JCPM Journal of Clinical Personalized Medicine 2334-3354 Scientific Research Publishing 10.12677/JCPM.2024.31016 JCPM-83108 JCPM20240100000_96145824.pdf 医药卫生 ERCP选择性胆管插管困难的研究进展 Advancements in Research on Challenges in Selective Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography (ERCP) 天雨 1 * 海宁 1 2 青海大学附属医院普通外科学二科,青海 西宁 null 04 01 2024 03 01 100 110 © Copyright 2014 by authors and Scientific Research Publishing Inc. 2014 This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/

选择性胆管插管(Selective biliary cannulation, SBS)是内镜下逆行胰胆管造影术(endoscopic retro-grade cholangiopancreatography, ERCP)成功的基础步骤,然而其有着不容小觑的失败率。当标准插管技术失败后,选择何种辅助插管技术及抢救技术以成功实现胆管插管是摆在内镜医师面前的重要难题。本文旨在对困难胆管插管的定义、影响因素、相关并发症及不同辅助插管技术进行综述,以期为内镜医师提供循证医学参考。 Selective biliary cannulation (SBC) constitutes a pivotal step for the success of endoscopic retro-grade cholangiopancreatography (ERCP). However, it poses a significant failure rate that merits at-tention. Identifying the appropriate auxiliary cannulation methods and salvage techniques follow-ing the failure of conventional cannulation approaches is a notable obstacle for endoscopists. This review delves into the complexities surrounding difficult biliary cannulation, including its defini-tion, determinants, associated complications, and adjunctive cannulation strategies, aiming to fur-nish endoscopists with well-founded clinical guidance.

内镜下逆行胰胆管造影术(ERCP),选择性胆管插管,胆管插管困难,应用效果, Endoscopic Retrograde Cholangiopancreatography (ERCP) Selective Biliary Cannulation Cannulation Difficulty Application Effect
摘要

选择性胆管插管(Selective biliary cannulation, SBS)是内镜下逆行胰胆管造影术(endoscopic retrograde cholangiopancreatography, ERCP)成功的基础步骤,然而其有着不容小觑的失败率。当标准插管技术失败后,选择何种辅助插管技术及抢救技术以成功实现胆管插管是摆在内镜医师面前的重要难题。本文旨在对困难胆管插管的定义、影响因素、相关并发症及不同辅助插管技术进行综述,以期为内镜医师提供循证医学参考。

关键词

内镜下逆行胰胆管造影术(ERCP),选择性胆管插管,胆管插管困难,应用效果

Advancements in Research on Challenges in Selective Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography (ERCP)<sup> </sup>

Tianyu Zhang, Haining Fan

Department of General Surgery II, Affiliated Hospital of Qinghai University, Xining Qinghai

Received: Feb. 19th, 2024; accepted: Mar. 15th, 2024; published: Mar. 22nd, 2024

ABSTRACT

Selective biliary cannulation (SBC) constitutes a pivotal step for the success of endoscopic retrograde cholangiopancreatography (ERCP). However, it poses a significant failure rate that merits attention. Identifying the appropriate auxiliary cannulation methods and salvage techniques following the failure of conventional cannulation approaches is a notable obstacle for endoscopists. This review delves into the complexities surrounding difficult biliary cannulation, including its definition, determinants, associated complications, and adjunctive cannulation strategies, aiming to furnish endoscopists with well-founded clinical guidance.

