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摘要:
急性胆囊炎的基础治疗方法为外科手术切除胆囊,尤其是腹腔镜胆囊切除术。但部分高危手术患者需要行胆囊引流术,传统引流方法为经皮经肝胆囊穿刺引流术。但近年来内镜下经十二指肠乳头胆囊引流术和内镜超声引导下胆囊引流术两种内镜引流方法飞速发展,且长期效果良好。笔者通过文献回顾,深入探讨2种内镜引流方法的历史发展、技术特点、技术比较、不良事件和长期效果等。
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关键词:
- 胆道疾病 /
- 急性胆囊炎 /
- 内镜下经十二指肠乳头胆囊引流术 /
- 内镜超声引导下胆囊引流术 /
- 现状 /
- 进展
Abstract:The fundamental treatment for acute cholecystitis is surgical cholecystectomy, especially laparoscopic cholecystectomy. Some high-risk surgical patients need gallbladder drainage. The traditional drainage method is percutaneous transhepatic gallbladder drainage. However, in recent years, two endoscopic approaches, including endoscopic transpapillary gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage, have developed rapidly and have advantages in long-term outcomes. In this article, the authors discuss the historical development, technical characteristics, comparison between methods , adverse events and long-term outcomes of the two endoscopic drainage methods through literature review.
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急性胆囊炎是常见疾病,也是外科急腹症常见病因,仅次于急性阑尾炎,LC是其标准治疗方法[1]。但部分手术高危患者需行胆囊引流术,传统引流方法为经皮经肝胆囊穿刺引流术（percutaneous transhepatic gallbladder drainage,PTGBD）。PTGBD最早报道于20世纪70年代,被证明非常有效,技术和临床成功率分别为98%和90%,不良事件发生率较低（3.7%）[2]。有大量证据支持其在胆囊炎非手术治疗中的应用[3‑5]。但PTGBD仅为临时措施,长时间放置引流管有胆囊炎复发、引流管移位等风险,且PTGBD会带来不便和不适,降低患者生命质量[6‑7]。此外,凝血功能障碍或明显腹水等情况是PTGBD禁忌证。近年来内镜下经十二指肠乳头胆囊引流术（endoscopic transpapillary gallbladder drainage,ETGBD）和内镜超声引导下胆囊引流术（EUS‑guided gallbladder drainage,EUSGBD）2种内镜引流方法飞速发展,可实现胆囊内引流,并且具有长期效果的优势。笔者通过文献回顾,深入探讨2种内镜引流方法的历史发展、技术特点、技术比较、不良事件和长期效果等。
一、历史发展
（一）ETGBD的历史发展
