Multicenter phase III randomized trial comparing laparoscopy and laparotomy for colon cancer surgery in patients older than 75 years: the CELL study, a Fédération de Recherche en Chirurgie (FRENCH) trial
Gilles Manceau,
Antoine Brouquet,
Pascal Chaibi,
Guillaume Passot,
Olivier Bouché,
Murielle Mathonnet,
Jean-Marc Regimbeau,
Rea Lo Dico,
Jérémie H. Lefèvre,
Frédérique Peschaud,
Olivier Facy,
Enrico Volpin,
Elie Chouillard,
Laura Beyert-Berjot,
Marc Verny,
Mehdi Karoui,
Stéphane Benoist
Affiliations
Gilles Manceau
Department of Digestive and Hepato-Pancreato-Biliary Surgery, Sorbonne University, Assistance Publique Hôpitaux de Paris, Pitié-Salpêtrière Hospital
Antoine Brouquet
Department of Surgery, Paris-Sud University, Assistance Publique Hôpitaux de Paris, Bicetre Hospital
Pascal Chaibi
Unité d’onco-hémato-gériatrie, Sorbonne University, Assistance Publique Hôpitaux de Paris, Charles Foix Hospital
Guillaume Passot
Department of Surgical Oncology, CHU Lyon Sud, Hospices Civils de Lyon
Olivier Bouché
Department of Digestive Oncology, Reims University Hospital
Murielle Mathonnet
Department of Digestive and Endocrine Surgery, Dupuytren University Hospital, Limoges University
Jean-Marc Regimbeau
Department of Digestive and Oncological Surgery, Amiens University Hospital
Rea Lo Dico
Department of Visceral and Oncologic Surgery, Paris Diderot University, Assistance Publique - Hôpitaux de Paris, Saint-Louis Hospital
Jérémie H. Lefèvre
Department of Surgery, Sorbonne University, Assistance Publique - Hôpitaux de Paris, Saint-Antoine Hospital
Frédérique Peschaud
Department of Digestive, Oncologic and Metabolic Surgery, Versailles St-Quentin-en-Yvelines/Paris Saclay University, Assistance Publique - Hôpitaux de Paris Ambroise Paré Hospital
Olivier Facy
Department of Digestive Surgical Oncology, Dijon University Hospital
Enrico Volpin
Department of visceral and urological surgery, Simone Veil Hospital
Elie Chouillard
Department of Minimally Invasive Surgery, Poissy Saint Germain Medical Center
Laura Beyert-Berjot
Department of Digestive Surgery, Aix-Marseille Université
Marc Verny
Department of Geriatrics, Sorbonne University, Assistance Publique - Hôpitaux de Paris, Pitié-Salpêtrière Hospital
Mehdi Karoui
Department of Digestive and Hepato-Pancreato-Biliary Surgery, Sorbonne University, Assistance Publique Hôpitaux de Paris, Pitié-Salpêtrière Hospital
Stéphane Benoist
Department of Surgery, Paris-Sud University, Assistance Publique Hôpitaux de Paris, Bicetre Hospital
Abstract Background Several multicenter randomized controlled trials comparing laparoscopy and conventional open surgery for colon cancer have demonstrated that laparoscopic approach achieved the same oncological results while improving significantly early postoperative outcomes. These trials included few elderly patients, with a median age not exceeding 71 years. However, colon cancer is a disease of the elderly. More than 65% of patients operated on for colon cancer belong to this age group, and this proportion may become more pronounced in the coming years. In current practice, laparoscopy is underused in this population. Methods The CELL (Colectomy for cancer in the Elderly by Laparoscopy or Laparotomy) trial is a multicenter, open-label randomized, 2-arm phase III superiority trial. Patients aged 75 years or older with uncomplicated colonic adenocarcinoma or endoscopically unresectable colonic polyp will be randomized to either colectomy by laparoscopy or laparotomy. The primary endpoint of the study is overall postoperative morbidity, defined as any complication classification occurring up to 30 days after surgery. The secondary endpoints are: 30-day and 90-day postoperative mortality, 30-day readmission rate, quality of surgical resection, health-related quality of life and evolution of geriatric assessment. A 35 to 20% overall postoperative morbidity rate reduction is expected for patients operated on by laparoscopy compared with those who underwent surgery by laparotomy. With a two-sided α risk of 5% and a power of 80% (β = 0.20), 276 patients will be required in total. Discussion To date, no dedicated randomized controlled trial has been conducted to evaluate morbidity after colon cancer surgery by laparoscopy or laparotomy in the elderly and the benefits of laparoscopy is still debated in this context. Thus, a prospective multicenter randomized trial evaluating postoperative outcomes specifically in elderly patients operated on for colon cancer by laparoscopy or laparotomy with curative intent is warranted. If significant, such a study might change the current surgical practices and allow a significant improvement in the surgical management of this population, which will be the vast majority of patients treated for colon cancer in the coming years. Trial registration ClinicalTrials.gov NCT03033719 (January 27, 2017).
