腹腔镜胆总管探查联合鼻胆管引流与T管引流术治疗胆总管结石临床疗效的Meta分析

Clinical efficacy of laparoscopic common bile duct exploration combined with endoscopic nasobiliary drainage versus T-tube drainage in the treatment of choledocholithiasis: a Meta analysis

    摘要
  • 摘要: 目的:系统评价腹腔镜胆总管探查术(LCBDE)联合鼻胆管引流与T管引流治疗胆总管结石的临床疗效。
    方法:以胆总管结石病、胆总管结石、T管引流、T管、鼻胆管引流、经内镜鼻胆管引流术、ENBD管、ENBD引流，cholelithiasis，common bile duct stone，jaundice，obstructive，Jaundice，gallstone，T-tube drainage，T-tube，t-tube，biliary tract drainge，drainge tube，endoscopic nasobiliary drainage，nasobiliary drainage，nasobiliary tube，endoscopic drainage tubes，endoscopic drainage tube，endoscopic retrograde biliary drainage为检索词，检索PubMed、Medline、Embase、the Cochrane Library、Web of Science、万方数据库、中国期刊全文数据库、中国生物医学文献数据库。检索时间为1960年1月至2019年5月。纳入比较胆总管结石腹腔镜治疗过程中留置鼻胆管与T管引流的随机对照试验(RCT)及高质量非随机对照试验(NRCT)。LCBDE联合术前、术中行鼻胆管引流术设为鼻胆管引流组，LCBDE联合术后行T管引流术设为T管引流组。结局指标：手术时间、术中出血量、术后住院时间、带管时间、术后胃肠道功能恢复时间、治疗费用、手术失败率、术后胆瘘发生率、术后切口感染发生率、术后结石残留率、术后胰腺炎发生率、术后高淀粉酶血症发生率、术后胆汁性腹膜炎发生率。计数资料采用优势比(OR)及其95%可信区间(95%CI)表示，计量资料采用均数差(MD)及其95%CI表示。采用I2和Q检验分析纳入文献异质性，若I2≤50%或P>0.10时，认为无异质性，采用固定效应模型分析；若I2>50%且P≤0.10时，认为存在异质性，采用随机效应模型分析。分析计量资料时，纳入RCT>4篇，进行亚组分析。纳入RCT≤4篇，同时分析NRCT。分析计数资料时，RCT与NRCT合并分析。纳入研究≥10篇，采用漏斗图检验潜在发表偏倚，纳入研究<10篇则不检验。
    结果: (1)文献检索结果：最终纳入符合标准的相关研究共26篇，包括9篇RCT，4篇半随机化研究和13篇病例对照研究。半随机化研究和病例对照研究纳入NRCT。累计样本量2 098例，其中鼻胆管引流组1 114例，T管引流组984例。(2)Meta分析结果。①术后住院时间：鼻胆管引流组患者术后住院时间与T管引流组比较，差异有统计学意义(MD=-6.53，95%CI为-8.64~-4.43，P<0.05)，9篇RCT进一步亚组分析，无胆总管结石急性并发症鼻胆管引流组患者住院时间与T管引流组比较，差异有统计学意义(MD=-5.88，95%CI为 -8.32~-3.45，P<0.05)；伴胆总管结石急性并发症鼻胆管引流组患者住院时间与T管引流组比较，差异有统计学意义(MD=-8.77，95%CI为-12.39~-5.15，P<0.05)。②带管时间：RCT中鼻胆管引流组患者术后带管时间与T管引流组比较，差异有统计学意义(MD=-46.01，95%CI为-83.64~-8.37，P<0.05)；NRCT中鼻胆管引流组患者术后带管时间与T管引流组比较，差异有统计学意义(MD=-24.05，95%CI为-32.93~-15.18，P<0.05)。③术后胃肠道功能恢复时间：RCT中鼻胆管引流组患者术后胃肠道功能恢复时间与 T管引流组比较，差异有统计学意义(MD=-17.80，95%CI为-31.11~-4.48，P<0.05)；NRCT中鼻胆管引流组患者术后胃肠道功能恢复时间与T管引流组比较，差异有统计学意义(MD=-5.64，95%CI为-10.16~ -1.12，P<0.05)。④术后胆瘘发生率：鼻胆管引流组患者术后胆瘘发生率与T管引流组比较，差异有统计学意义(OR=0.50，95%CI为0.28~0.89，P<0.05)。⑤术后切口感染发生率：鼻胆管引流组患者术后切口感染发生率与T管引流组比较，差异有统计学意义(OR=0.35，95%CI为0.17~0.73，P<0.05)。(3)发表偏倚分析。对鼻胆管引流与T管引流治疗胆总管结石术后胆瘘发生率比较的Meta分析15篇纳入文献发表偏倚采用漏斗图检验结果显示：以术后胆瘘发生率为指标进行漏斗图分析，各点大致分布在倒置漏斗内，对称性尚可，发表偏倚对Meta分析结果影响较小。
    结论:对于内镜不能取石，LCBDE联合鼻胆管引流与联合T管引流比较，前者可缩短术后住院时间、带管时间、术后胃肠道功能恢复时间，降低术后胆瘘、术后切口感染发生率。

     