Keywords:Endoscopic Retrograde Cholangiopancreatography (ERCP), Selective Biliary Cannulation, Cannulation Difficulty, Application Effect

Copyright © 2024 by author(s) and beplay安卓登录

This work is licensed under the Creative Commons Attribution International License (CC BY 4.0).

http://creativecommons.org/licenses/by/4.0/

1. 引言

自1968年McCune等 [ 1 ] 首次应用侧视纤维十二指肠镜完成十二指肠乳头插管以来,内镜下逆行胰胆管造影术(endoscopic retrograde cholangiopancreatography, ERCP)已历经逾半世纪的演进。而ERCP技术则于20世纪70年代初被引进我国 [ 2 ] ,随着器材发展及技术进步,其从早期仅作为辅助诊断手段,逐渐演变为胆胰系统疾病的综合诊疗手段。现今,ERCP不仅在提升诊断的精确性方面不断进步,而且在治疗领域中也发挥着重要的作用。其集括约肌切开取石、支架置入引流等多种方法于一体,为胆胰系统疾病提供了更为多样化的诊疗选择。

选择性胆管插管(Selective biliary cannulation, SBS)是ERCP成功的首要一步,然而即便是经验丰富的内镜医师,也存在着不可小觑的插管失败率。据报道,选择性胆管插管的失败率高达18% [ 3 ] ,而某些经验丰富的医师则≤5% [ 4 ] ,另据我国学者报道,胆管插管的失败率约8.1% [ 5 ] 。ERCP胆管插管困难所导致的长时间乳头操作、反复尝试插管及误将造影剂注入胰管,都增加了ERCP相关不良事件的风险,包括ERCP术后胰腺炎(post-ERCP pancreatitis, PEP)、出血、穿孔、胆管炎或其他不良事件。

当十二指肠大乳头可正常窥见时,胆管插管通常以标准插管技术进行,即使用导丝辅助或造影剂引导技术通过套管或括约肌。当标准插管技术因各种因素导致插管失败时,可采用不同辅助插管技术,如预切开技术:经胰管乳头括约肌预切开术(transpan creatic precut sphincterotomy, TPS)、针状刀乳头预切开术(needle knife papillotomy, NKP)、针状刀开窗/造瘘术(needle-knife fistulotomy, NKF),而当导丝误入胰管时,亦可采用双导丝技术(double-guidewire technique,DGW)或胰管支架占据导丝引导插管(wire guide cannulation-pancreatic stent, WGC-PS),这些辅助插管技术一定程度提高了胆管插管困难患者的整体插管成功率。既往当上述技术均失败时,胆道梗阻患者可能需要进行经皮经肝胆道引流术(percutaneous transhepatic cholangial drainage, PTCD),然而PTCD的并发症率很高,并会降低患者的生活质量。当肝内胆管不扩张时亦很难实施。随着超声内镜引导下胆道穿刺引流术(endoscopic ultrasound guided biliary drainage, EUS-BD)的进步,其日益成为ERCP失败后的新选择。此外,另一方面,在考虑较具侵入性替代方案之前,若初次ERCP胆管插管不成功,可以尝试终止手术并择期进行重复ERCP。经皮会合技术(percutaneous-endoscopic rendezvous techniques, PE-RV)在某些情况下也是合适的替代措施。对于消化道重建以致解剖改变的病人,器械辅助式小肠镜辅助ERCP (device-assisted enteroscopy-assisted ERCP, DAE-ERCP)可能更为适宜。

本文将介绍胆管插管困难的不同定义、插管失败原因及相关并发症,并介绍经内镜逆行胰胆管造影术(ERCP)初次插管困难时不同辅助插管技术的应用效果及使用场景,以期为内镜医师在遇到困难胆管插管时提供应对策略及循证医学参考。

