扩大肝切除与局限肝切除治疗Ⅲ、Ⅳ型肝门部胆管癌有效性和安全性的Meta分析

Efficacy and safety of extended hepatectomy versus limited hepatectomy for type Ⅲ and Ⅳ hilar cholangiocarcinoma:a Meta-analysis

背景与目的:肝门部胆管癌(HC)是临床上最常见的肝外胆管癌,其恶性程度高,预后较差,根治性切除仍是HC患者获得长期生存的最有效手段。Ⅲ、Ⅳ型(Bismuth-Corlette分型)HC病变复杂,手术难度大,危险程度高。通过局限肝切除手术风险相对低,但可能导致更高的切缘阳性率,从而影响预后,而扩大肝切除可以提高根治性切除率和生存率,但也增加了手术风险,因此,目前Ⅲ、Ⅳ型HC的肝切除范围尚无统一意见。本研究通过使用Meta分析的方法评价扩大肝切除和局限肝切除治疗Ⅲ、Ⅳ型HC的疗效和安全性,以期获得循证医学证据为临床提供参考。方法:检索多个国内外文献数据库,收集研究对象为比较扩大肝切除和局限肝切除治疗Ⅲ、Ⅳ型HC的临床对照研究文献,检索时间为各数据库自建库截至2022年11月30日。由两名研究者按照纳入和排除标准,独立筛选文献并提取数据,运用RevMan 5.2软件进行Meta分析。结果:共纳入11篇文献,844例Ⅲ、Ⅳ型HC患者;其中扩大肝切除组423例,局限肝切除组421例。Meta分析结果显示,与局限肝切除组比较,扩大肝切除组根治性切除率明显提高(OR=4.44,95%CI=2.65~7.45,P<0.00001),临床预后更好(HR=0.53,95%CI=0.41~0.68,P<0.00001);扩大肝切除组术后肝功能衰竭发生率升高(OR=3.00,95%CI=1.07~8.40,P=0.04),但术后死亡发生率(OR=1.12,95%CI=0.25~4.99,P=0.88)、术后总并发症发生率(OR=1.44,95%CI=0.95~2.18,P=0.09)及术后其他单个并发症发生率差异均无统计学意义(胆汁漏:OR=1.44,95%CI=0.68~3.04,P=0.34;腹腔出血:OR=0.77,95%CI=0.29~2.05,P=0.60;腹腔感染:OR=1.36,95%CI=0.50~3.71,P=0.55)。此外,与局限肝切除组比较,扩大肝切除组术中出血量、手术时间、住院时间均明显增加(MD=153.48,95%CI=32.63~274.33,P=0.01;MD=78.19,95%CI=54.56~101.82,P<0.00001;MD=2.55,95%CI=1.61~3.50,P<0.00001)。结论:扩大肝切除术可以提高Ⅲ、Ⅳ型HC的根治性切除率,明显改善预后,并未增加术后死亡和总体并发症发生率,但术后肝功能衰竭发生率升高。鉴于研究的局限性,仍需更多前瞻性随机对照研究进一步证实。

Background and aims:Hilar cholangiocarcinoma(HC)is the most common form of extrahepatic cholangiocarcinoma in clinical practice.It is highly malignant and associated with a poor prognosis.Radical resection remains the most effective approach for achieving long-term survival in HC patients.TypeⅢandⅣ(Bismuth-Corlette classification)HC lesions are complex,with serious surgical difficulty and risk.Surgery by limited hepatectomy carries relatively low risk but may result in a higher rate of positive margins,which may affect prognosis.Conversely,extended hepatectomy may improve radical rates and survival and increase surgical risks.There is yet to be a consensus on the appropriate scope of hepatectomy for typeⅢandⅣHC.This study evaluated the efficacy and safety of extended hepatectomy and limited hepatectomy for typeⅢandⅣHC by a Meta-analysis to provide evidencebased guidance for clinical decision-making.Methods:The clinical control studies comparing extended hepatectomy and limited hepatectomy for typeⅢandⅣHC were collected by searching several domestic and foreign literature databases,with a time restriction from inception to November 30,2022.Two researchers independently screened the literature and extracted data according to inclusion and exclusion criteria,and Meta-analysis was performed using RevMan 5.2 software.Results:A total of 11 articles involving 844 patients with typeⅢorⅣHC were included in the study,with 423 patients in the extended hepatectomy group and 421 patients in the limited hepatectomy group.The Meta-analysis results showed that compared to the limited hepatectomy group,the extended hepatectomy group had significantly higher radical rates(OR=4.44,95%CI=2.65-7.45,P<0.00001)and better clinical prognosis(HR=0.53,95%CI=0.41-0.68,P<0.00001).The extended hepatectomy group had a higher incidence of postoperative liver dysfunction(OR=3.00,95%CI=1.07-8.40,P=0.04),but there were no statistically significant differences in postoperative mortality rate(OR=1.12,95%CI=0.25-4.99,P=0.88),and incidence rates of overall complications(OR=1.44,95%CI=0.95-2.18,P=0.09)and other individual complications(bile leakage:OR=1.44,95%CI=0.68-3.04,P=0.34;abdominal bleeding:OR=0.77,95%CI=0.29-2.05,P=0.60;abdominal infection:OR=1.36,95%CI=0.50-3.71,P=0.55).Additionally,the extended hepatectomy group had significantly increased intraoperative blood loss,operative time,and hospitalization duration compared to the limited hepatectomy group(MD=153.48,95%CI=32.63-274.33,P=0.01;MD=78.19,95%CI=54.56-101.82,P<0.00001;MD=2.55,95%CI=1.61-3.50,P<0.00001).Conclusion:Extended hepatectomy can improve the radical resection rate and significantly enhance the prognosis for stageⅢandⅣHC.Moreover,it does not increase postoperative mortality or overall complication rates.However,an elevated risk of postoperative liver failure is associated with extended hepatectomy.Given the limitations of this study,further prospective randomized controlled trials are still needed to provide additional verification.