权威综述|困难胆总管结石的内镜治疗进展

(本文来自www.77y77.com)

冯拥璞, 高野, 辛磊, 李兆申
上海长海医院 消化内科

(原创文章www.77y77.com)






(原创文章www.77y77.com)


胆总管结石(CBDS)是一种常见的胆道疾病,可引起腹痛、梗阻性黄疸、胆管炎和胰腺炎,甚至致命[1]。随着设备和技术的不断发展,内镜治疗已成为CBDS的首选治疗方式[2]。通过内镜下逆行胆胰管造影术(ERCP)行内镜下乳头括约肌切开术(EST)等常规方法,胆总管取石的成功率可达85%~90%,但仍有10%~15%的CBDS通过常规内镜治疗方法难以清除,这些结石被称为“困难CBDS”[3]


学术界对困难CBDS并无公认的严格定义,导致CBDS取石困难的原因主要包括3种情况:一是结石本身的特点,如结石直径>15 mm、结石嵌顿、数量多、质地硬、结石形状特殊(桶形或立方形)等;二是存在解剖结构变异,如壶腹周围憩室、Roux-en-Y胃空肠吻合、毕二式术后解剖、十二指肠狭窄、胆管狭窄、S形胆总管、胆总管远端长度过短(≤36 mm)、急性胆总管远端成角(≤135°)等;三是患者存在合并症不能耐受内镜治疗,如高龄、存在出血倾向、正在接受抗凝治疗等[4-5]。目前,针对第1种情况的困难CBDS内镜治疗方式包括内镜下乳头大球囊扩张术(EPLBD)、机械碎石术(ML)、经口胆道镜(POCS)辅助碎石和体外冲击波碎石(ESWL)等,本文就相关研究进展作一综述。








1EST联合EPLBD



EST是取出CBDS前扩大乳头开口的标准方法。内镜下乳头球囊扩张术(EPBD)指使用直径<10 mm的球囊扩张胆管括约肌的技术,对于无禁忌证的小块结石患者,EPBD可作为EST的替代疗法;EPLBD由EPBD演变而来,指使用直径>12 mm的球囊扩张胆管开口的技术,既可以与EST联合应用也可以单独使用[6-7]。为简化大块或困难结石的取出,并减少因单独行EST或EPBD导致的不良事件,2003年,Ersoz等[8]首次报道小切口EST联合EPLBD用于大块或困难结石的取出,该方法在此后得到不断发展并逐渐被认可。其综合了EST和EPLBD的优势:因对括约肌损伤较小,可降低穿孔和出血的风险;由于EST小切口分离了胆管和胰管开口,可减少胰管在胆管扩张过程中受到的损伤,降低术后胰腺炎发生率[9]。欧洲消化内镜学会推荐将小切口EST联合EPLBD作为困难结石取出的首选方法[10]。美国消化内镜学会也推荐使用EST联合EPLBD治疗较大的CBDS[11]


多项研究对比了EST联合EPLBD和单纯EST对困难CBDS的疗效及安全性。已发表的4篇[12-15]荟萃分析均认为2种疗法的总体取石成功率相同,但相较于单纯EST,EST联合EPLBD减少了30%~50%的ML比例[16-18]。关于不良事件发生率,有6项RCT认为2种疗法不良事件发生率无显著差异,1项RCT[19]认为EST联合EPLBD的不良事件发生率显著低于单纯EST。另有一篇纳入30项研究(22项回顾性研究、4项前瞻性研究和4项RCT)的系统综述[20]显示,EST联合EPLBD和单纯EST的不良事件发生率分别为8.3 %和12.7 %(P<0.001)。因此,现有研究认为EST联合EPLBD治疗困难CBDS的主要优势在于安全性更高。


近期亦有多项研究对EST联合EPLBD和单纯EPLBD处理较大CBDS的疗效及安全性进行了比较,其结论相似:2种方法在总取石成功率、总不良事件发生率和ML干预率等方面无显著差异,认为没有必要在EPLBD术前行EST[21-24]。一篇纳入7项RCT的荟萃分析[25]结果显示,2种疗法在首次治疗成功率(OR=0.69, 95%CI:0.44~1.09,P=0.11)、机械碎石率(OR=1.18, 95%CI:0.68~2.05, P=0.55)、术后胰腺炎发生率(OR=0.88, 95%CI:0.43~1.78, P=0.72)等方面无显著差异。上述几项研究对于较大CBDS的界定标准均<15 mm,另有研究[26]认为,EST联合EPLBD对较大CBDS(≥15 mm)的首次治疗成功率高于单纯EPLBD。多项研究结论不一,可能与各项研究对于较大CBDS的界定标准不同有关,因此,“较大CBDS”的界定标准有待进一步细化,细化界定标准后的大样本的临床研究也有待进一步开展。


