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比较安全性和有效性:腹腔镜与开放胰十二指肠切除术治疗胰腺导管腺癌:一项随机对照试验的荟萃分析

Comparing Safety and Efficacy: Laparoscopic vs. Open Pancreaticoduodenectomy for Pancreatic Ductal Adenocarcinoma: A Meta-analysis of Randomized Control Trials.

作者信息

Rangwala Hussain Sohail, Fatima Hareer, Ali Mirha, Rangwala Burhanuddin Sohail

机构信息

Department of Medicine, Jinnah Sindh Medical University, Iqbal, Shaheed Rd, Karachi, Pakistan.

出版信息

Indian J Surg Oncol. 2025 Apr;16(2):432-442. doi: 10.1007/s13193-024-02132-4. Epub 2024 Nov 22.

Abstract

Pancreatic ductal adenocarcinoma (PDAC) has an estimated 5-year survival rate of 11% and remains a formidable challenge. Despite evolving pancreaticoduodenectomy techniques, the pinnacle status of laparoscopic surgery persists. Technological advancements since Gagner and Pomp's 1994 breakthrough have expanded its reach, yet it remains complex. Although safety reports exist, large-scale studies establishing the viability of laparoscopic surgery for PDAC are scarce. This study aimed to provide an up-to-date meta-analysis, scrutinizing all relevant trials, especially recently published ones, to discern differences between laparoscopic and open pancreaticoduodenectomy procedures. This meta-analysis, following the PRISMA guidelines, systematically searched the PubMed and Cochrane Library databases for randomized controlled trials on pancreaticoduodenectomy up to November 25, 2023. Data extraction, quality assessment, and statistical analysis, including primary and secondary outcomes, were conducted using rigorous methodology. The study employed Review Manager 5.4 for analysis, with significance set at  < 0.05. This meta-analysis, comprising five randomized controlled trials (laparoscopic, 605; open, 601; total, 1206), utilized the Cochrane Risk of Bias 2 tool, revealing minimal bias. Primary outcome analysis indicated a shorter hospital stay with laparoscopic pancreaticoduodenectomy (S.M.D. =  - 0.18, 95% CI - 0.63 - 0.28,  = 0.45) and reduced blood loss (S.M.D. =  - 1.96, 95% CI - 3.05, 0.88,  = 0.0004), but increased operative time (S.M.D. = 1.74, 95% CI 0.95 to 2.53,  < 0.0001). The secondary outcomes showed no significant differences in morbidity, mortality, resection, fistula, gastric emptying, hemorrhage, bile leak, reoperation, readmission, and surgical site infection between the two procedures. Laparoscopic pancreaticoduodenectomy (LPD) offers marginal benefits over open pancreaticoduodenectomy (OPD), including reduced blood loss and shorter hospital stays. However, LPD requires a significantly longer operative time, and no substantial differences have been observed in terms of mortality or other complications. Additional studies with lower heterogeneity are needed to thoroughly evaluate the comparative effectiveness and safety of LPD and OPD.

摘要

胰腺导管腺癌(PDAC)的估计5年生存率为11%,仍然是一个巨大的挑战。尽管胰十二指肠切除术技术不断发展,但腹腔镜手术的巅峰地位依然存在。自1994年加格纳(Gagner)和庞普(Pomp)取得突破以来的技术进步扩大了其应用范围,但该手术仍然复杂。虽然有安全性报告,但证实腹腔镜手术治疗PDAC可行性的大规模研究却很匮乏。本研究旨在提供一项最新的荟萃分析,仔细审查所有相关试验,尤其是最近发表的试验,以辨别腹腔镜和开放胰十二指肠切除术之间的差异。这项荟萃分析遵循PRISMA指南,系统地在PubMed和考科蓝图书馆数据库中检索截至2023年11月25日的关于胰十二指肠切除术的随机对照试验。使用严格的方法进行数据提取、质量评估和统计分析,包括主要和次要结局。该研究采用Review Manager 5.4进行分析,显著性设定为<0.05。这项荟萃分析纳入了五项随机对照试验(腹腔镜组605例;开放组601例;共1206例),使用考科蓝偏倚风险2工具,显示偏倚极小。主要结局分析表明,腹腔镜胰十二指肠切除术的住院时间较短(标准化均数差[S.M.D.]=-0.18,95%置信区间[-0.63,-0.28],P=0.45),失血减少(S.M.D.=-1.96,95%置信区间[-3.05,-0.88],P=0.0004),但手术时间延长(S.M.D.=1.74,95%置信区间0.95至2.53,P<0.0001)。次要结局显示,两种手术在发病率、死亡率、切除情况、瘘、胃排空、出血、胆漏、再次手术、再次入院和手术部位感染方面无显著差异。腹腔镜胰十二指肠切除术(LPD)与开放胰十二指肠切除术(OPD)相比有一些微小优势,包括失血减少和住院时间缩短。然而,LPD需要显著更长的手术时间,在死亡率或其他并发症方面未观察到实质性差异。需要开展更多异质性较低的研究,以全面评估LPD和OPD的相对有效性和安全性。

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