困难胆总管巨大结石的内镜下治疗
Endoscopic Treatment of Difficult Larger Common Bile Duct Stones
DOI: 10.12677/ACM.2022.12121729, PDF, HTML, XML, 下载: 296  浏览: 450 
作者: 赵 帅, 崔紫烟:青海大学附属医院肝胆胰外科,青海 西宁;青海大学研究生院,青海 西宁;任 利*:青海大学附属医院肝胆胰外科,青海 西宁
关键词: 胆总管结石病困难胆总管巨大结石内镜技术未清除因素Choledocholithiasis Difficult Larger CBDSs Endoscopy Unclear Factors
摘要: 胆总管结石是临床上的一种常见病,首选内镜治疗,困难胆总管巨大结石(直径 > 15 mm)难以通过常规内镜方式清除,需要内镜下乳头大球囊扩张术、机械碎石术、胆道镜辅助碎石、体外冲击波碎石和胆道支架植入术等介入治疗。现就这些手术方式的临床疗效、不良事件及结石未清除相关因素等作一综述。
Abstract: Common bile duct stones (CBDSs) are a common disease, and endoscopic therapy is the first-line treatment modality for this disease; However, difficult larger CBDSs (diameter > 15 mm) are diffi-cult to be removed by conventional endoscopic modalities, requiring endoscopic papillary large balloon dilation (EPLBD), mechanical lithotripsy (ML), cholangioscopy-assisted lithotripsy, extra-corporeal shock wave lithotripsy (ESWL), and biliary stenting interventions. We reviewed the clinical efficacy, adverse events in the above mentioned techniques for the treatment of difficult large CBDSs and factors associated with stones non-removal.
文章引用:赵帅, 任利, 崔紫烟. 困难胆总管巨大结石的内镜下治疗[J]. 临床医学进展, 2022, 12(12): 12000-12007. https://doi.org/10.12677/ACM.2022.12121729

1. 引言

胆总管结石(common bile duct stones, CBDSs)是临床上的一种常见疾病,其并发症包括梗阻性黄疸、胆管炎、肝脓肿、胰腺炎和继发性胆汁性肝硬化等,无论有无症状,均应及时治疗 [1]。内镜技术是首选治疗方式,常规措施可清除大部分结石,但整体仍有10%~15%失败率——这部分结石称为困难胆总管结石 [2] [3]。影响取石失败的因素繁多,结石直径较大是失败的一重要因素,常规内镜取石成功率随结石直径增大而减小,尤其是当结石直径大于15 mm时,取石成功率已明显下降 [2] [4] [5] [6]。对于这部分困难胆总管巨大结石,常规的内镜下手术方式,如内镜下乳头括约肌切开术(EST, endoscopic sphincterotomy)或内镜下乳头球囊扩张术(EPBD, endoscopic papillaryballoon dilation)难以取得满意结果,需要使用内镜下乳头大球囊扩张术(endoscopic papillary large balloon dilation, EPLBD)、机械碎石术(mechanical lithotripsy, ML)、(cholangioscopy-assisted lithotripsy)、体外冲击波碎石(extracorporeal shock wave lithotripsy, ESWL)、胆道支架(biliary stenting)等方式。现就困难胆总管巨大结石(>15 mm)的内镜治疗过程中,这些技术的选择顺序、临床疗效、不良事件及结石未清除相关因素等作一综述。