EST联合EPLBD的总体不良事件发生率为8.3%,常见不良事件包括出血(3.6%)、胰腺炎(2.4%)和穿孔(0.6%)[20]。一项回顾性研究[27]认为,相较于较小球囊(12~15 mm),在EPLBD中使用较大球囊(>15 mm)增加了严重或致死性不良事件的发生(1.6% vs 0,P=0.020),使用直径>15 mm球囊是严重或致死性不良事件的唯一危险因素(OR=23.8)。一项回顾性研究[28]认为EST联合EPLBD手术时长与ERCP术后胰腺炎的发生独立相关。一项RCT[29]认为,放置鼻胆管引流可降低EST联合EPLBD术后发生胰腺炎的风险。








2机械碎石术(ML)



ML指利用碎石网篮套住结石,之后通过金属螺旋鞘收紧网篮压碎结石的技术,包括应急碎石术(OTS)和内镜下ML,处理困难结石一般首选内镜下ML技术,OTS技术主要适用于普通篮网取石失败且结石嵌顿的情况[10]。ML的优势包括易于普及、效果较好且费用低廉[30]。ML治疗困难CBDS的总成功率为90%~94%[31-32]。当对困难CBDS行EST联合EPLBD失败或不合适时,欧洲消化内镜学会指南推荐行ML[10]


ML的局限性在于其操作复杂、耗费时间,且可能需要多次操作[30]。为改进ML效果,有研究[33]认为,相较于在大块结石上方展开网篮,在大块结石(>20 mm)下方展开网篮可增加大块结石捕获率(33.3% vs 94.1%,P<0.05)。另有一项研究[34]认为,在对困难结石行ML前置入短期(2~3个月)胆管支架可减少手术耗时并增加网篮的持久性。近期2项研究对ML失败的相关因素进行了分析。Garg等35]认为结石嵌顿是ML失败的唯一相关因素;另一项回顾性研究[36]认为结石嵌顿、结石直径≥30 mm和结石与胆管直径比>1.0与ML失败显著相关,OR值分别为17.83、4.32和5.47。


一项多中心回顾性研究[37]分析了ML并发症的情况,ML治疗CBDS的并发症发生率为3.5%,主要的并发症包括网篮滞留、破裂、导丝断裂或手柄损坏,主要的补救措施有OTS、ESWL或POCS辅助碎石术、增加括约肌切开或置入支架。








3POCS辅助碎石术



POCS辅助碎石术指在POCS直视下通过液电碎石术(EHL)或激光碎石术(LL)的方式进行碎石,所用设备包括双人操作母子胆道镜系统、单人操作胆道镜和直接经口胆道镜(如超细内镜),3种设备均可进行EHL和LL[10]


POCS辅助碎石术可有效地处理困难CBDS。一项纳入31项研究的荟萃分析[38]显示,POCS辅助碎石术对困难CBDS的总体清除率为88%。最近,一项国际多中心回顾性研究[39]评估了单人操作胆道镜对困难CBDS的疗效,研究纳入407例患者(EHL 306例,LL 101例),总体胆管结石清除率达97.3%,不良事件发生率为3.7%。Sandha等[40]回顾性分析了51例因困难CBDS行单人操作胆管镜下LL的病例,成功率达93%,且花费少于开腹和腹腔镜胆管探查术。Buxbaum等[41]对比了POCS引导下LL和其他常规疗法(如ML或球囊扩张取石)对较大CBDS(>1 cm)的疗效,发现POCS引导下LL的大块结石内镜清除率更高(93% vs 67%,P=0.009)。一项RCT[42]比较了单人操作胆道镜引导下LL和大球囊括约肌成形术对困难CBDS的疗效,单人操作胆道镜引导下LL组治疗成功率更高(93.9% vs 72.7%,P=0.021),2组不良事件发生率无显著差异。一项RCT[43]比较了POCS引导下LL和ML对困难CBDS的疗效和安全性,32例CBDS病例在接受标准EST和/或EPLBD治疗失败后,被随机分配到POCS引导下LL组和ML组进行治疗,发现LL的结石清除率更高(100% vs 63%; P<0.01)且辐射暴露剂量更低(20 989 vs 40 745 mGycm2; P=0.04)。总体来说,对于常规处理失败后的困难CBDS,POCS辅助碎石术疗效确切,相比于传统的ML等技术具有一定的优势。