1984年Kozarek[8]首次报道行ERCP时主动向胆囊管插管（成功率为74%）,认为这有助于胆囊可视化,抽取胆汁进行分析、培养和药物敏感性实验,以及有潜在溶石或取石可能。1991年Tamada等[9]描述14例急性胆囊炎患者行胆囊支架置入术,其中64%的患者症状缓解,57%的患者影像学缓解。后续研究也证实该引流方式的有效性[10‑12]。
（二）EUSGBD的历史发展
Kwan等[13]2007年首次报道EUS引导下胆囊穿刺,抽取胆汁并留置双猪尾塑料支架。后续报道中主要使用塑料支架或自膨式金属支架,但这2种支架发生移位和胆漏的风险较高。双侧管腔贴合金属支架（lumen‑apposing metal stent,LAMS）基本解决上述问题[14]。LAMS又称为哑铃型或双蘑菇头金属支架,两端的蘑菇头可使胃壁和（或）肠壁与胆囊壁贴合、固定在一起,可减少发生支架移位和胆漏风险,且LAMS为全覆膜支架,中央管腔直径通常为10~20 mm,后期还可以使用细镜进入胆囊腔内实施治疗[15‑17]。
2014年Teoh等[18]首次报道使用新型、前端带电烧灼功能LAMS （cautery‑enhanced lumen‑apposing metal stent,CE‑LAMS）行EUSGBD,这种新型支架无需交换导丝即可一次完成穿刺、扩张和释放支架,减少交换次数和操作时间,且无需X线辅助,优势明显,国内目前刚应用于临床。
二、技术特点
（一）ETGBD的技术特点
ETGBD又分为内镜下鼻胆囊引流术和内镜下胆囊支架引流术,两者操作过程类似,均需先行ERCP将导丝通过胆囊管并使其盘绕在胆囊腔内,然后将鼻胆管或支架一端送入胆囊。可不切开括约肌,但如需同时治疗胆总管结石或使用胆道镜辅助胆囊管插管时,可先切开括约肌。2种技术的临床成功率相似,但鼻胆管会增加患者不适,且不宜长期携带,通常仅作短期过渡措施[19‑21]。胆囊支架通常选用直径为5~10 Fr,长度≥12 cm的双猪尾塑料支架。
ETGBD难点在胆囊管插管,常见困难如不易确定胆囊管开口；胆囊管长、窄、弯；胆囊管因炎症、结石或肿瘤而梗阻等[22]。此外,如果患者已经置入胆道自膨式金属支架,会极大增加进入胆囊管的难度。
Ogawa等[23]对11例患者的超声特征进行回顾性评估结果显示：技术成功与胆囊短轴长度较短（27.4 mm比38.0 mm,P =0.008）和胆囊壁较薄（4.2 mm比9.0 mm,P =0.041）相关。胆囊短轴越长或胆囊壁越厚可能意味着胆囊炎症越重,从而更易导致胆囊管狭窄。关于提高胆囊管插管成功率的方法包括使用不同导丝（更细导丝、有角度的导丝、旋转导丝等）,导管辅助（如微导管和弯曲导管）,球囊反弹法,以及胆道镜辅助插管[2,24‑31]。Shin等[28]描述了使用胆道镜放置鼻胆囊引流管的成功率为87.5%（7/8）。Ridtitid等[31]对透视辅助胆囊管插管失败的患者（41例）使用胆道镜直视辅助插管,结果显示：23例（56%）成功完成胆囊支架置入,ETGBD技术成功率提高了22%。
Sagami等[32]提出使用导管内超声引导胆囊管插管,其将100例连续胆囊炎患者分为无导管内超声辅助组（前50例）和导管内超声辅助组（后50例）,结果显示：导管内超声辅助组技术成功率显著提高（92.0%比76.0%,P =0.044）,而手术时间没有显著延长（74.0 min比66.7 min,P =0.310）。此外,还有通过PTCD导管顺行将导丝通过胆囊管从而“会师”完成ETGBD的报道[33‑34]。
有时导丝已经进入胆囊腔,但由于结石嵌顿等原因导致支架仍无法通过胆囊管。有学者建议在置入支架前,将导管和（或）括约肌切开刀或扩张球囊等先通过胆囊管,以拉直和扩张胆囊管[20,22,35]。Ban等[36]报道使用Soehendra支架回收器沿导丝旋转通过胆囊管后顺利将支架置入胆囊的案例。
Mohan等[37]一项荟萃分析包括22项研究（1 223例ETGBD患者）,结果显示：技术成功率为83.0%（95%CI为80.1%~85.5%,I 2=29%）。最近的一项关于ETGBD的荟萃分析纳入21项研究（1 307例ETGBD患者）,技术成功率为82.62%（95%CI为80.63%~84.52%）[38]。