2. 内镜下乳头大球囊扩张术

Staritz等人 [7],于1983年将EPBD作为替代EST治疗中小型CBDS的方法引入。但在面对较大直径CBDS (>15 mm)和狭窄的远端胆管时,这些处理措施也已很难将胆管结石完全清除,EST联合EPLBD于2003年推出,以处理此类CBDS [8]。EPLBD是一种目前广泛使用的技术(一般在EST后进行),在插管成功后,将一个较大的球囊置于胆管口金属丝上,然后对胆管口进行连续扩张,直到达到所需大小,可使用的球囊的直径为12~20 mm [9]。仅EPLBD也有使用,因其省略了切割乳头过程,出血及穿孔风险较低,但传统意义上部分专家认为这会使胰腺炎等并发症 [10] 的发生率升高。在乳头切开的患者中进行球囊扩张,能使扩张朝着切口方向,而不是以圆的方式进行,从而减少对胰管的压迫,理论上可以减少机会性胰腺炎的出现 [11]。然而近期的来自东方与西方的研究显示,仅EPLBD也是安全有效的,这些研究所报道的并发症大部分都很轻微,只有很少数严重情况 [12] [13] [14] [15]。一家来自韩国的医学院对术后胰腺炎的发生率进行了统计,结果显示EPLBD和EST的胰腺炎发生率无差异 [16] (5.0%比7.0%)。一项纳入了7项随机对照试验,790例患者的关于Meta分析结果显示,EPLBD和EST术后胰腺炎、胆管穿孔发生率差异并无统计学意义 [17]。可见在正常解剖结构下,EPLBD不联合EST治疗较大CBDS是安全有效的,不会增加胰腺炎的风险。关于EPLBD的国际共识表明,在进行大直径球囊(>12 mm)扩张胆管口前,可以行EST或也可以不行EST [9]。但不管怎样,EPLBD并不是适用于所有的直径较大的CBDS,胆管狭窄是其禁忌症 [9],并且随着远端CBD逐渐变细,穿孔的风险逐渐增加。

内镜下清除胆管结石,难题之一就是扩大乳头口,目前有三种技术可以在胆管插管成功后扩大乳头开口:仅EST;初始EST后行EPLBD;仅EPLBD而无EST [18]。

Park等人 [19] 比较了EPLBD与EST + EPLBD治疗较大胆总管结石的安全性和疗效,以及不良事件的发生率,结果发现两组并无显著差异。在EST + EPLBD的基础上,出现了小切口EST联合EPLBD,这种技术保留了球囊扩张时切割方向的径向力转向胆管而不是胰管,减少了机会性胰腺炎的出现,由于切口减小还降低了出血的风险 [1] [20]。一项纳入156名患者的临床随机对照实验 [21],将患者随机分为EST组与ESBD组。EST组的患者仅接受完全的括约肌切开术;ESBD组的患者先接受小EST,然后行球囊扩张术。结果显示,虽然两组之间的结石清除百分比无显著差异(EST vs ESBD: 88.5% vs 89.0%)。但EST组(46.2%)比ESBD组(28.8%)需要更多的机械碎石术,特别是对于≥15 mm的结石(90.9% vs 58.1%; P = 0.02)。EPLBD的国际共识指南 [9] 亦认为EST + EPLBD与仅EST先比,其胆管清除率与不良事件发生率相当,但EPLBD的使用降低了碎石术的需求。

无论怎样,出血都是EST术较为严重的并发症,针刀括约肌切开术的使用和切割速度是出血发生的独立危险因素,一旦发生出血,其严重程度与术中受到的牵拉、病变(结石或癌症)或凝血障碍的影响 [22]。Kogure等人 [23] 认为如果可以在EPLBD前省略EST,对于降低出血风险和降低成本无疑是有益的,并以此较仅EPLBD与仅EST在去除胆管结石方面的疗效和安全性。结果显示与仅EST相比,仅EPLBD用于内窥镜治疗大CBD结石的单次完全结石去除率较高,并且没有增加不良事件。

球囊扩张时间是另一术中需要关注的重要问题,戴伟杰等人 [24] 研究乳头球囊扩张时间长短对困难胆总管结石取石的成功率及术后并发症的影响,该研究纳入了48例患者,并随机分为短时气囊组(1 min)与长时气囊组(3 min)。术后分析显示,长时气囊组在手术成功率、取石时间、术中并发症、术后胰腺炎发生率上均明显优于短时气囊组。另一项 [25] 针对乳头气囊扩张时间对胆总管结石取石成功率及术后并发症影响的研究认为,长时扩张与短时扩张相比(5 min vs 1 min)可以降低胰腺炎的发生率,并有更好的结石清除效果。

ESGE推荐小切口EST + EPLBD作为去除难治性胆总管结石(包括较大胆总管结石)的一线方法(强烈推荐,高质量证据) [1]。面对出血风险较高的胆总管大结石患者,仅EPLBD更适合这类患者 [12] [17],且近期的来自东方与西方的研究显示,EPLBD联合EST与仅EPLBD无任何严重不良事件的额外风险 [12] - [17],但目前尚缺乏高质量多中心临床研究,其疗效仍需进一步证实。