对于POCS辅助下的不同碎石技术,多数研究认为LL的疗效和安全性优于EHL。一篇系统综述[44]比较了LL和EHL对常规内镜取石失败的CBDS的疗效和安全性,LL的胆管完全清除率、结石粉碎率均高于EHL(胆管完全清除率:95.1% vs 88.4%,结石粉碎率:92.5% vs 75.5%),LL的术后并发症率也低于EHL(9.6% vs 13.8%)。一项回顾性研究[39]发现,在治疗困难CBDS时,与单人操作胆道镜EHL相比,单人操作胆道镜LL的平均手术时长更短(49.9 min vs 73.9 min,P<0.001),但两者的结石清除率无显著差异。


POCS辅助碎石术治疗困难CBDS的总体不良事件发生率为7%,最常见的不良事件为胆管炎,发生率约为4%,此外,胰腺炎、穿孔和其他不良事件发生率约为2%、1%和3%,严重不良事件发生率为1%[38]。Brewer Gutierrez等[39]对多次单人操作胆道镜碎石技术失败的相关因素进行了分析,认为解剖结构复杂或插管困难是唯一的相关因素。








4体外冲击波碎石(ESWL)



ESWL自1980年被首次应用于泌尿系结石治疗以来,其适应证不断拓展,现亦用于常规疗法难以处理的较大CBDS的治疗[45]。欧洲消化内镜学会指南推荐当常规技术无法清除CBDS且无腔内碎石技术时,可考虑行ESWL[10]。ESWL利用液电或电磁能量产生冲击波,透过人体软组织将结石震碎[46]。ESWL操作较为复杂,对技术要求高,为便于透视下识别和定位结石,需要置入鼻胆引流管,且操作期间需用造影剂或生理盐水持续注入胆管。此外,需行多次ESWL并行ERCP以清理结石。


一项纳入283例较大CBDS的前瞻性研究[47]评估了ESWL的疗效,胆总管结石清除率为84.4%,74.6%病例所需ESWL操作次数≤3次,并发症发生率为15.9%,硬膜外麻醉、90 次/min的冲击波频率、阴性结石和结石周围存有液体有助于碎石。一篇系统综述[44]比较了多种方法对常规内镜治疗失败的CBDS的治疗效果,发现ESWL的胆管完全清除率和结石粉碎率均低于LL。由于技术上的局限,ESWL治疗胆管结石目前在我国开展较少。Tao等[48]比较了ERCP术前行单次ESWL治疗对复杂和较大CBDS的疗效,单次ESWL+ERCP组(若ESWL治疗无效,则对患者行ERCP治疗)和ERCP组分别纳入124例和107例,2组除首次结石清除率和术后并发症发生率两指标相似外,单次ESWL+ERCP组在总结石清除率、减少ERCP时长,减少ML干预,提高巨大结石清除率等方面均优于ERCP组,说明单次ESWL辅助ERCP治疗复杂和大块CBDS的效果较好。杨晶等[49]比较了ESWL联合内镜治疗和ML对困难CBDS的疗效和安全性,结果显示ESWL联合内镜治疗组的碎石成功率和结石完全清除率均高于ML组,而2组在并发症发生率、住院时间和住院费用方面无显著差异。


ESWL的术后并发症率为8.4%,主要包括胆道出血(2.9%)、胆管炎(2.9%)以及胰腺炎(1.7%)[44]。Muratori等[50]分析了ESWL治疗困难CBDS后复发的危险因素,认为合并胆囊结石、胆总管直径≥11 mm和结石直径>19 mm这3个因素与复发显著相关。







5小结



术前判断结石为困难CBDS或常规内镜治疗失败后,建议首先行EST联合EPLBD,若失败或无法开展,则应综合考虑患者病情、医院硬件条件及术者经验等因素,选择ML、POCS辅助碎石术或ESWL等技术进行治疗。此外,随着腹腔镜胆总管探查术等外科手术日趋成熟,对困难病例不应仅考虑内镜治疗,部分病例应由多学科合作团队讨论共同决定手术方式。对无法取石、但需急诊解除胆管梗阻的患者,也可先行内镜下鼻胆管引流术、内镜下逆行胆管支架置入术,以及经皮肝穿胆道引流等,择期再行取石治疗。今后,期待更多高质量临床研究,针对不同情况的困难CBDS得出细化的最佳治疗方案。


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引证本文

冯拥璞, 高野, 辛磊, 李兆申. 困难胆总管结石的内镜治疗进展[J]. 临床肝胆病杂志, 2021, 37(1): 229-232.




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