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A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial).
Degiuli, Maurizio; Aguilar, Aridai H Resendiz; Solej, Mario; Azzolina, Danila; Marchiori, Giulia; Corcione, Francesco; Bracale, Umberto; Peltrini, Roberto; Di Nuzzo, Maria M; Baldazzi, Gianandrea; Cassini, Diletta; Sica, Giuseppe S; Pirozzi, Brunella; Muratore, Andrea; Calabrò, Marcello; Jovine, Elio; Lombardi, Raffaele; Anania, Gabriele; Chiozza, Matteo; Petz, Wanda; Pizzini, Paolo; Persiani, Roberto; Biondi, Alberto; Reddavid, Rossella.
Afiliação
  • Degiuli M; Division of Surgical Oncology and Digestive Surgery, Department of Oncology, San Luigi University Hospital, University of Turin, Orbassano (Turin), Italy.
  • Aguilar AHR; Division of Surgical Oncology and Digestive Surgery, Department of Oncology, San Luigi University Hospital, University of Turin, Orbassano (Turin), Italy.
  • Solej M; Division of Surgical Oncology and Digestive Surgery, Department of Oncology, San Luigi University Hospital, University of Turin, Orbassano (Turin), Italy.
  • Azzolina D; Department of Environmental and Preventive Sciences, University of Ferrara, Via Fossato di Mortara, Ferrara, Italy.
  • Marchiori G; Department of Surgical Sciences, University of Turin, Turin, Italy.
  • Corcione F; Chirurgia Oncologica e Miniinvasiva Clinica Mediterranea Napoli, University of Naples Federico II, Naples, Italy.
  • Bracale U; Minimally Invasive, General and Oncologic Surgery Unit, University Federico II of Naples, Naples, Italy.
  • Peltrini R; Minimally Invasive, General and Oncologic Surgery Unit, University Federico II of Naples, Naples, Italy.
  • Di Nuzzo MM; Minimally Invasive, General and Oncologic Surgery Unit, University Federico II of Naples, Naples, Italy.
  • Baldazzi G; ASST Ovest Milanese, P.O. Nuovo Ospedale di Legnano, Legnano, Italy.
  • Cassini D; ASST Ovest Milanese, P.O. Nuovo Ospedale di Legnano, Legnano, Italy.
  • Sica GS; Minimally Invasive and Gastrointestinal Surgery Unit, Università e Policlinico Tor Vergata, Rome, Italy.
  • Pirozzi B; Minimally Invasive and Gastrointestinal Surgery Unit, Università e Policlinico Tor Vergata, Rome, Italy.
  • Muratore A; Surgical Department, Edoardo Agnelli Hospital, Pinerolo, Italy.
  • Calabrò M; Surgical Department, Edoardo Agnelli Hospital, Pinerolo, Italy.
  • Jovine E; IRCCS AOU of Bologna, University of Bologna, Bologna, Italy.
  • Lombardi R; AOU of Bologna, Bologna, Italy.
  • Anania G; Dipartimento Scienze Mediche, Università di Ferrara, Ferrara, Italy.
  • Chiozza M; Dipartimento Scienze Mediche, Università di Ferrara, Ferrara, Italy.
  • Petz W; Digestive Surgery, European Institute of Oncology-IRCCS, Milan, Italy.
  • Pizzini P; Digestive Surgery, European Institute of Oncology-IRCCS, Milan, Italy.
  • Persiani R; Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
  • Biondi A; Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
  • Reddavid R; Division of Surgical Oncology and Digestive Surgery, Department of Oncology, San Luigi University Hospital, University of Turin, Orbassano (Turin), Italy. rossella.reddavid@unito.it.
Ann Surg Oncol ; 31(3): 1671-1680, 2024 Mar.
Article em En | MEDLINE | ID: mdl-38087139
BACKGROUND: Although complete mesocolic excision (CME) is supposed to be associated with a higher lymph node (LN) yield, decreased local recurrence, and survival improvement, its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials. METHOD: This is a multicenter, randomized, superiority trial (NCT04871399). The 3-year disease-free survival (DFS) was the primary end point of the study. The secondary end points were safety (duration of operation, perioperative complications, hospital length of stay), oncologic outcomes (number of LNs retrieved, 3- and 5-year overall survival, 5-year DFS), and surgery quality (specimen length, area and integrity rate of mesentery, length of ileocolic and middle-colic vessels). The trial design required the LN yield to be higher in the CME group at interim analysis. RESULTS: Interim data analysis is presented in this report. The study enrolled 258 patients in nine referral centers. The number of LNs retrieved was significantly higher after CME (25 vs. 20; p = 0.012). No differences were observed with respect to intra- or post-operative complications, postoperative mortality, or duration of surgery. The hospital stay was even shorter after CME (p = 0.039). Quality of surgery indicators were higher in the CME arm of the study. Survival data still were not available. CONCLUSIONS: Interim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications. The study documented with evidence that quality of surgery and LN yield are higher after CME, and this is essential for continuation of patient recruitment and implementation of an optimal comparison. Trial registration The trial was registered at ClinicalTrials.gov with the code NCT04871399 and with the acronym CoME-In trial.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Laparoscopia / Neoplasias do Colo / Oncologia Cirúrgica / Mesocolo Limite: Humans País/Região como assunto: Europa Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Laparoscopia / Neoplasias do Colo / Oncologia Cirúrgica / Mesocolo Limite: Humans País/Região como assunto: Europa Idioma: En Ano de publicação: 2024 Tipo de documento: Article