3. 机械碎石术

1982年,ML首次被用于清除胆管结石 [26]。ML是指使用机械碎石器破碎结石,促进结石从胆道中取出。机械碎石器包括一个加固的钢丝篮子,用来抓取进入胆管的结石,一个金属鞘和一个手柄,通过这个手柄,夹着结石的篮子向金属鞘缩回,从而施加一个粉碎力,使结石碎裂。

早期关于ML的研究 [27],认为结石大小是碎石失败的唯一预测因子,小于10 mm的结石碎石成功率在90%以上,大于28 mm的成功率68%以上。Grag等人 [28] 认为,结石大小对于机械碎石术并不是一个重要因素,除非与胆管直径一起考虑,单独的尺寸可能并不重要。即使结石非常大,只要胆管(BD)明显扩张,结石与导管壁之间有足够的空间,抓住与粉碎结石并不困难;而如果BD没有充分扩张,无法充分容纳较大的结石,则会发生嵌顿,从而影响机械碎石术的成功。所以,准确说结石嵌顿才是胆管碎石失败的唯一预测因素 [28]。Lee等人 [29] 具体研究了结石大小与胆管直径的关系,发现结石嵌塞、结石直径(≥30 mm)、结石直径与胆管直径比(>1.0)是内镜机械碎石失败的重要预测因素,估计优势比分别为17.83、4.32和5.47。有些胆红素钙结石体积很大,但硬度普遍较软,有时甚至可用标准Dormia篮直接粉碎,钙化结石与胆固醇结石质地较硬质硬,标准Dormia篮的可能无法直接粉碎 [30] [31]。

与ML相关的不良事件(AE)发生率在1.4%~14.3%,包括胆管炎、胰腺炎和出血等,其中ML术后发生胰腺炎和出血的概率并不大于EST [32] [33]。Thomas等人 [34] 对术中因器械嵌塞与损坏所发生的并发症进行了总结,胆道内相关并发症发生率高达3.6%,最常见的是篮子被困或破损(1.7%)、钢丝断裂(1.2%)、手柄断裂(1.1%)和穿孔/导管损伤(0.5%)。

ESGE建议,当小切口EST + EPLBD失败后或者不适合使用时,可行ML (强烈建议,中等质量的证据) [1]。机械碎石术设备简单、廉价,不需要多余设备,且取石效果良好,是治疗EPLBD术后无法取出的CBD良好选择 [33] [35]。影响碎石成功率的原因繁多,部分患者可能需要多次碎石。

4. 胆道镜辅助碎石术

胆道镜辅助碎石术依照碎石原理可以分为液电碎石术(Electrohydraulic lithotripsy, EHL)和激光碎石术(intracorporeal laser lithotripsy, ILL),均需在直视下进行操作,以避免损伤导管壁。EHL是一种依赖高频液压波进行碎石的技术,这股能量在施加电荷时产生,在被结石吸收后促进结石裂解;ILL将特定波长的激光聚焦在石头表面,以引起波介导的结石碎裂 [36]。

胆道镜经历二十多年的发展,目前有3种经口胆道镜检查技术:① 双人操作子母胆道镜系统,需要两位操作员,一位操作员操作十二指肠镜,另一位操作员操作胆道镜;② SpyGlass单人操作胆道镜系统,这项技术将胆道镜连接到十二指肠镜,允许一名操作员进行单人操控,管理两个范围的控制;③ 直接经口胆道镜(超细内镜或细胃镜),使用超薄内窥镜直接进行胆管镜检查。单操作员胆道镜系统(Single-operator cholangioscopy system, SOC) (SpyGlass; Boston Scientific, Natick, Mass)由于光纤成像欠佳,并没有得到充分使用 [37]。数字单操作员胆道镜系统(Digital single-operator cholangioscopy system, D-SOC) (SpyGlass DS; Boston Scientific)成功解决了图像质量不佳的问题,这促进了胆道镜在临床上的应用 [38]。

