Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, Heidelberg, Germany.
Ann Surg. 2020 Jan;271(1):54-66. doi: 10.1097/SLA.0000000000003309.
To compare perioperative outcomes of laparoscopic pancreaticoduodenectomy (LPD) to open pancreaticoduodenectomy (OPD) using evidence from randomized controlled trials (RCTs).
LPD is used more commonly, but this surge is mostly based on observational data.
We searched CENTRAL, Medline and Web of Science for RCTs comparing minimally invasive to OPD for adults with benign or malignant disease requiring elective pancreaticoduodenectomy. Main outcomes were 90-day mortality, Clavien-Dindo ≥3 complications, and length of hospital stay (LOS). Secondary outcomes were postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), postpancreatectomy hemorrhage (PPH), bile leak, blood loss, reoperation, readmission, oncologic outcomes (R0-resection, lymph nodes harvested), and operative times. Data were pooled as odds ratio (OR) or mean difference (MD) with a random-effects model. Risk of bias was assessed using the Cochrane Tool and the GRADE approach (Prospero registration ID: CRD42019120363).
Three RCTs with a total of 224 patients were included. Meta-analysis showed there were no significant differences regarding 90-day mortality, Clavien-Dindo ≥3 complications, LOS, POPF, DGE, PPH, bile leak, reoperation, readmission, or oncologic outcomes between LPD and OPD. Operative times were significantly longer for LPD {MD [95% confidence interval (CI)] 95.44 minutes (24.06-166.81 minutes)}, whereas blood loss was lower for LPD [MD (CI) -150.99 mL (-168.54 to -133.44 mL)]. Certainty of evidence was moderate to very low.
At current level of evidence, LPD shows no advantage over OPD. Limitations include high risk of bias and moderate to very low certainty of evidence. Further studies should focus on patient safety during LPD learning curves and the potential role of robotic surgery.
通过随机对照试验（RCT）的证据，比较腹腔镜胰十二指肠切除术（LPD）与开腹胰十二指肠切除术（OPD）的围手术期结果。
LPD 的应用更为普遍，但这种激增主要基于观察性数据。
我们在 CENTRAL、Medline 和 Web of Science 中检索了比较微创与 OPD 治疗需要择期胰十二指肠切除术的成人良性或恶性疾病的 RCT。主要结局为 90 天死亡率、Clavien-Dindo ≥3 级并发症和住院时间（LOS）。次要结局为术后胰瘘（POPF）、延迟性胃排空（DGE）、胰切除术后出血（PPH）、胆漏、出血量、再次手术、再次入院、肿瘤学结局（R0 切除、淋巴结清扫）和手术时间。数据以比值比（OR）或均数差（MD）进行汇总，并采用随机效应模型。使用 Cochrane 工具和 GRADE 方法（Prospéro 注册号：CRD42019120363）评估偏倚风险。
共纳入 3 项 RCT，总计 224 例患者。Meta 分析显示，LPD 与 OPD 之间在 90 天死亡率、Clavien-Dindo ≥3 级并发症、LOS、POPF、DGE、PPH、胆漏、再次手术、再次入院或肿瘤学结局方面无显著差异。LPD 的手术时间明显长于 OPD[MD（95%置信区间[CI]）95.44 分钟（24.06-166.81 分钟）]，而 LPD 的出血量低于 OPD[MD（CI）-150.99 毫升（-168.54 毫升至-133.44 毫升）]。证据确定性为中等到极低。
在目前的证据水平上，LPD 并不优于 OPD。局限性包括高偏倚风险和中等到极低的证据确定性。进一步的研究应关注 LPD 学习曲线期间的患者安全性和机器人手术的潜在作用。
