Visceral Surgery, Hirslanden Klinik St. Anna, Luzern, Switzerland.
University Basel, Basel, Switzerland.
Cochrane Database Syst Rev. 2021 Jan 20;1(1):CD011490. doi: 10.1002/14651858.CD011490.pub2.
Pancreatic and periampullary adenocarcinomas account for some of the most aggressive malignancies, and the leading causes of cancer-related mortalities. Partial pancreaticoduodenectomy (PD) with negative resection margins is the only potentially curative therapy. The high prevalence of lymph node metastases has led to the hypothesis that wider excision with the removal of more lymphatic tissue could result in an improvement of survival, and higher rates of negative resection margins.
To compare overall survival following standard (SLA) versus extended lymph lymphadenectomy (ELA) for pancreatic head and periampullary adenocarcinoma. We also compared secondary outcomes, such as morbidity, mortality, and tumour involvement of the resection margins between the two procedures.
We searched CENTRAL, MEDLINE, PubMed, and Embase from 1973 to September 2020; we applied no language restrictions.
Randomised controlled trials (RCT) comparing PD with SLA versus PD with ELA, including participants with pancreatic head and periampullary adenocarcinoma.
Two review authors independently screened references and extracted data from study reports. We calculated pooled risk ratios (RR) for most binary outcomes except for postoperative mortality, for which we estimated a Peto odds ratio (Peto OR), and mean differences (MD) for continuous outcomes. We used a fixed-effect model in the absence of substantial heterogeneity (I² < 25%), and a random-effects model in cases of substantial heterogeneity (I² > 25%). Two review authors independently assessed risk of bias, and we used GRADE to assess the quality of the evidence for important outcomes.
We included seven studies with 843 participants (421 ELA and 422 SLA). All seven studies included Kaplan-Meier curves for overall survival. There was little or no difference in survival between groups (log hazard ratio (log HR) 0.12, 95% confidence interval (CI) -3.06 to 3.31; P = 0.94; seven studies, 843 participants; very low-quality evidence). There was little or no difference in postoperative mortality between the groups (Peto odds ratio (OR) 1.20, 95% CI 0.51 to 2.80; seven studies, 843 participants; low-quality evidence). Operating time was probably longer for ELA (mean difference (MD) 50.13 minutes, 95% CI 19.19 to 81.06 minutes; five studies, 670 participants; moderate-quality evidence). There was substantial heterogeneity between the studies (I² = 88%; P < 0.00001). There may have been more blood loss during ELA (MD 137.43 mL, 95% CI 11.55 to 263.30 mL; two studies, 463 participants; very low-quality evidence). There was substantial heterogeneity between the studies (I² = 81%, P = 0.02). There may have been more lymph nodes retrieved during ELA (MD 11.09 nodes, 95% CI 7.16 to 15.02; five studies, 670 participants; moderate-quality evidence). There was substantial heterogeneity between the studies (I² = 81%, P < 0.00001). There was little or no difference in the incidence of positive resection margins between groups (RR 0.81, 95% CI 0.58 to 1.13; six studies, 783 participants; very low-quality evidence).
AUTHORS' CONCLUSIONS: There is no evidence of an impact on survival with extended versus standard lymph node resection. However, the operating time may have been longer and blood loss greater in the extended resection group. In conclusion, current evidence neither supports nor refutes the effect of extended lymph lymphadenectomy in people with adenocarcinoma of the head of the pancreas.
胰腺和壶腹周围腺癌是一些侵袭性最强的恶性肿瘤,也是癌症相关死亡的主要原因。阴性切缘的胰十二指肠切除术(PD)是唯一潜在的治愈性治疗方法。淋巴结转移的高发率导致了这样一种假设,即通过切除更多的淋巴组织进行更广泛的切除可能会改善生存,并提高阴性切缘的比例。
比较标准(SLA)与扩展淋巴结清扫(ELA)治疗胰头和壶腹周围腺癌的总生存率。我们还比较了两种手术方法的次要结果,如发病率、死亡率和肿瘤对切缘的累及情况。
我们从 1973 年到 2020 年 9 月在 Cochrane 中心、MEDLINE、PubMed 和 Embase 进行了检索;我们没有对语言进行任何限制。
比较 PD 加 SLA 与 PD 加 ELA 的随机对照试验(RCT),包括胰头和壶腹周围腺癌患者。
两位综述作者独立筛选参考文献并从研究报告中提取数据。我们计算了大多数二项结局的汇总风险比(RR),除了术后死亡率,我们估计了 Peto 比值比(Peto OR),以及连续结局的平均差异(MD)。在没有明显异质性(I²<25%)的情况下,我们使用固定效应模型,在存在明显异质性(I²>25%)的情况下,我们使用随机效应模型。两位综述作者独立评估了偏倚风险,并使用 GRADE 评估了重要结局的证据质量。
我们纳入了 7 项研究,共 843 名参与者(421 名 ELA 和 422 名 SLA)。所有 7 项研究均包括了总生存率的 Kaplan-Meier 曲线。两组之间的生存率没有明显差异(对数危险比(log HR)0.12,95%置信区间(CI)-3.06 至 3.31;P=0.94;7 项研究,843 名参与者;极低质量证据)。两组之间的术后死亡率没有明显差异(Peto 比值比(OR)1.20,95%置信区间(CI)0.51 至 2.80;7 项研究,843 名参与者;低质量证据)。ELA 的手术时间可能更长(平均差异(MD)50.13 分钟,95%置信区间(CI)19.19 至 81.06 分钟;5 项研究,670 名参与者;中等质量证据)。研究之间存在很大的异质性(I²=88%;P<0.00001)。ELA 期间可能有更多的出血量(MD 137.43 毫升,95%置信区间(CI)11.55 至 263.30 毫升;2 项研究,463 名参与者;极低质量证据)。研究之间存在很大的异质性(I²=81%,P=0.02)。ELA 期间可能有更多的淋巴结检出(MD 11.09 个淋巴结,95%置信区间(CI)7.16 至 15.02;5 项研究,670 名参与者;中等质量证据)。研究之间存在很大的异质性(I²=81%,P<0.00001)。两组之间阳性切缘的发生率没有明显差异(RR 0.81,95%置信区间(CI)0.58 至 1.13;6 项研究,783 名参与者;极低质量证据)。
目前的证据既不能支持也不能反驳扩展淋巴结切除与标准淋巴结切除相比对生存的影响。然而,在扩大切除组中,手术时间可能更长,出血量可能更多。总之,目前的证据既不支持也不反对在胰头腺癌患者中进行广泛的淋巴结清扫。