一项纳入了35项研究 [39] 的荟萃分析(n = 1762)显示,经口胆道镜(POC)胆管内碎石术的整体结石清除成功率为91.22% (95% CI 88.14~93.56; I2 = 63.16%),平均进行1.32 ± 0.62次碎石术。单次碎片成功率为76.86% (95% CI 71.55~81.44; I2 = 74.33%),不良事件发生率为8.94% (95% CI 6.50~12.17; I2 = 60.66%),平均手术时间为68.32 ± 20.99分钟。EHL与ILL总体碎片率或不良事件没有差异;与EHL相比,ILL单次碎石成功率较高、手术时间更短。另一项纳入了24项研究的荟萃分析(n = 2786)显示,整体结石清除率为94.3% (95% CI: 90.2%~97.5%),不良事件发生率为6.1% (95% CI: 3.8%~8.7%) [40]。

内镜下扩张胆管口所使用的大球囊尺寸范围在12~20 mm,然而,为了减少严重事件,更经常使用 ≤ 15 mm的球囊 [9] [41]。因此,当存在胆管远端明显狭窄或结石大于球囊大小等情况时,EPLBD难以发挥良好作用,这就需要胆道镜下碎石术的进一步处理。一项纳入了32名患者的研究 [42],在这项研究中所纳入的患者均符合:结石较大或者存在胆管远端狭窄的条件,在标准EST和/或EPLBD取石失败后,被随机分配进行ML或ILL。ML与ILL相比,ML组首次结石清除率较低(63% vs 100%; P < 0.01),ILL组均在首次治疗内实现了结石清除,并且ILL补救了60%的ML取石失败的患者。ML组患者的辐射暴露显着高于ILL组(40,745 vs 20,989 mGy cm2; P = 0.04),两组不良事件(13% vs 6%; P = 0.76)与住院时间(1天vs 1天;P = 0.27)没有差异。总而言之,Angsuwatcharakon等人认为,虽然ML是EPLBD失败治疗较大的CBDS的标准术式,但在设备允许的情况下,胆道镜碎石术是更好选择。

Bokemeyer等人 [43] 将胆道镜引导下的ILL与EHL进行了比较,结果显示ILL和EHL结石的清除成功率相似(66% vs 68%; P = 0.87)。部分胆道镜处理过程(约16%)中出现了并发症,主要为胆管炎和胰腺炎,然而,除1例外,所有的均为轻度或中度,无术后死亡。

胆道镜辅助碎石术在治疗困难胆管结石方面越来越受欢迎,因为它可以在治疗过程中直接观察结石以将其碎裂。但胆道镜辅助碎石设备较为昂贵,且易损伤胆管,且要求术者有良好的专业知识,尽管如此,当常规方法失败时,胆道镜辅助碎石术仍一种有效且安全的选择,但仍需要更多的随机对照试验来进一步证实疗效。

5. 体外冲击波碎石术

Chaussy等人 [44] 于1980年首次描述了用于碎裂肾结石和输尿管结石的ESWL技术。此后,八十年代中期 [45],ESWL开始用于清除常规方法不能清除的胆管结石。ESWL是一种使用液电或电磁能量来破碎CBDS的技术,术前需插入鼻胆管引流管来在透视下识别与定位胆管结石 [46]。术后需再次行胆管造影,如发现结石残留可再次行ESWL,或行ERCP术去除残留碎石,ESWL后行ERCP,不仅可以清除残留碎石,还有胆道内减压的作用 [47]。该技术影响结石清除失败的主要因素有:结石较大、结石嵌顿和存在胆管炎等,这些患者也可能要面对多次碎石或碎石失败得风险 [46]。

因为有较高的碎石成功率和较小的并发症,在ERCP之前的行ESWL似乎成为了替代内窥镜去除困难CBDS的一种安全且有效的方法。Tao等人 [47] 比较了ESWL + ERCP与仅ERCP对困难CBDS的疗效。结果发现,ESWL + ERCP组与仅ERCP组相比,总体结石清除率更优(96.0% vs 86.0%, P = 0.029)。此外,ESWL + ERCP组不仅减少了ERCP手术时间(43 ± 21 min vs 59 ± 28 min, P = 0.034)和机械碎石的使用率(20% vs 30%, P = 0.025),而且还提高了超大结石的清除率(80.0% vs 40.0%, P = 0.016)。两组的术后并发症发生率相似(6.7% vs 6.5%, P = 0.673),并发症包括胰腺炎(3.3% vs 3.6%, P = 0.357)、胆管炎(2.0% vs 2.2%, P = 0.218)、出血(1.9% vs 0.7%, P = 0.074),并发症症状轻微,均无严重后果。