（二）EUSGBD的技术特点
EUSGBD按途径主要分为经胃或经十二指肠,消化道改道患者也可经空肠进行穿刺,通常是选择胃壁和（或）肠壁与胆囊壁贴近且避开主要血管位置进行穿刺。与胃比较,十二指肠位于腹膜后而且更靠近胆囊,可能更有利于通道稳定；而胃壁较厚且蠕动明显,胃腔与胆囊腔距离相对较远,这都不利于通道稳定[14,39‑40]。但如果后期计划行胆囊切除术,则可考虑经胃途径,因为胃的瘘口更容易在术中修补。EUSGBD主要挑战之一是胆囊容易塌陷。Zhang等[41]描述了一种可回收的穿刺锚牵引装置固定胆囊壁。
LAMS放置失败,主要原因包括导丝未能穿过增厚的胆囊壁,远端蘑菇头移位,支架过早释放,穿孔,大出血以及无法找到安全的胆囊穿刺部位[15]。CE‑LAMS能使操作过程更简单,可能提高成功率,但目前尚缺少足够证据。Kalva等[42]纳入13项（233例患者）关于LAMS应用于EUSGBD研究的荟萃分析结果显示：技术成功率为93.86%（95%CI为90.56%~96.49%）。另一纳入8项（393例患者）关于LAMS研究的荟萃分析结果显示：EUSGBD合并技术成功率为94.9%[43]。Dollhopf等[44]回顾性分析75例使用CE‑LAMS引流的急性胆囊炎患者,其技术成功率为98.7%,其中57%的患者使用CE‑LAMS直接穿刺进入胆囊腔,43%的患者沿导丝进入。EUSGBD的技术成功率高于ETGBD。
（三）ETGBD和EUSGBD的适应证与禁忌证
对于手术风险高、无游离性胆囊穿孔证据且可耐受麻醉和（或）镇静的患者,均可考虑行内镜引流。如果患者伴凝血功能障碍或大量腹水等情况,则不利于穿刺引流,更适合选择ETGBD；如果患者由于胆总管结石等原因需要行ERCP,则可首选ETGBD。此外,由于ETGBD可以保留胆囊壁结构完整,如果患者计划过渡至胆囊切除术,则通常首选ETGBD[45]。如果可疑或明确的胆囊管梗阻或通过困难,已留置胆道金属支架等则更适合选择EUSGBD。EUSGBD若造成慢性胆肠瘘或胆胃瘘,需要在后续胆囊切除术中修复,这增加了手术复杂性。但一项关于EUSGBD后行胆囊切除术的回顾性研究结果显示：EUSGBD与PTGBD后行胆囊切除术患者中转开腹率、术后不良事件发生率比较,差异均无统计学意义[46]。
三、技术比较
（一）ETGBD与PTGBD比较
一项大样本量（ETGBD 1 223例,PTGBD 13 351例）荟萃分析结果显示：ETGBD与PTGBD比较,技术成功率较低（83%比98.7%,P =0.001）,而临床成功率、总体不良事件比较,差异均无统计学意义[37]。一项回顾性倾向评分匹配研究结果显示：ETGBD与PTGBD比较,技术成功率较低（77%比100%,P =0.004）,术后并发症发生率比较,差异无统计学意义（12.1%比4.8%,P =0.20）,但行PTGBD的患者住院时间更长[47]。另一项多中心回顾性倾向评分匹配研究结果显示：ETGBD与PTGBD比较,3 d内临床成功率更高（69.8%比59.6%,P =0.023）,但7 d内临床成功率无显著区别（89.2%比85.7%,P =0.25）,术后并发症发生率也无显著区别（8.2%比5.6%,P =0.228）[48]。
Inoue等[33]的一项长期（中位随访时间为485 d）随访结果显示：PTGBD比ETGBD患者的胆囊炎复发率更高（17.2%比0,P =0.04）。Kaura等[49]的回顾性研究结果显示：PTGBD组（52例）患者比ETGBD组（140例）患者胆囊切除术前意外再干预率更高（16.4%比7.7%,P =0.02）,但后续胆囊切除术相关术后合并症发生率及中转开腹率比较,差异均无统计学意义。
综上,虽然ETGBD临床成功率低于PTGBD,但两者临床成功率和对后续胆囊切除术的影响类似,PTGBD复发率和再干预率更高。
（二）ETGBD与EUSGBD比较
