Hüttner Felix J, Fitzmaurice Christina, Schwarzer Guido, Seiler Christoph M, Antes Gerd, Büchler Markus W, Diener Markus K
Department of General, Visceral and Transplant Surgery, University of Heidelberg, Im Neuenheimer Feld 110, Heidelberg, Germany, 69120.
Cochrane Database Syst Rev. 2016 Feb 16;2(2):CD006053. doi: 10.1002/14651858.CD006053.pub6.
Pancreatic cancer is the fourth-leading cause of cancer death for both, men and women. The standard treatment for resectable tumours consists of a classic Whipple (CW) operation or a pylorus-preserving pancreaticoduodenectomy (PPW). It is unclear which of these procedures is more favourable in terms of survival, postoperative mortality, complications, and quality of life.
The objective of this systematic review was to compare the effectiveness of CW and PPW techniques for surgical treatment of cancer of the pancreatic head and the periampullary region.
We conducted searches on 28 March 2006, 11 January 2011, 9 January 2014, and 18 August 2015 to identify all randomised controlled trials (RCTs), while applying no language restrictions. We searched the following electronic databases on 18 August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE) from the Cochrane Library (2015, Issue 8); MEDLINE (1946 to August 2015); and EMBASE (1980 to August 2015). We also searched abstracts from Digestive Disease Week and United European Gastroenterology Week (1995 to 2010); we did not update this part of the search for the 2014 and 2015 updates because the prior searches did not contribute any additional information. We identified two additional trials through the updated search in 2015.
RCTs comparing CW versus PPW including participants with periampullary or pancreatic carcinoma.
Two review authors independently extracted data from the included trials. We used a random-effects model for pooling data. We compared binary outcomes using odds ratios (ORs), pooled continuous outcomes using mean differences (MDs), and used hazard ratios (HRs) for meta-analysis of survival. Two review authors independently evaluated the methodological quality and risk of bias of included trials according to the standards of The Cochrane Collaboration.
We included eight RCTs with a total of 512 participants. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. Postoperative mortality (OR 0.64, 95% confidence interval (CI) 0.26 to 1.54; P = 0.32), overall survival (HR 0.84, 95% CI 0.61 to 1.16; P = 0.29), and morbidity showed no significant differences, except of delayed gastric emptying, which significantly favoured CW (OR 3.03, 95% CI 1.05 to 8.70; P = 0.04). Furthermore, we noted that operating time (MD -45.22 minutes, 95% CI -74.67 to -15.78; P = 0.003), intraoperative blood loss (MD -0.32 L, 95% CI -0.62 to -0.03; P = 0.03), and red blood cell transfusion (MD -0.47 units, 95% CI -0.86 to -0.07; P = 0.02) were significantly reduced in the PPW group. All significant results were associated with low-quality evidence based on GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria.
AUTHORS' CONCLUSIONS: Current evidence suggests no relevant differences in mortality, morbidity, and survival between the two operations. However, some perioperative outcome measures significantly favour the PPW procedure. Given obvious clinical and methodological heterogeneity, future high-quality RCTs of complex surgical interventions based on well-defined outcome parameters are required.
胰腺癌是男性和女性癌症死亡的第四大原因。可切除肿瘤的标准治疗方法包括经典的惠普尔(CW)手术或保留幽门的胰十二指肠切除术(PPW)。目前尚不清楚这两种手术在生存率、术后死亡率、并发症和生活质量方面哪种更具优势。
本系统评价的目的是比较CW和PPW技术在治疗胰头和壶腹周围区域癌症方面的有效性。
我们于2006年3月28日、2011年1月11日、2014年1月9日和2015年8月18日进行了检索,以识别所有随机对照试验(RCT),且不设语言限制。我们于2015年8月18日检索了以下电子数据库:Cochrane对照试验中心注册库(CENTRAL)、Cochrane系统评价数据库(CDSR)和Cochrane图书馆(2015年第8期)中的疗效评价文摘数据库(DARE);MEDLINE(1946年至2015年8月);以及EMBASE(1980年至2015年8月)。我们还检索了消化疾病周和欧洲胃肠病学联合会周(1995年至2010年)的摘要;由于之前的检索未提供任何额外信息,因此我们未对2014年和2015年更新部分进行此部分检索。通过2015年的更新检索,我们识别出另外两项试验。
比较CW与PPW的RCT,纳入对象为壶腹周围或胰腺癌患者。
两位综述作者独立从纳入的试验中提取数据。我们使用随机效应模型合并数据。我们使用比值比(OR)比较二分类结局,使用平均差(MD)合并连续结局,并使用风险比(HR)进行生存的荟萃分析。两位综述作者根据Cochrane协作网的标准独立评估纳入试验的方法学质量和偏倚风险。
我们纳入了八项RCT,共512名参与者。我们的严格评价显示,在方法学质量和结局参数方面存在巨大异质性。术后死亡率(OR 0.64,95%置信区间(CI)0.26至1.54;P = 0.32)、总生存期(HR 0.84,95%CI 0.61至1.16;P = 0.29)和发病率无显著差异,但胃排空延迟除外,胃排空延迟显著有利于CW(OR 3.03,95%CI 1.05至8.70;P = 0.04)。此外,我们注意到PPW组的手术时间(MD -45.22分钟,95%CI -74.67至-15.78;P = 0.003)、术中失血量(MD -0.32 L,95%CI -0.62至-0.03;P = 0.03)和红细胞输注量(MD -0.47单位,95%CI -0.86至-0.07;P = 0.02)均显著减少。根据推荐分级、评估、制定与评价(GRADE)标准,所有显著结果均与低质量证据相关。
目前的证据表明,两种手术在死亡率、发病率和生存率方面无相关差异。然而,一些围手术期结局指标显著有利于PPW手术。鉴于明显的临床和方法学异质性,未来需要基于明确结局参数的高质量复杂手术干预RCT。