ESWL最常见的副作用是短暂镜下血尿 [46],此外为发热、胆道出血、胆管炎等。胆管炎是ESWL术后较为严重的并发症,术前未行抗生素治疗的患者可能会出现更加严重的先关后果 [45] [48]。

ESWL耐受性良好、成功率高,即使对于老年患者来说也是如此 [46],与胆道镜辅助碎石术相比,EHL和ILL更具侵入性。对于考虑会出现胆管炎的病人,术前应及时应用抗生素。

6. 胆道镜植入术

括约肌切开术后,并非所有结石都可以通过球囊或篮子取出,老年人的完全结石清除率甚至更低 [49]。当常规取石失败,必须尽快采取下一步治疗,尤其是在存在急性感染性疾病(如胆管炎)的情况下,因为大多数CBDS患者的胆汁受到污染。除非及时获得足够的胆汁引流,否则急性化脓性胆管炎是致命的。胆管结石是引起急性化脓性胆管炎的主要原因 [50],高龄、神经系统共病和憩室周围胆管炎被确定为胆管结石患者发生急性化脓性胆管炎的独立危险因素,而立即植入支架可以挽救高危患者的生命 [50]。

现认为留置内置支架可以使结石逐渐变小、促进结石碎裂,使后续手术更容易清除胆管结石,主要原因包括呼吸和其他胆道运动,这引起支架与结石之间的持续摩擦,促进结石碎裂或使结石变小 [51] [52]。但部分患者在留置支架后,未取得预想中结果,这可能与结石成分有关,例如,棕色结石较软,容易溶解或压碎,而黑色结石和胆固醇结石较硬,这部分结石或许在长期放置塑料支架后会出现解体 [51]。支架类型也有清除效果有关,7-FR的效果要优于10-FR;年龄较大的男性,结石直径较大(>25 mm)清除失败概率高 [53]。胆管炎、支架闭塞和移位是与支架置入相关的常见并发症 [52],为避免长期留置支架出现胆管炎等并发症,需定期更换支架,最佳支架管理时间是每3个月更换一次 [54]。

Palma等人 [55] 认为,永久性胆道支架植入术是一种简单、可靠且有效的方式,对于内镜下无法清除的老年胆管结石患者,永久性支架术可作为替代外科手术的一种方式。但考虑到后续相关并发症的风险,在作为确定性治疗时,应仅限于高度选择的病例(即大于75岁、存在合并症、预期寿命短,尤其是肿瘤患者) [52]。

尽管有胆管炎等相关并发症的发生,但对于内镜下难以处理的胆管结石及不适合手术或高手术风险患者,内镜下放置塑料支架仍是一种简单有、效且安全的方法。塑料支架不仅可以起到引流的作用,还可以使胆管结石逐渐变小,为以后清除创造条件与时机,但需定期更换;永久性胆道支架置入术也许是更难接受手术的老年胆管结石患者的最终治疗方法。

7. 总结

对于直径较大的胆总管结石(>15 mm),建议先行小切口EST + EPLBD,如患者出血风险较高,且不存在远端胆管狭窄,可考虑仅行EPLDB,但仅EPLBD的临床疗效仍需大量的高质量临床随机对照试验进一步证实;若未取得满意结果,且患者基本状况良好,建议行碎石术,如ML (机械碎石术)或Cholangioscopy-assisted lithotripsy (胆道镜辅助碎石术)或ESWL (体外冲击波碎石术),胆道镜辅助碎石效果良好,但设备较为昂贵且复杂,对于术者的经验和专业知识要求更高,在行碎石术时,需综合考量各方面因素。对于暂不耐受长时间手术或急需胆管引流的病人,可考虑行塑料胆道支架植入术,永久性支架植入术也许是内镜下无法清除的老年胆管结石患者的最终治疗方式。此外,当患者病情较为危险或考虑到内镜下胆管结石难以清除时,其它引流方式及外科手术方式也应考虑在内,切勿耽误患者病情。

NOTES

*通讯作者。

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