多项研究和Meta分析结果均显示：EUSGBD的技术成功率和临床成功率均较ETGBD高[22,37,50‑52]。一项大样本量（ETGBD 1 223例,EUSGBD 557例）荟萃分析结果显示：EUSGBD与ETGBD比较,技术成功率（95.3%比83%,P =0.001）和临床成功率（96.7%比88.1%,P =0.001）均更高,而胆囊炎复发率相似（4.2%比4.6%,P =0.990）[37]。
Krishnamoorthi等[51]的一项荟萃分析结果也显示：EUSGBD与ETGBD比较,技术成功率（合并OR=5.22,P =0.0006,I2=20%）和临床成功率（合并OR=4.16,P =0.0001,I 2=19%）均更高,复发率更低（合并OR=0.33,P =0.01,I 2=0）,但总体不良事件发生率比较,差异无统计学意义。Oh等[52]的回顾性研究结果显示：EUSGBD与ETGBD比较,技术成功率（99.3%比86.6%,P<0.01）和临床成功率（99.3%比86%,P<0.01）均更高,且不良事件发生率（7.1%比19.3%,P =0.02）较低。
（三）EUSGBD与PTGBD比较
一项多中心RCT对无法行外科手术的急性胆囊炎患者（EUSGBD 39例,PTGBD 40例）进行比较,EUSGBD采用CE‑LAMS支架,EUSGBD和PTGBD的患者技术成功率（97.4%比100%,P =0.494）临床成功率（92.3%比92.5%,P =1）和30 d死亡率（7.7%比10%,P =1）比较,差异均无统计学意义。但EUSGBD的患者30 d后再干预率（2.6%比30%,P =0.001）,计划外再入院率（15.4%比50%,P =0.002）,复发性胆囊炎（2.6%比20%,P =0.029）,30 d不良事件发生率（12.8%比47.5%,P =0.010）和1年不良事件发生率（25.6%比77.5%,P<0.001）等方面显著降低[53]。另一项单中心RCT比较EUSGBD（30例）和PTGBD（29例）治疗急性胆囊炎手术高危患者的疗效,结果显示：两者技术成功率（97%比97%）临床成功率（100%比96%）和不良事件发生率（7%比3%,P =0.492）比较,差异均无统计学意义。但EUSGBD组患者术后疼痛评分低于PTGBD组（1分比5分,P <0.001）；值得注意的是,该研究中EUSGBD采用鼻胆管引流[54]。Mohan等[37]的荟萃分析结果则显示：EUSGBD（557例）与PTGBD（13 351例）比较,技术成功率较低（95.3%比98.7%,P =0.001）,但EUSGBD患者的临床成功率高（96.7%比89.3%,P =0.001）,两者总体不良事件发生率比较,差异无统计学意义。
Luk等[55]的荟萃分析结果显示：急性胆囊炎手术高危患者分别行EUSGBD（206例）和PTGBD（289例）,技术成功率（OR=0.43,95%CI为0.12~1.58,P =0.21,I 2=0）和临床成功率（OR=1.07,95%CI为0.36~3.16,P =0.90,I 2=44%）比较,差异无统计学意义。但EUSGBD的患者不良事件发生率（OR=0.43,95%CI为0.18~1.00,P =0.05,I 2=66%）,再干预率（OR=0.16,95%CI为0.04~0.42,P<0.001,I 2=32%）,计划外再入院率（OR=0.16,95%CI为0.05~0.53,P =0.003,I 2=79%）均降低,住院时间缩短（标准平均差为‑2.53,95%CI为-4.28~-0.78,P =0.005,I 2=98%）,复发性胆囊炎或疾病相关死亡率比较,差异无统计学意义。
一项国际多中心回顾性研究比较PTGBD（146例）、EUSGBD（102例）、ETGBD（124例）应用于手术高危胆囊炎患者,结果显示：技术成功率（98%比94%比88%,P