2. 胆管插管困难定义

目前不同研究中对胆管插管困难的定义尚无统一标准,尚缺乏共识。Friedland等 [ 6 ] 将插管尝试描述为任何重新定位或重新放置插管装置的行为。虽然多数研究根据胆管插管的尝试次数或时间作为定义依据,然而尝试次数或时间的标准描述目前尚不一致。此外,还须考虑无意中将导丝或造影剂注射到胰管,有研究建议将>4次胰管插管作为插管困难的限制 [ 7 ] ,同时有证据显示胰管插管和胰管造影增加了插管难度及PEP风险 [ 7 ] 。欧洲胃肠内镜学会(European Society of Gastrointestinal Endoscopy, ESGE) 2016年指南 [ 8 ] 建议胆管插管困难定义为下列一种或多种情况:(1) 与十二指肠大乳头接触超过5次;(2) 显影后尝试插管超过5 min;(3) 超过1次意外的胰管插管或显影。2017年的国际共识 [ 9 ] 将插管困难定义为使用标准ERCP技术在10分钟内未能成功或超过5次尝试未完成选择性胆管插管,或无法接近十二指肠大乳头。2018年中国ERCP诊治指南 [ 2 ] 则认为如果反复插管或插管时间超过5~10 min即可认定为胆管插管困难。

3. 胆管插管困难的相关原因

能否顺利实现胆管插管是ERCP成功的关键。而操作者经验和患者自身相关情况是其主要影响因素 [ 8 ] ,有研究 [ 10 ] 显示ERCP经验丰富的医师可提供更高的插管成功率及更少的总体并发症发生率。ESGE建议当受训者完成手术量 > 300例,选择性胆管插管率为≥80% (经过一段时间受指导的独立操作后为90%),结石完全清除率 ≥ 85%,远端胆道狭窄成功支架植入率 ≥ 90% (受指导的独立操作一段时间后分别为90%和95%)时方可认为有能力独立操作ERCP [ 11 ] 。同时ESGE建议可能需要至少12个月的大量培训方能操作ERCP,而至少再需要一年的专门培训才能达到高级ERCP的能力,途中如果培训中断则可能需要更长的时间 [ 11 ] 。对于培训合格的内镜医师则可通过临床操作技能评估(DOPS)或EUS和ERCP技能评估工具(TEESAT)进行评价后操作ERCP [ 12 ] 。而日本的一项研究 [ 13 ] 则发现由非内镜专家操作的ERCP及手术例数较少中心进行的ERCP亦是插管困难的危险因素。ERCP是最具挑战性的内镜手术之一,具有高度复杂性,这可能也是影响选择性胆管插管成功率的重要因素。ERCP的复杂性可以根据Cotton分类 [ 14 ] 、H.O.U.S.E.分类 [ 15 ] 及ASGE分级系统 [ 16 ] 等进行分级,进而量化手术的难度,有利于客观评估插管成功率及并发症发生率。

一项回顾性研究 [ 5 ] 显示胆道良性狭窄、胆道恶性肿瘤、壶腹相关癌等良恶性病变及十二指肠乳头异常、胆胰管汇合异常等疾病因素都会增加插管难度。消化道重建则改变了解剖关系。增加了操作复杂性及潜在风险。而术前完善MRCP等影像学检查可根据相关解剖指标来预测ERCP胆管插管难易程度,进而提高插管成功率。

4. 困难胆管插管的不良影响

胆管插管困难时,长时间的乳头操作致使乳头水肿、反复尝试插管及误将造影剂注入胰管等不当行为,都将增加诸如PEP、出血、穿孔、急性胆管炎或其他并发症的风险。ESGE则将插管困难是PEP的独立危险因素写入指南 [ 8 ] 。ESGE建议将ERCP后胰腺炎定义为:新的或加重的腹痛,合并ERCP后超过24小时的淀粉酶或脂肪酶正常值的3倍以上,并要求住院或延长住院时间 [ 17 ] 。

ERCP后总体不良事件的发生率为5%~10% [ 18 ] 。PEP是ERCP最常见且最严重的并发症,其发生率为3.5%~9.7%,死亡率为0.1%~0.7% [ 17 ] 。ERCP后出血的发生率为0.3%~2% [ 19 ] 。ERCP相关穿孔是ERCP后的严重并发症,发病率为0.1%~1.5% [ 20 ] 。一项最新的Meta分析 [ 21 ] 研究发现PEP总发生率为10.2%,重度PEP发生率为0.5%,死亡率为0.2%。在临床实践中保持高度警惕,预防PEP发生至关重要。同时要识别风险因素,以便对可能发生的并发症进行早期干预,确保患者获得最佳诊疗效果。

