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复合微创食管切除术治疗食管癌
Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer


Christophe Mariette ... 肿瘤 • 2019.01.10
相关阅读
• 食管癌微创手术

摘要


背景

因食管癌接受开放食管切除术的患者有一半以上会出现术后并发症,尤其是肺部并发症。目前尚不明确复合微创食管切除术与开放食管切除术相比可否降低并发症发病率。

 

方法

我们开展了一项多中心、开放标签的随机对照试验,纳入患可切除的食管中段癌或下段癌,年龄18~75岁的患者。患者被随机分组,分别接受经胸开放食管切除术(开放手术)或复合微创食管切除术(复合手术)。通过鉴定外科医师资质、标准化操作和监测表现三种方式保证外科手术质量。复合手术包括胸腹二野手术(也称为Ivor-Lewis手术),即腹腔镜胃游离术和右侧开胸术。主要终点是术中或术后30日内根据Clavien-Dindo分级系统判定的Ⅱ级或更高级别并发症(表示需要干预的主要并发症)。根据意向治疗原则进行分析。

 

结果

从2009年10月至2012年4月,我们将103例患者随机分配到复合手术组,将104例患者随机分配到开放手术组。根据记录,110例患者共发生312起严重不良事件。复合手术组共有37例患者(36%)发生术中或术后主要并发症,而开放手术组为67例(64%)(比值比,0.31;95%置信区间[CI],0.18~0.55;P<0.001)。复合手术组102例患者中共有18例(18%)发生肺部主要并发症,而开放手术组103例患者中有31例(30%)。3年时,复合手术组的总生存率为67%(95% CI,57%~75%),而开放手术组为55%(95% CI,45%~64%);无病生存率分别为57%(95% CI,47%~66%)和48%(95% CI,38%~57%)。

 

结论

我们发现,与开放食管切除术相比,复合微创食管切除术降低了术中和术后主要并发症,尤其是肺部并发症的发生率,同时未影响3年期间的总生存率和无病生存率(由法国国家癌症研究所[National Cancer Institute]资助;在ClinicalTrials.gov注册号为NCT00937456)。





作者信息

Christophe Mariette, M.D., Ph.D., Sheraz R. Markar, M.D., Ph.D., Tienhan S. Dabakuyo-Yonli, Pharm.D., Ph.D., Bernard Meunier, M.D., Denis Pezet, M.D., Ph.D., Denis Collet, M.D., Ph.D., Xavier B. D’Journo, M.D., Ph.D., Cécile Brigand, M.D., Ph.D., Thierry Perniceni, M.D., Nicolas Carrère, M.D., Ph.D., Jean-Yves Mabrut, M.D., Ph.D., Simon Msika, M.D., Ph.D., Frédérique Peschaud, M.D., Ph.D., Michel Prudhomme, M.D., Ph.D., Franck Bonnetain, Ph.D., and Guillaume Piessen, M.D., Ph.D. for the Fédération de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Group*
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.). Address reprint requests to Dr. Piessen at the Department of Digestive and Oncologic Surgery, Claude Huriez University Hospital, Rue Michel Polonovski, F-59000 Lille, France, or at guillaume.piessen@chru-lille.fr. Christophe Mariette, M.D., Ph.D., and Franck Bonnetain, Ph.D., are deceased. *A complete list of the collaborators from the Fédération de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Group is provided in the Supplementary Appendix, available at NEJM.org.

 

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