Diener M K, Heukaufer C, Schwarzer G, Seiler C M, Antes G, Buchler M W, Knaebel H P
University of Heidelberg, Department of General Surgery, Im Neuenheimer Feld 110, Heidelberg, Germany, 69120.
Cochrane Database Syst Rev. 2008 Apr 16(2):CD006053. doi: 10.1002/14651858.CD006053.pub2.
Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple operation or a pylorus-preserving pancreaticoduodenectomy but it is still unclear which of the two procedures is more favourable in terms of survival, mortality, complications, perioperative factors and quality of life.
Several publications pointed out both advantages and disadvantages of both techniques and the current basis of evidence remains unclear. The objective of this systematic review is to compare the effectiveness of each technique.
A search was conducted to identify all published and unpublished randomised controlled trials. Trials were identified by searching the following electronic databases - The Cochrane Library, MEDLINE, EMBASE and Current Contents. Reference lists from trials selected by electronic searching were hand-searched to identify further relevant trials.
Randomised controlled trials (RCTs) comparing the classical Whipple (CW) with the pylorus-preserving pancreaticoduodenectomy (PPW) were considered eligible if patients with periampullary or pancreatic carcinoma were included.
Two authors independently extracted data for included studies. A random-effects model was used for pooling data from the different trials. Binary outcomes were compared using odds ratios, continuous outcomes were pooled using weighted mean differences and hazard ratios were used to for the meta-analysis of survival data. The methodological quality of included studies was evaluated independently by two authors according to quality standards and by using a questionnaire that covers different aspects of quality.
1235 abstracts were retrieved and checked for eligibility and seven RCTs were finally included. The critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. The comparison of overall in-hospital mortality (odds ratio 0.49; 95% CI 0.17 to 1.40; P=0.18), overall survival (hazard ratio 0.84; 95% CI 0.61 to 1.16; P=0.29) and morbidity showed no significant difference. However, operating time (weighted mean difference -68.26 min; 95% CI -105.70 to -30.83; P=0.0004) and intra-operative blood loss (weighted mean difference -0.76 ml; 95% CI -0.96 to -0.56; P<0.00001) were significantly reduced in the PPW group.
AUTHORS' CONCLUSIONS: There is no evidence of relevant differences in mortality, morbidity and survival between the PPW and the CW. Given obvious clinical and methodological inter-study heterogeneity, future efforts have to be undertaken to perform high quality RCTs of complex surgical interventions on the basis of well defined outcome parameters.
胰腺癌是男性癌症死亡的第四大原因,女性的第五大原因。可切除肿瘤的标准治疗方法是经典的惠普尔手术或保留幽门的胰十二指肠切除术,但在生存率、死亡率、并发症、围手术期因素和生活质量方面,这两种手术哪种更有利仍不清楚。
多篇文献指出了两种技术的优缺点,目前的证据基础仍不明确。本系统评价的目的是比较每种技术的有效性。
进行检索以识别所有已发表和未发表的随机对照试验。通过检索以下电子数据库来识别试验——考克兰图书馆、医学文献数据库、荷兰医学文摘数据库和现刊目次。对通过电子检索选择的试验的参考文献列表进行手工检索,以识别更多相关试验。
如果纳入了壶腹周围或胰腺癌患者,比较经典惠普尔手术(CW)和保留幽门的胰十二指肠切除术(PPW)的随机对照试验(RCT)被认为符合条件。
两位作者独立提取纳入研究的数据。采用随机效应模型汇总不同试验的数据。使用比值比比较二元结局,使用加权平均差汇总连续结局,并使用风险比进行生存数据的荟萃分析。两位作者根据质量标准并使用涵盖质量不同方面的问卷,独立评估纳入研究的方法学质量。
检索到1235篇摘要并检查其是否符合条件,最终纳入7项RCT。批判性评价显示,在方法学质量和结局参数方面存在巨大异质性。总体住院死亡率(比值比0.49;95%可信区间0.17至1.40;P=0.18)、总生存率(风险比0.84;95%可信区间0.61至1.16;P=0.29)和发病率的比较无显著差异。然而,PPW组的手术时间(加权平均差-68.26分钟;95%可信区间-105.70至-30.83;P=0.0004)和术中失血量(加权平均差-0.76毫升;95%可信区间-0.96至-0.56;P<0.00001)显著减少。
没有证据表明PPW和CW在死亡率、发病率和生存率方面存在相关差异。鉴于研究间明显的临床和方法学异质性,未来必须努力在明确界定的结局参数基础上进行高质量的复杂手术干预RCT。