5. 胆管插管困难常用辅助插管技术 5.1. 双导丝技术(Double-Guidewire Technique, DGW)

导丝误入胰管是胆管插管的常见问题,而当导丝误入胰管时,常规操作是进行导丝的调整,然而此法是将误入胰管的导丝保留在在胰管内,既发挥标示踪迹也发挥占据空间作用,防止导丝重复误入。再使用第2根导丝在内镜引导下沿11点钟方向进行插管,进入导丝后,如果X线透视下呈“Y”字形,则说明胆管插管成功。此法中1根导丝可保持在胆管内,为内镜和其他操作提供稳定的通道;同时作为示踪标记导引第2根导丝通过起到更好的导引作用。且避免反复操作所带来的相关并发症风险。而胰管导丝则可进行支架置入等操作 [ 22 ] 。双导丝技术也存在一些问题,如操作中可能导致原先置于胰管的导丝不慎脱落;尝试插入第2根导丝时可能会意外重复进入胰管。此外在遇到胰腺解剖异常(胰腺分裂、主胰管曲折)、胰腺恶性肿瘤、胰管插管失败等复杂情况时,双导丝技术的适用性亦受限,需要内镜医师审慎处理 [ 23 ] 。

有关DGT技术的疗效和安全性的数据常存在相互矛盾。Laquière等人最近的一项随机对照试验(RCT)发现早期使用DGT技术可在10分钟内提高胆道插管率 [ 24 ] 。然而一项Meta分析显示,在插管困难的患者中,与其他技术相比,单独使用DGT似乎会增加PEP的风险,且在插管成功率方面没有任何优势 [ 25 ] 。Guzman-Calderon等人对四项RCT进行的另一项Meta分析 [ 26 ] 比较了DGT和TPS,结果显示,DGT在胆道插管方面的成功率较低,PEP的发生率高于TPS。在该Meta分析的四项RCT之一中,PGW组的PEP发生率为2.83%。

ESGE指南建议在胆管插管困难和反复无意进入胰管的情况下推荐使用DGT技术 [ 8 ] 。然而胰管导丝对胰管的损伤及反复胰管开口操作增加了PEP发生的风险。ESGE关于ERCP相关不良事件的指南建议在使用DGT时,使用胰管支架(pancreatic duct stenting, PDS)来预防PEP [ 17 ] 。Wang等人 [ 27 ] 的研究发现,与单独使用吲哚美辛相比,联合使用吲哚美辛和胰管支架有助于接受DGT的患者预防PEP。但目前报道的DGT后发生PEP以轻度PEP为主,中重度PEP极少,且这些病例经保守治疗后均能好转出院 [ 25 ] 。但在该术后是否常规放置胰管支架以预防PEP仍需更多的随机、多中心研究证实。

ESGE关于ERCP相关不良事件的指南 [ 17 ] 建议对没有非类固醇抗炎药(NSAID)禁忌的患者给予100 mg的吲哚美辛或双氯芬酸钠的预先干预,可降低PEP风险。如果存在非甾体抗炎药的禁忌,且无大量补水的禁忌,在ERCP前应使用乳酸林格氏液(3 ml/kg/h)积极补水。对于未放置胰管支架的患者,建议在介入后继续水化,剂量为20 ml/kg,然后以3 ml/kg/h的速度持续8小时,而放置胰管支架者则应在介入后停止大容量治疗。由于缺乏可靠的数据,ESGE不建议将NSAID与其他PEP预防方法常规结合。

5.2. 胰管支架占据导丝引导插管(Wire Guide Cannulation-Pancreatic Stent, WGC-PS)