    Abstract: Objective:To systematically evaluate the clinical efficacy of laparoscopic common bile duct exploration (LCBDE) combined with endoscopic nasobiliary drainage (ENBD) versus T-tube drainage in the treatment of choledocholithiasis.
    Methods:Databases including PubMed(Medline), Embase, the Cochrane Library, Web of Science, Wanfang, CNKI and CBM were searched for literatures from January 1960 to May 2019 with the key words including “胆总管结石病, 胆总管结石; T管引流, T管; 鼻胆管引流, 经内镜鼻胆管引流术, ENBD管, ENBD引流; cholelithiasis, common bile duct stone, jaundice, obstructive, Jaundice, gallstone; T-tube drainage, T-tube, t-tube, biliary tract drainge, drainge tube; endoscopic nasobiliary drainage, nasobiliary drainage, nasobiliary tube, endoscopic drainage tubes, endoscopic drainage tube, endoscopic retrograde biliary drainage”. The randomized controlled trials (RCTs) and high quality non-randomized controlled trials (NRCTs) on comparing ENBD and T-tube drainage during laparoscopic choledocholithotomy were included.Patients who received LCBDE combined with preoperative or intraoperative ENBD were allocated into ENBD group, and patients who received LCBDE combined with postoperative T-tube drainage were allocated into T-tube drainage group. Reported outcomes: operation time, volume of intraoperative blood loss, duration of postoperative hospital stay, time to drainage tube removal, time to postoperative gastrointestinal function recovery, treatment expenses,rate of surgical failure, incidence of postoperative biliary fistula, incidence of postoperative incisional infection, incidence of postoperative residual stones, incidence of postoperative pancreatitis, incidence of postoperative hyperamylasemia, incidence of postoperative bile peritonitis. Count data were represented as odds ratio (OR) and 95% confidence interval (95%CI). Measurement data were represented as mean difference (MD) and 95%CI. The I2 and Q tests were used to analyze literature heterogeneity. I2≤50% or P>0.10 indicated no significant heterogeneity, so fixed effects model was used for Meta analysis. I2>50% and P≤0.10 indicated a significant heterogeneity, so random effects model was used for Meta analysis. When analyzing the measurement data, subgroup analysis of individual indicators was performed if there were more than 4 RCTs included, and NRCTs were analyzed for supplement if there were no more than 4 RCTs included. When analyzing the count data, RCTs and NRCTs were combined for analysis. Funnel plots were used to test potential publication bias if there were more than or equal to 10 studies included, while no test was needed if there were less than 10 studies included.
    Results:(1) Document retrival: 26 literatures meeting the standards were included, including 9 RCTs and 17 NRCTs (4 semi-randomized studies and 13 case-control studies). There were 2 098 patients, including 1 114 patients in the ENBD group and 984 patients in the T-tube drainage group. (2) Results of Meta analysis. ① Duration of postoperative hospital stay: there was a significant difference in the duration of postoperative hospital stay between the ENBD group and T-tube drainage group (MD=-6.53, 95%CI: -8.64 to -4.43，P<0.05). Further analysis of 9 RCTs showed significant differences in the duration of postoperative hospital stay between patients without acute complications of choledocholithiasis in the ENBD group and those in the T-tube drainage group, between patients with acute complications of choledocholithiasis in the ENBD group and T-tube drainage group, respectively (MD=-5.88, -8.77, 95%CI: -8.32 to -3.45, -12.39 to -5.15, P<0.05). ② Time to drainage tube removal: for the RCTs, there was a significant difference in the time to drainage tube removal between the ENBD group and T-tube drainage group (MD=-46.01, 95%CI: -83.64 to -8.37, P<0.05). For the NRCTs, there was a significant difference in the time to drainage tube removal between the ENBD group and T-tube drainage group (MD=-24.05, 95%CI: -32.93 to -15.18, P<0.05). ③ Time to postoperative gastrointestinal function recovery:for the RCTs, there was a significant difference in the time to postoperative gastrointestinal function recovery between the ENBD group and T-tube drainage group (MD=17.80, 95%CI: -31.11 to -4.48, P<0.05). For the NRCTs, there was a significant difference in the time to drainage tube removal between the ENBD group and T-tube drainage group (MD=-5.64, 95%CI: -10.16 to -1.12, P<0.05). ④ Incidence of postoperative biliary fistula: there was a significant difference in the incidence of postoperative biliary fistula between the ENBD group and T-tube drainage group (OR=0.50, 95%CI: 0.28-0.89, P<0.05). ⑤ Incidence of postoperative incisional infection: there was a significant difference in the incidence of postoperative incisional infection between the ENBD group and T-tube drainage group (OR=0.35, 95%CI: 0.17-0.73, P<0.05). (3) Analysis of publication bias. The incidence of postoperative biliary fistula in the two groups was analyzed by funnel plot based on the 15 studies. The bilateral symmetry was presented in the funnel plot for incidence of postoperative biliary fistula, suggesting that publication bias had little influence on results of Meta analysis.
    Conclusion:For patients with choledocholithiasis that endoscopic lithotomy is not feasible, LCBDE combined with ENBD can significantly shorten duration of postoperative hospital stay, time to drainage tube removal, postoperative gastrointestinal function recovery time, reduce the incidence of postoperative biliary fistula and incisional infection compared with LCBDE combined with T-tube drainage.

     

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