杂交微创食管癌切除术。

Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer.

机构信息

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.).

出版信息

N Engl J Med. 2019 Jan 10;380(2):152-162. doi: 10.1056/NEJMoa1805101.

DOI:10.1056/NEJMoa1805101

PMID:30625052

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 .).

摘要

背景

术后并发症，尤其是肺部并发症，影响了半数以上接受开放性食管癌切除术的患者。杂交微创食管切除术是否比开放性食管切除术发病率更低仍不清楚。

方法

我们进行了一项多中心、开放标签、随机、对照临床试验，纳入年龄在 18 岁至 75 岁之间、可切除的中段或下段食管癌患者。患者被随机分配接受经胸开放性食管切除术（开放性手术）或杂交微创食管切除术（杂交手术）。通过对外科医生的资质认证、技术标准化和绩效监测来实施手术质量保证。杂交手术包括经腹-经胸两野手术（也称为 Ivor-Lewis 手术），联合腹腔镜胃游离术和开胸右开胸术。主要终点是 30 天内根据 Clavien-Dindo 分级（提示需要干预的主要并发症）为 II 级或更高级别的术中或术后并发症。分析按照意向治疗原则进行。

结果

2009 年 10 月至 2012 年 4 月，我们将 103 例患者随机分配至杂交手术组，104 例患者分配至开放性手术组。在 110 例患者中，共记录到 312 例严重不良事件。杂交手术组 37 例（36%）患者发生主要术中或术后并发症，而开放性手术组 67 例（64%）（比值比，0.31；95%置信区间[CI]，0.18 至 0.55；P<0.001）。杂交手术组 18 例（18%）患者发生主要肺部并发症，而开放性手术组 31 例（30%）（比值比，0.31；95%置信区间[CI]，0.18 至 0.55；P<0.001）。在 3 年时，杂交手术组的总生存率为 67%（95%CI，57 至 75），而开放性手术组为 55%（95%CI，45 至 64）；无病生存率分别为 57%（95%CI，47 至 66）和 48%（95%CI，38 至 57）。