当导丝误入胰管时,将误入胰管的导丝位置保持不变,并随导丝置入胰管支架,而后再次进行胆管插管。此技术中胰管支架的放置有利于稳定胆管开口,为导丝进行胆管插管提供示踪作用,同时还可降低对胰管开口的损伤与刺激,降低ERCP术后胰腺炎的发生风险。近期有研究报道 [ 28 ] ,尽管WGC-PS技术在提高胆管插管成功率方面与DGW相当,但其优点明显,即能够有效降低PEP发生率及严重程度。目前诸多指南或共识均建议预防性放置胰管支架,通过预防性放置胰管支架,能够有效降低PEP的发生风险。ESGE指南 [ 8 ] 建议在导丝辅助插管及预切技术之前进行预防性胰管支架置入。ESGE指南 [ 8 ] 同时建议在预切操作中,如进入胰管则推荐胰管支架上预切开(PPDS)。一项国内研究 [ 29 ] 显示在插管困难且导丝误入胰管的病例中,使用PPDS方案与DGW/TPS方案相比较,并未显著增加插管成功率(94.6% vs 83.3%, P = 0.18),然而使用PPDS方案组显著降低了术后总并发症发生率(0 vs 20.8%, P = 0.003),同时PEP发生率减低更为明显(0% vs 18.8%, P = 0.005)。

但操作中置入的胰管支架可能会出现移位,且支架的长期留置可能会诱发支架堵塞、感染及周围胰腺损伤。尤其值得注意的是会增加PEP的发生风险。而目前关于ERCP术后胰管支架移除的最佳时机,目前尚无统一共识,且相关研究也并不丰富。2018年发布的中国ERCP指南 [ 2 ] 指出,更推荐优先采用5Fr胰管支架。这是基于其具有高效的置入成功率及较高的自然脱落率,同时伴随的并发症也相对较少。然而支架一旦发生移位,则需予以移除。此外,如果在ERCP术后的5~10天内支架仍未自行脱落,则会增加胰腺炎的发生风险,因此推荐在这种情况下进行内镜手术及时移除支架。值得注意的是,在儿科人群中,胰管支架置入术并未显示出降低PEP的作用。一项关于儿童ERCP的回顾性分析 [ 30 ] 发现,预防性胰管支架置入实际上与PEP的发生率显著相关(P < 0.01),其原因尚不清楚,可能与生理差异和儿童人群胰管直径较小有关。

5.3. 针刀乳头预切开术(Needle Knife Papillotomy, NKP)

即以乳头开口11~12点钟方向作为切入口,用针刀沿胆管十二指肠内段中线,从表层到深层逐层切开,旨在逐渐显露胆管下端括约肌及胆总管本身,当胆总管暴露后使用导丝或导管进行胆管插管,当观察到乳头口有胆汁流出时则预示着插管的成功。NKP技术切口较小,止血迅速方便;可以快速解除结石嵌顿等症状。但同时易发生胰管开口热损伤,增加PEP的发生率;出血较大时会迅速掩盖胆总管开口而致使观察不清。

一项纳入了7984例ERCP的研究 [ 31 ] 报道,在比较NKP组和其他组别,包括TPS组、DGW组以及使用标准插管技术的对照组时,NKP组患者的出血发生比例要显著高于其他各组。但是将混合电流用于在切开术中代替单纯切断电流,可使发生轻度出血的风险降低 [ 8 ] 。

