. 1. University of Turin, Department of Oncology, San Luigi University Hospital, Div of Surgical Oncology, Orbassano, Turin, Italy. maurizio.degiuli@unito.it. 2. Department of Oncology, Head Surgical Oncology and Digestive Surgery, University of Torino, San Luigi University Hospital, Regione Gonzole 10 Orbassano, 10043, Turin, Italy. maurizio.degiuli@unito.it. 3. Clinica Chirurgica Universita' Politecnica delle Marche, Ospedali Riuniti, Ancona, Italy. 4. BSIT, Department of Oncology, University of Turin, Orbassano, Turin, Italy. 5. University of Turin, Department of Oncology, San Luigi University Hospital, Div of Surgical Oncology, Orbassano, Turin, Italy. 6. Department of Surgery, S. Croce e Carle Hospital, Cuneo, Italy. 7. Department of General and Emergency Surgery, Azienda Ospedaliero Universitaria, Città della Salute e della Scienza, Turin, Italy. 8. Colorectal Surgical Oncology, Abdominal Oncology Department, Fondazione Giovanni Pascale IRCCS, Naples, Italy. 9. Colon and Rectal Surgery Division, Humanitas Clinical and Research Center, Via Alessandro Manzoni, 56, Rozzano, 20089, Milan, Italy. 10. Division of Gastrointestinal Surgery, Vita Salute University, San Raffaele Hospital, 20132, Milan, Italy. 11. Unita' Operativa di chirurgia generale, d'urgenza e nuove tecnologie, OCSAE, Azienda Ospedaliero Universitaria di Modena, Modena, Italy. 12. Department of Clinical Medicine and Surgery, Department of Gastroenterology, Endocrinology and Endoscopic Surgery, University of Naples "Federico II", Naples, Italy. 13. General Surgery Unit, Santa Maria della Misericordia Hospital, Rovigo, Italy. 14. S.C. Chirurgia Generale, Ospedale S. Andrea, Vercelli, Italy. 15. Chirurgia Coloproctologica-AOU Cagliari, Dipartimento di Scienze Chirurgiche, Università di Cagliari, Cagliari, Italy. 16. UOC Chirurgia Generale, Ospedale S. Eugenio, Piazzale dell'Umanesimo, 10, 00144, Rome, Italy. 17. Unità Operativa Complessa di Chirurgia Generale, P.O. SSG, ASST NORD MILANO, Milan, Italy. 18. Surgical Oncology Surgery, IRCCS Policlinico San Martino, Genoa, Italy. 19. Department of General and Oncological Surgery, "Umberto I" Mauriziano Hospital, Turin, Italy. 20. SCDU Clinica Chirurgica, General Surgery Department, AOU "Maggiore Della Carità" Hospital, Novara, Italy. 21. Department of Surgical, Oncological, and Gastroenterological Sciences, University of Padua, Padua, Italy. 22. Department of Surgery, General Surgery Unit, Hospital of Biella, Biella, Italy. 23. Department of Surgical Morphology and Experimental Medicine, AOU Ferrara, Ferrara, Italy. 24. General Surgery Division, "Valli del Noce" Hospital, Cles, Provincial Agency for Health Services (APSS), Trento, Italy. 25. Gastrointestinal Surgery, San Raffaele Hospital, 20132, Milan, Italy. 26. Division of General and Robotic Surgery, Dipartimento di Scienze della Salute, Università di Milano, 20142, Milan, Italy. 27. General Surgery Unit, San Leonardo Hospital, ASL-NA3sud, Castellammare di Stabbia, Naples, Italy. 28. Fondazione Policlinico Gemelli, IRCCS, AREA di Chirurgia Addominale, Rome, Italy. 29. Surgical Department, Edoardo Agnelli Hospital, Pinerolo, Italy. 30. UOC General and Oncological Surgery, University of Siena, Siena, Italy. 31. General and Oncologic Surgery, Morgagni-Pierantoni Hospital, Ausl Romagna, Forlì, Italy. 32. Fondazione Policlinico Universitario A. Gemelli, IRCCS, Chirurgia Generale Presidio Columbus, Rome, Italy. 33. UOC di Chirurgia, Ospedale "San Camillo", Trento, Italy. 34. Department of Surgical Oncology, CRO Aviano, National Cancer Institute, IRCCS, Aviano, Italy. 35. Department of Surgery, Misericordia Hospital, Grosseto, Italy. 36. UOC Chirurgia Generale, Ospedale S. Eugenio, Piazzale dell'umanesimo, 10, 00144, Rome, Italy. 37. Humanitas Clinical and Research Center, Via Alessandro Manzoni, 56 Rozzano, 20089, Milan, Italy. 38. Department of Biomedical Science, Humanitas University, Pieve Emanuele, Milan, Italy. 39. Oncological Surgery, Candiolo Cancer Institute-FPO-IRCCS, Candiolo, 10060, Torino, Italy.
