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撤回:胃癌腺癌扩大与有限淋巴结清扫技术对比

WITHDRAWN: Extended versus limited lymph nodes dissection technique for adenocarcinoma of the stomach.

作者信息

McCulloch Peter, Nita Marcelo Eidi, Kazi Hussain, Gama-Rodrigues Joaquin J

机构信息

Nuffield Department of Surgery, John Radcliffe Hospital, Oxford, UK.

出版信息

Cochrane Database Syst Rev. 2012 Jan 18;1:CD001964. doi: 10.1002/14651858.CD001964.pub3.

Abstract

BACKGROUND

Surgeons disagree about the merits and risks of radical lymph node clearance during gastrectomy for cancer.

OBJECTIVES

To evaluate survival and peri-operative mortality after limited or extended lymph node removal during gastrectomy for cancer.

SEARCH METHODS

We searched MEDLINE, EMBASE, CancerLit, LILACS, Central Medical Journal Japanese Database and the Cochrane register, references from relevant articles and conference proceedings. We contacted known workers in the field. For the updated review, the Cochrane Library, M EDLINE , E MBASE and LILACS were searched from 2001 to April 2009.

SELECTION CRITERIA

Studies published after 1970 which reported 5 year survival or postoperative mortality rates, and clearly defined the node dissection performed, were considered. We excluded studies which overtly included patients receiving perioperative chemotherapy, and comparisons with clear systematic treatment allocation bias. Randomised controlled trials (RCTs), non-randomised comparisons and observational studies were considered separately.

DATA COLLECTION AND ANALYSIS

Three reviewers selected trials for inclusion. Quality assessment and data extraction were performed independently by two reviewers. Results of trials of similar design were pooled. Meta-analysis was performed separately for randomised and non-randomised comparisons.

MAIN RESULTS

Two randomised and two non-randomised comparisons of limited (D1) versus extended (D2) node dissection and 11 cohort studies of either D1 or D2 resection were analysed. Meta-analysis of randomised trials did not reveal any survival benefit for extended lymph node dissection (Risk ratio = 0.95 (95% CI 0.83 - 1.09), but showed increased postoperative mortality (RR 2.23, 95% CI 1.45 - 3.45). Pre-specified subgroup analysis suggested a possible benefit in stage T3+ tumours (RR = 0.68, 95% CI 0.42-1.10). Non-randomised comparisons showed no significant survival benefit for extended dissection (RR 0.92, 95% CI 0.83 -1.02), but decreased mortality (RR 0.65, 95% CI 0.45-0.93). Subgroup analysis showed apparent benefit in UICC stage II and IIIa. Observational studies of D2 resection reported much better mortality and survival than those of D1 surgery, but the settings were strikingly different.

AUTHORS' CONCLUSIONS: D2 dissection carries increased mortality risks associated with spleen and pancreas resection, and probably with inexperience and low case volumes. Randomised studies show no evidence of overall survival benefit, but possible benefit in T3+ tumours. These results may be confounded by surgical learning curves and poor surgeon compliance. Non-randomised comparisons suggest a possible survival benefit for D2 in intermediate UICC stages. Observational studies show high 5 year survival and low operative mortality after D2 dissection in experienced units, and poor results after D1 dissection in non-specialist units. Further studies, with precautions to eliminate learning curve effects, contamination and non-compliance, are needed to evaluate D2 dissection in intermediate stage gastric cancer.

摘要

背景

外科医生对于胃癌胃切除术中根治性淋巴结清扫的利弊及风险存在分歧。

目的

评估胃癌胃切除术中进行有限或扩大淋巴结切除后的生存率及围手术期死亡率。

检索方法

我们检索了MEDLINE、EMBASE、CancerLit、LILACS、日本中央医学杂志数据库以及Cochrane注册库,相关文章的参考文献及会议论文集。我们联系了该领域的知名研究人员。为进行更新综述,于2001年至2009年4月检索了Cochrane图书馆、MEDLINE、EMBASE和LILACS。

选择标准

纳入1970年后发表的报告5年生存率或术后死亡率,且明确界定所进行的淋巴结清扫范围的研究。我们排除了明显纳入接受围手术期化疗患者的研究,以及存在明显系统治疗分配偏倚的对照研究。分别考虑随机对照试验(RCT)、非随机对照及观察性研究。

数据收集与分析

三名综述作者选择纳入试验。由两名综述作者独立进行质量评估和数据提取。对设计相似的试验结果进行汇总。对随机对照和非随机对照分别进行Meta分析。

主要结果

分析了两项有限(D1)与扩大(D2)淋巴结清扫的随机对照及两项非随机对照,以及11项关于D1或D2切除的队列研究。随机对照试验的Meta分析未显示扩大淋巴结清扫有任何生存获益(风险比=0.95(95%CI 0.83 - 1.09)),但显示术后死亡率增加(RR 2.23,95%CI 1.45 - 3.45)。预先设定的亚组分析提示在T3+期肿瘤中可能存在获益(RR = 0.68, 95%CI 0.42 - 1.10)。非随机对照未显示扩大清扫有显著生存获益(RR 0.92, 95%CI 0.83 - 1.02),但死亡率降低(RR 0.65, 95%CI 0.45 - 0.93)。亚组分析显示在国际抗癌联盟(UICC)II期和IIIa期有明显获益。关于D2切除的观察性研究报告的死亡率和生存率远优于D1手术,但研究背景差异显著。

作者结论

D2清扫与脾脏和胰腺切除相关的死亡风险增加有关,可能还与经验不足和病例数少有关。随机研究未显示总体生存获益的证据,但在T3+期肿瘤中可能存在获益。这些结果可能因手术学习曲线和外科医生依从性差而混淆。非随机对照提示在UICC中期D2可能有生存获益。观察性研究显示,在经验丰富的单位,D2清扫后5年生存率高且手术死亡率低,而在非专科单位,D1清扫效果差。需要进一步研究,采取措施消除学习曲线效应、污染和不依从性,以评估中期胃癌的D2清扫。

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