=0.003）和临床成功率（97%比90%比80%,P<0.001）均为PTGBD>EUSGBD>ETGBD,长期不良事件发生率（20%比2%比5%,P =0.01）,需要额外外科干预率（49%比4%比11%,P <0.000 1）和平均住院时间（19 d比16 d比18 d,P =0.01）均为EUSGBD最优[22]。 综上,EUSGBD和PTGBD的技术成功率和临床成功率相似,但EUSGBD再干预率、计划外再住院率、长期不良事件发生率、住院时间等方面更优。
（四）ETGBD、EUSGBD与PTGBD比较
一项纳入10项研究（1 267例患者,302例ETGBD,472例EUSGBD,493例PTGBD）网络荟萃分析比较胆囊引流方法,网络排名评估显示：PTGBD和EUSGBD技术成功的可能性最高（EUSGBD比PTGBD比ETGBD=2.00比1.02比2.98）,临床成功的可能性最高（EUSGBD比PTGBD比ETGBD=1.48比1.55比2.98）。EUSGBD复发胆囊炎的风险最低（EUSGBD比PTGBD比ETGBD=1.089比2.02比2.891）。PTGBD具有最高的再干预风险（EUSGBD比PTGBD比ETGBD=1.81比2.99比1.199）和计划外再入院风险（EUSGBD比PTGBD比ETGBD=1.582比2.944比1.474）,而ETGBD引流与最低死亡率相关（EUSGBD比PTGBD比ETGBD=2.62比2.09比 1.29）[56]。
四、不良事件
（一）ETGBD不良事件
与ETGBD相关的不良事件除了ERCP固有的并发症,包括胰腺炎、出血、穿孔和胆管炎等,还有一些特有的不良事件包括胆囊管或胆囊穿孔、支架移位、胆源性疼痛和胆囊炎复发等。ETGBD的胰腺炎发生率与标准ERCP相当,但多数研究没有报道是否使用预防性胰管支架或直肠消炎痛栓等方法减少ERCP术后胰腺炎,而支架移位或堵塞发生率为2%~12%[21‑22,29,57‑58]。
一项关于ETGBD的荟萃分析结果显示：合并总并发症发生率为8.83%（95%CI为7.42%~10.34%）。术后不良事件发生率为出血1.03%（95%CI为0.58%~1.62%）,穿孔0.78%（95%CI为0.39%~1.29%）,腹膜炎和（或）胆漏0.45%（95%CI为0.17%~0.87%）,胰腺炎1.98%（95%CI为1.33%~2.76%）,支架阻塞为0.39%（95%CI为0.13%~0.78%）,支架移位率为1.3%（95.0%CI为0.75%~1.99%）。ETGBD后胆囊炎合并复发率为1.48%（95%CI为0.92%~2.16%）[38]。
Mohan等[37]和Khan等[21]进行的2项荟萃分析结果显示：合并不良事件发生率分别为9.6%（95% CI为5.9%~15.3%,I2=27%）和10%（95%CI为7%~13%,I2=27%）。
Lee等[58]的一项随访时间为586（11~1 403）d的研究结果显示：20%的患者出现延迟不良事件,包括支架移位、复发性胆源性疼痛和胆管炎。
（二）EUSGBD不良事件
EUSGBD常见的不良事件包括出血、支架移位和复发性胆囊炎。相对少见的不良事件包括支架堵塞、胆汁渗漏和（或）腹膜炎、吸入性肺炎、胰腺感染、胆石性肠梗阻等[59]。
Kalva等[42]进行的一项纳入13项研究（233例）荟萃分析结果显示：使用LAMS的EUSGBD总体不良事件发生率为18.31%（95%CI为13.49%~23.68%）,支架相关不良事件发生率为8.16%（95%CI为4.03%~14.96%）,穿孔发生率为6.71%（95%CI为3.65%~10.60%）,复发性胆管炎和（或）胆囊炎发生率为4.05%（95%CI为1.64%~7.48%）。
