Christophe Mariette1, Sheraz R Markar1, Tienhan S Dabakuyo-Yonli1, Bernard Meunier1, Denis Pezet1, Denis Collet1, Xavier B D'Journo1, Cécile Brigand1, Thierry Perniceni1, Nicolas Carrère1, Jean-Yves Mabrut1, Simon Msika1, Frédérique Peschaud1, Michel Prudhomme1, Franck Bonnetain1, Guillaume Piessen1. 1. From the Department of Digestive and Oncologic Surgery, Claude Huriez University Hospital, and INSERM, Centre Hospitalier Universitaire (CHU) Lille, Unité Mixte de Recherche 1172-JPARC Jean-Pierre Aubert Research Center, Team "Mucins, epithelial differentiation, and carcinogenesis," Université de Lille, Lille (C.M., G.P.), the Epidemiology and Quality of Life Unit, INSERM Unité 1231, Centre Georges François Leclerc, Dijon (T.S.D.-Y.), the Department of Hepatobiliary and Digestive Surgery, CHU Rennes, University of Rennes 1, Rennes (B.M.), Université Clermont Auvergne, INSERM, CHU Clermont-Ferrand, Service de Chirurgie Digestive, Clermont-Ferrand (D.P.), the Department of Digestive Surgery, Haut Lévèque University Hospital, Bordeaux (D.C.), the Department of Thoracic Surgery, Hôpital Nord, Aix-Marseille Université, Assistance Publique-Hôpitaux de Marseille, Marseille (X.B.D.), the Department of Digestive Surgery, Strasbourg University, Strasbourg (C.B.), the Department of Digestive Surgery, Institut Mutualiste Montsouris, Paris (T.P.), the Department of Digestive Surgery, Purpan Hospital, CHU Toulouse, Université Toulouse III, Toulouse (N.C.), the Department of General Surgery and Liver Transplantation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Equipe Mixte de Recherche 3738, Université Lyon 1, Lyon (J.-Y.M.), the Department of Digestive and General Surgery, CHU Louis Mourier, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris 7, Denis Diderot, PRES Sorbonne Paris Cité, Colombes (S.M.), the Department of Surgery and Oncology, Centre Hospitalier Universitaire Ambroise Paré, AP-HP, Université de Versailles, Boulogne-Billancourt (F.P.), the Department of Digestive Surgery, CHU Nîmes, Nîmes (M.P.), and the Methodology and Quality of Life Unit in Cancer, INSERM Unité Mixte de Recherche 1098, University Hospital of Besançon, Besançon (F.B.) - all in France; and the Department of Surgery and Cancer, Imperial College, London (S.R.M.).
Abstract
BACKGROUND:Postoperative complications, especially pulmonary complications, affect more than half the patients who undergo open esophagectomy for esophageal cancer. Whether hybrid minimally invasive esophagectomy results in lower morbidity than open esophagectomy is unclear. METHODS: We performed a multicenter, open-label, randomized, controlled trial involving patients 18 to 75 years of age with resectable cancer of the middle or lower third of the esophagus. Patients were randomly assigned to undergo transthoracic open esophagectomy (open procedure) or hybrid minimally invasive esophagectomy (hybrid procedure). Surgical quality assurance was implemented by the credentialing of surgeons, standardization of technique, and monitoring of performance. Hybrid surgery comprised a two-field abdominal-thoracic operation (also called an Ivor-Lewis procedure) with laparoscopic gastric mobilization and open right thoracotomy. The primary end point was intraoperative or postoperative complication of grade II or higher according to the Clavien-Dindo classification (indicating major complication leading to intervention) within 30 days. Analyses were done according to the intention-to-treat principle. RESULTS:From October 2009 through April 2012, we randomly assigned 103 patients to the hybrid-procedure group and 104 to the open-procedure group. A total of 312 serious adverse events were recorded in 110 patients. A total of 37 patients (36%) in the hybrid-procedure group had a major intraoperative or postoperative complication, as compared with 67 (64%) in the open-procedure group (odds ratio, 0.31; 95% confidence interval [CI], 0.18 to 0.55; P<0.001). A total of 18 of 102 patients (18%) in the hybrid-procedure group had a major pulmonary complication, as compared with 31 of 103 (30%) in the open-procedure group. At 3 years, overall survival was 67% (95% CI, 57 to 75) in the hybrid-procedure group, as compared with 55% (95% CI, 45 to 64) in the open-procedure group; disease-free survival was 57% (95% CI, 47 to 66) and 48% (95% CI, 38 to 57), respectively. CONCLUSIONS: We found that hybrid minimally invasive esophagectomy resulted in a lower incidence of intraoperative and postoperative major complications, specifically pulmonary complications, than open esophagectomy, without compromising overall and disease-free survival over a period of 3 years. (Funded by the French National Cancer Institute; ClinicalTrials.gov number, NCT00937456 .).
RCT Entities:
BACKGROUND: Postoperative complications, especially pulmonary complications, affect more than half the patients who undergo open esophagectomy for esophageal cancer. Whether hybrid minimally invasive esophagectomy results in lower morbidity than open esophagectomy is unclear. METHODS: We performed a multicenter, open-label, randomized, controlled trial involving patients 18 to 75 years of age with resectable cancer of the middle or lower third of the esophagus. Patients were randomly assigned to undergo transthoracic open esophagectomy (open procedure) or hybrid minimally invasive esophagectomy (hybrid procedure). Surgical quality assurance was implemented by the credentialing of surgeons, standardization of technique, and monitoring of performance. Hybrid surgery comprised a two-field abdominal-thoracic operation (also called an Ivor-Lewis procedure) with laparoscopic gastric mobilization and open right thoracotomy. The primary end point was intraoperative or postoperative complication of grade II or higher according to the Clavien-Dindo classification (indicating major complication leading to intervention) within 30 days. Analyses were done according to the intention-to-treat principle. RESULTS: From October 2009 through April 2012, we randomly assigned 103 patients to the hybrid-procedure group and 104 to the open-procedure group. A total of 312 serious adverse events were recorded in 110 patients. A total of 37 patients (36%) in the hybrid-procedure group had a major intraoperative or postoperative complication, as compared with 67 (64%) in the open-procedure group (odds ratio, 0.31; 95% confidence interval [CI], 0.18 to 0.55; P<0.001). A total of 18 of 102 patients (18%) in the hybrid-procedure group had a major pulmonary complication, as compared with 31 of 103 (30%) in the open-procedure group. At 3 years, overall survival was 67% (95% CI, 57 to 75) in the hybrid-procedure group, as compared with 55% (95% CI, 45 to 64) in the open-procedure group; disease-free survival was 57% (95% CI, 47 to 66) and 48% (95% CI, 38 to 57), respectively. CONCLUSIONS: We found that hybrid minimally invasive esophagectomy resulted in a lower incidence of intraoperative and postoperative major complications, specifically pulmonary complications, than open esophagectomy, without compromising overall and disease-free survival over a period of 3 years. (Funded by the French National Cancer Institute; ClinicalTrials.gov number, NCT00937456 .).
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