微创与开放食管切除术的比较：先前报道的随机对照试验的 3 年随访：TIME 试验。

Minimally Invasive Versus Open Esophageal Resection: Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial.

机构信息

*Department of Gastrointestinal Surgery, VU University Medical Center, Amsterdam, the Netherlands †Department of Surgery, Hospital Universitari de Girona Dr Josep Trueta, Girona, Spain ‡Department of Surgery, I.R.C.C.S. Policlinico San Donato University of Milan, Milan, Italy §Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands ¶Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands.

出版信息

Ann Surg. 2017 Aug;266(2):232-236. doi: 10.1097/SLA.0000000000002171.

DOI:10.1097/SLA.0000000000002171

PMID:28187044

Abstract

OBJECTIVE

The aim of this study was to investigate 3-year survival following a randomized controlled trial comparing minimally invasive with open esophagectomy in patients with esophageal cancer.

BACKGROUND

Research on minimally invasive esophagectomy (MIE) has shown faster postoperative recovery and a marked decrease in pulmonary complications. Debate is ongoing as to whether the procedure is equivalent to open resection regarding oncologic outcomes. The study is a follow-up study of the TIME-trial (traditional invasive vs minimally invasive esophagectomy, a multicenter, randomized trial).

METHODS

Between June 2009 and March 2011, patients with a resectable intrathoracic esophageal carcinoma, including the gastroesophageal junction tumors (Siewert I), were randomized between open and MI esophagectomy with curative intent. Primary outcome was 3-year disease-free survival. Secondary outcomes include overall survival, lymph node yield, short-term morbidity, mortality, complications, radicality, local recurrence, and metastasis. Analysis was by intention-to-treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. Both trial protocol and short-term results have been published previously.

RESULTS

One hundred fifteen patients were included from 5 European hospitals and randomly assigned to open (n = 56) or MI esophagectomy (n = 59). Combined overall 3-year survival was 40.4% (SD 7.7%) in the open group versus 50.5% (SD 8%) in the minimally invasive group (P = 0.207). The hazard ratio (HR) is 0.883 (0.540 to 1.441) for MIE compared with open surgery. Disease-free 3-year survival was 35.9% (SD 6.8%) in the open versus 40.2% (SD 6.9%) in the MI group [HR 0.691 (0.389 to 1.239).

CONCLUSIONS

The study presented here depicted no differences in disease-free and overall 3-year survival for open and MI esophagectomy. These results, together with short-term results, further support the use of minimally invasive surgical techniques in the treatment of esophageal cancer.

摘要

目的

本研究旨在调查一项随机对照试验的 3 年生存率，该试验比较了微创与开放性食管癌切除术。

背景

微创食管切除术（MIE）的研究表明，术后恢复更快，肺部并发症明显减少。关于该手术在肿瘤学结果方面是否与开放性切除术相当，目前仍存在争议。该研究是 TIME 试验（传统侵袭性与微创食管切除术，一项多中心随机试验）的随访研究。

方法

2009 年 6 月至 2011 年 3 月，对可切除的胸内食管癌患者（包括胃食管交界处肿瘤[Siewert I]）进行了开放性和微创 MIE 根治性随机分组。主要结局是 3 年无病生存率。次要结局包括总生存率、淋巴结产量、短期发病率、死亡率、并发症、根治性、局部复发和转移。分析采用意向治疗。该试验在荷兰试验注册中心（NTR TC 2452）注册。试验方案和短期结果均已先前发表。

结果

从 5 家欧洲医院共纳入 115 例患者，并随机分为开放性（n = 56）或微创 MIE 组（n = 59）。联合总 3 年生存率在开放性组为 40.4%（标准差 7.7%），微创组为 50.5%（标准差 8%）（P = 0.207）。与开放性手术相比，MIE 的风险比（HR）为 0.883（0.540 至 1.441）。开放性组 3 年无病生存率为 35.9%（标准差 6.8%），微创组为 40.2%（标准差 6.9%）[HR 0.691（0.389 至 1.239）]。