Department of General Surgery, Glan Clwyd Hospital, Rhyl, Denbighshire, UK.
Department of General Surgery, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.
Langenbecks Arch Surg. 2021 May;406(3):547-561. doi: 10.1007/s00423-020-01999-5. Epub 2020 Sep 26.
To compare baseline demographics, operative, and survival outcomes of randomised controlled trials (RCTs) comparing standard lymphadenectomy versus extended lymphadenectomy in patients undergoing pancreaticoduodenectomy for pancreatic head cancer METHODS: In compliance with PRISMA standards we performed a meta-analysis of baseline demographics, operative, and survival outcomes of RCTs comparing standard lymphadenectomy versus extended lymphadenectomy in patients undergoing pancreaticoduodenectomy for pancreatic head cancer. The uncertainties associated with varying follow-up periods among the included studies were resolved by analysis of time-to-event outcomes. Moreover, we performed trial sequential analysis (TSA) to determine whether the available evidence is conclusive and to assess the risk of type 1 or type 2 errors.
Overall, 724 patients from 5 RCTs were included. The included populations were comparable in terms of baseline characteristics. There was no difference between standard and extended lymphadenectomy in terms of pancreatic fistula (OR 0.64, P = 0.11), delayed gastric emptying (OR 0.68, P = 0.40), bile leak (OR 0.33, P = 0.06), wound infection (OR 0.53, P = 0.06), abscess (OR 0.83, P = 0.63), total complications (OR 0.73, P = 0.27), postoperative mortality (OR 1.01, P = 0.85), and overall survival (HR 1.10, P = 0.46). TSA suggested that meta-analysis was conclusive with low risk of type 2 error. The results remained consistent through subgroup analyses based on lymph node positive or negative status and studies from the West and East.
Robust evidence from randomised controlled trials (Level 1) suggests no difference in postoperative and survival outcomes between standard and extended lymphadenectomy in patients undergoing pancreaticoduodenectomy for pancreatic head cancer. The findings were consistent in patients with positive and negative lymph node status and in studies from the West or East.
比较标准淋巴结清扫术与扩大淋巴结清扫术治疗胰头癌胰十二指肠切除术患者的随机对照试验（RCT）的基线人口统计学、手术和生存结果。
根据 PRISMA 标准，我们对比较标准淋巴结清扫术与扩大淋巴结清扫术治疗胰头癌胰十二指肠切除术患者的 RCT 的基线人口统计学、手术和生存结果进行了荟萃分析。通过分析时间事件结局解决了纳入研究之间随访期不同的不确定性。此外，我们进行了试验序贯分析（TSA），以确定现有证据是否具有结论性，并评估发生 I 型或 II 型错误的风险。
共有 5 项 RCT 的 724 例患者纳入研究。纳入人群在基线特征方面具有可比性。在胰瘘（OR 0.64，P = 0.11）、胃排空延迟（OR 0.68，P = 0.40）、胆漏（OR 0.33，P = 0.06）、伤口感染（OR 0.53，P = 0.06）、脓肿（OR 0.83，P = 0.63）、总并发症（OR 0.73，P = 0.27）、术后死亡率（OR 1.01，P = 0.85）和总生存（HR 1.10，P = 0.46）方面，标准和扩大淋巴结清扫术之间无差异。TSA 表明荟萃分析具有结论性，发生 II 型错误的风险较低。基于淋巴结阳性或阴性状态和东西方研究的亚组分析结果保持一致。
来自随机对照试验（一级）的有力证据表明，在胰头癌胰十二指肠切除术患者中，标准淋巴结清扫术与扩大淋巴结清扫术在术后和生存结果方面没有差异。这些发现在淋巴结阳性和阴性患者以及东西方研究中是一致的。