Abstract
BACKGROUND: Evidence on the efficacy of minimally invasive (MI) segmental resection of splenic flexure cancer (SFC) is not available, mostly due to the rarity of this tumor. This study aimed to determine the survival outcomes of MI and open treatment, and to investigate whether MI is noninferior to open procedure regarding short-term outcomes. METHODS: This nationwide retrospective cohort study included all consecutive SFC segmental resections performed in 30 referral centers between 2006 and 2016. The primary endpoint assessing efficacy was the overall survival (OS). The secondary endpoints included cancer-specific mortality (CSM), recurrence rate (RR), short-term clinical outcomes (a composite of Clavien-Dindo > 2 complications and 30-day mortality), and pathological outcomes (a composite of lymph nodes removed ≧12, and proximal and distal free resection margins length ≧ 5 cm). For these composites, a 6% noninferiority margin was chosen based on clinical relevance estimate. RESULTS: A total of 606 patients underwent either an open (208, 34.3%) or a MI (398, 65.7%) SFC segmental resection. At univariable analysis, OS and CSM were improved in the MI group (log-rank test p = 0.004 and Gray's tests p = 0.004, respectively), while recurrences were comparable (Gray's tests p = 0.434). Cox multivariable analysis did not support that OS and CSM were better in the MI group (p = 0.109 and p = 0.163, respectively). Successful pathological outcome, observed in 53.2% of open and 58.3% of MI resections, supported noninferiority (difference 5.1%; 1-sided 95%CI - 4.7% to ∞). Successful short-term clinical outcome was documented in 93.3% of Open and 93.0% of MI procedures, and supported noninferiority as well (difference - 0.3%; 1-sided 95%CI - 5.0% to ∞). CONCLUSIONS: Among patients with SFC, the minimally invasive approach met the criterion for noninferiority for postoperative complications and pathological outcomes, and was found to provide results of OS, CSM, and RR comparable to those of open resection.
BACKGROUND: Evidence on the efficacy of minimally invasive (MI) segmental resection of splenic flexure cancer (SFC) is not available, mostly due to the rarity of this tumor. This study aimed to determine the survival outcomes of MI and open treatment, and to investigate whether MI is noninferior to open procedure regarding short-term outcomes. METHODS: This nationwide retrospective cohort study included all consecutive SFC segmental resections performed in 30 referral centers between 2006 and 2016. The primary endpoint assessing efficacy was the overall survival (OS). The secondary endpoints included cancer-specific mortality (CSM), recurrence rate (RR), short-term clinical outcomes (a composite of Clavien-Dindo > 2 complications and 30-day mortality), and pathological outcomes (a composite of lymph nodes removed ≧12, and proximal and distal free resection margins length ≧ 5 cm). For these composites, a 6% noninferiority margin was chosen based on clinical relevance estimate. RESULTS: A total of 606 patients underwent either an open (208, 34.3%) or a MI (398, 65.7%) SFC segmental resection. At univariable analysis, OS and CSM were improved in the MI group (log-rank test p = 0.004 and Gray's tests p = 0.004, respectively), while recurrences were comparable (Gray's tests p = 0.434). Cox multivariable analysis did not support that OS and CSM were better in the MI group (p = 0.109 and p = 0.163, respectively). Successful pathological outcome, observed in 53.2% of open and 58.3% of MI resections, supported noninferiority (difference 5.1%; 1-sided 95%CI - 4.7% to ∞). Successful short-term clinical outcome was documented in 93.3% of Open and 93.0% of MI procedures, and supported noninferiority as well (difference - 0.3%; 1-sided 95%CI - 5.0% to ∞). CONCLUSIONS: Among patients with SFC, the minimally invasive approach met the criterion for noninferiority for postoperative complications and pathological outcomes, and was found to provide results of OS, CSM, and RR comparable to those of open resection.
Authors: T Nakagoe; T Sawa; T Tsuji; M Jibiki; A Nanashima; H Yamaguchi; T Yasutake; H Ayabe; H Ishikawa Journal: J Gastroenterol Date: 2000 Impact factor: 7.527
Authors: Nicola de'Angelis; Elisabeth Hain; Mara Disabato; Cristiana Cordun; Maria Clotilde Carra; Daniel Azoulay; Francesco Brunetti Journal: Int J Colorectal Dis Date: 2015-12-22 Impact factor: 2.571
Authors: Lieve G J Leijssen; Anne M Dinaux; Ramzi Amri; Hiroko Kunitake; Liliana G Bordeianou; David L Berger Journal: World J Surg Date: 2018-10 Impact factor: 3.352
Authors: M Milone; M Degiuli; M E Allaix; C A Ammirati; G Anania; A Barberis; A Belli; P P Bianchi; F Bianco; C Bombardini; M Burati; D Cavaliere; C Coco; A Coratti; R De Luca; G De Manzoni; P De Nardi; M De Rosa; P Delrio; A Di Cataldo; A Di Leo; A Donini; U Elmore; A Fontana; G Gallo; S Gentilli; S Giannessi; G Giuliani; L Graziosi; M Guerrieri; G Li Destri; R Longhin; M Manigrasso; M Mineccia; M Monni; M Morino; M Ortenzi; F Pecchini; C Pedrazzani; M Piccoli; S Pollesel; S Pucciarelli; R Reddavid; D Rega; M Rigamonti; G Rizzo; V Robustelli; F Rondelli; R Rosati; F Roviello; M Santarelli; F Saraceno; S Scabini; G S Sica; P Sileri; M Simone; L Siragusa; S Sofia; L Solaini; A Tribuzi; M Trompetto; G Turri; E D L Urso; S Vertaldi; A Vignali; M Zuin; M Zuolo; D D'Ugo; G D De Palma Journal: Eur J Surg Oncol Date: 2020-03-19 Impact factor: 4.424
Authors: Freddie Bray; Jacques Ferlay; Isabelle Soerjomataram; Rebecca L Siegel; Lindsey A Torre; Ahmedin Jemal Journal: CA Cancer J Clin Date: 2018-09-12 Impact factor: 508.702