Mohan等[43]纳入8项使用LAMS的EUSGBD研究（393例患者）荟萃分析结果显示：合并不良事件发生率为12.7%（95%CI为8.4%~18.7%,I2=7.7）,早期不良事件发生率为6.5%（95%CI为4.2%~10.0%,I2=1.2%）,延迟不良事件发生率为8.3%（95%CI为5.8%~11.9%,I2=4.8%）。按亚型划分的不良事件总发生率为出血（4.2%,95%CI为2.2%~7.9%,I 2=31.8%）,胆漏（2.4%,95%CI为1.1%~5.1%,I2=0）,支架阻塞（5.2%,95%CI为3.0%~8.7%,I2=0）,穿孔（2.3%,95% CI为1.1%~4.7%,I2=0）,支架移位（3.2%,95%CI为1.8%~5.8%,I 2=0）,复发性胆囊炎和（或）胆管炎（4.6%,95%CI为2.6%~8.0%,I2=0）和死亡（5%,95% CI为2.6%~9.5%,I2=36.4%）。死亡为最终患者结果,主要归因于潜在的伴随疾病,而不是与内镜手术直接相关的死亡事件。
Teoh等[53]的多中心前瞻性RCT结果显示：与PTGBD比较,EUSGBD的不良事件发生率显著降低,30 d的不良事件发生率（12.8%比47.5%,P =0.010）,1年不良事件发生率（25.6%比77.5%,P<0.001）均降低。
五、长期效果
（一）ETGBD长期效果
ETGBD长期效果主要关注的是内镜下胆囊支架引流术。一项前瞻性研究结果显示：采用Kaplan⁃Meier法,ETGBD中位通畅时间为760 d[58]。代表在支架阻塞的情况下,仍可获得通畅胆囊引流。Inoue等[33]对33例接受ETGBD的患者进行长期随访,随访时间为473（13~1 095）d,随访期间未发现复发；对照组为29例接受PTGBD的患者,随访时间为485（30~1 873）d,复发率为17.2%。
Maekawa等[60]的研究结果显示：在长期随访期间,ETGBD复发率为3.3%,93.5%的患者在未更换支架的情况下,随访期间（1个月至5年）内无症状。但Mutignani等[61]的研究结果显示：8例接受EGBD支架治疗的患者中,2例在随访期（中位随访时间为17个月）内复发。
（二）EUSGBD长期效果
Choi等[62]对56例EUSGBD患者进行随访,随访时间为275（40~1 185）d,延迟不良事件发生率为7.1%（95%CI为5.7%~8.4%）,包括2例无症状的远端支架移位和2例支架阻塞引起的复发性急性胆囊炎,均经内镜处理。3年累积支架通畅率为86%。该研究中采用带有抗移位设计的部分覆膜自膨式金属支架。Ahmed等[63]对13例连续接受EUSGBD（使用自膨式金属支架）的患者进行随访,随访时间为24（14~945）d,其中1例患者（7.7%）胆囊炎复发。Teoh等[53]的多中心前瞻性RCT对39例EUSGBD患者中的27例（69.23%）进行经口胆囊镜检查（另12例患者拒绝）,结果显示：27例接受胆囊镜检查的患者中,24例已经自发排净胆囊结石。Yuste等[64]的一项回顾性研究评估LAMS放置时间≥1年的EUSGBD患者的长期结果,结果显示：第1年的初始队列中有支架移位、支架功能障碍和致命性出血在内的不良事件,但在中位时间24.4个月的随访时间内,没有出现与LAMS相关的后续不良事件（IQR为18.2~42.4；范围为12.3~62.4）。综上,内镜下胆囊支架引流术和EUSGBD都有较好的长期效果。
六、结语
综上,对于外科手术高风险的胆囊炎患者,2种内镜下引流方式ETGBD和EUSGBD均安全、有效,均具有较高的临床成功率。与传统PTGBD比较,两者都具有较好长期效果。随着相关新型设备和耗材的发展迅速,笔者预测：内镜下引流方式会越来越普及,在胆囊炎引流领域将占据更加重要的地位。
所有作者均声明不存在利益冲突边大鹏, 冯秋实. 内镜引流治疗急性胆囊炎的现状与进展[J]. 中华消化外科杂志, 2022, 21(7): 884-891. DOI: 10.3760/cma.j.cn115610-20220509-00261.http://journal.yiigle.com/LinkIn.do?linkin_type=cma&DOI=10.3760/cma.j.cn115610-20220509-22261
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