NKP作为辅助插管技术可以明显提高插管成功率,但普遍观点曾认为NKP会增加ERCP术后并发症发生率,尤其是ERCP术后胰腺炎的风险 [ 7 ] 。一项最新研究 [ 32 ] 发现诸如ERCP术后胰腺炎(PEP)等相关并发症的发生并非技术所致,而与重复插管导致的乳头创伤增加等密切相关。早期预切由于有助于减少对乳头黏膜的反复刺激,不会致使乳头水肿,可降低PEP发生风险并提高插管成功率。2014年ESGE预防PEP指南 [ 7 ] 中提到,在胆管插管困难病例中,早期预切开较持续尝试标准插管相比,PEP发生率较低,但两种方式的总体成功率和并发症发生率相似。Sundaralingam等 [ 33 ] 的一项Meta分析发现,困难胆管插管情况下,早期预切在降低PEP发生率及提插管成功率方面优于持续使用标准技术进行插管。Chen等人 [ 34 ] 进行的一个包含6项研究的Meta分析也发现与持续标准插管相比,早期预切开可降低PEP发生率。目前关于预切“早期”的时间尚没有统一的共识,不同研究的时间差异也较大。但在发生胆管插管困难时,内镜医师尽早预切不仅可显著提高插管成功率,并可减少相关并发症的发生率 [ 35 ] 。

5.4. 针刀开窗/造瘘术(Needle-Knife Fistulotomy, NKF)

即用针刀在距离十二指肠乳头开口约5mm的黏膜处进行穿刺,制造一个人工瘘口,使之提供一个操作通道。而后沿11点方向用针刀作延续性切开,直至显露远端胆管,而后进行胆管插管。其与传统NKP具有明显优势,传统NKP往往造成括约肌及乳头口周围组织的损伤,而针刀造瘘术则继续保留了括约肌和乳头口的完整结构,且其显著降低了因热效应和机械操作带来的损伤风险,进而进一步提高了辅助插管的成功率,降低了术后胰腺炎的发病率 [ 36 ] 。但NKF对内镜医师解剖知识和操作熟练度及稳定性要求较高。

2019年和2020年发表的2项研究 [ 37 ] [ 38 ] 均支持了NKF的PEP风险总体较低的观点。2016年ESGE指南 [ 8 ] 建议NKF作为胆管困难插管时首先考虑的预切技术。2016年Lopes等 [ 39 ] 进行的一项回顾性研究发现熟练的内镜医师可以很容易地掌握NKF且不良事件很少,研究认为所有内镜医师都应该进行NKF培训,应至少行20次NKF来证明受训人员的能力。

5.5. 经胰管乳头括约肌预切开术(Transpan creatic Precut Sphincterotomy, TPS)

即使用弓刀从乳头开口11~12点钟方向开始向上逐层切开,当遇到胆管与胰管共同开口处间隔时亦进行切开,进而显露胆管下端进行插管。该术式切口小,切口的方向和深度易控制,有利于避免反复胰管插管导致的乳头水肿,同时方便放置胰管支架进行胰液引流。但是如果切割力度把握不好则易致穿孔。

2017年的一项Meta分析 [ 40 ] 显示,与NKP相比,TPS具有比NKP更高的胆管插管成功率,且出血更少,然而在PEP、穿孔及总并发症方面没有显著差异。一项前瞻性随机研究 [ 41 ] 显示,TPS的胆道插管成功率明显高于DGT (94.1%比58.8%),两组PEP发生率均为2.9%,两组插管相关并发症发生率差异无统计学意义。

一项Meta分析 [ 42 ] 发现,TPS在提高插管成功率方面明显优于早期预切,且DGW和持续标准插管的术后胰腺炎发生风险明显高于上述两种技术。以上证据表明TPS的安全性和有效性优于NKP。ESGE建议 [ 8 ] ,对于难以插管的小乳头患者,如果在无意中将导丝插入胰管内,应考虑TPS。同时对于接受TPS的患者,ESGE建议预防性放置胰管支架。相比其他技术,TPS的切口方向和切开深度更容易得到控制,其并发症发生风险较低,技术门槛较低,有利于低容量中心及内镜初学者在专家指导下较快掌握,进而有效提高了插管困难时的成功率。

6. 辅助插管技术失败后的补救技术 6.1. 重复ERCP (Repect-ERCP)

部分插管困难者在各种插管技术辅助下仍不能实现成功的胆管插管。而频繁操作或者长时间尝试插管,可能导致十二指肠乳头充血和水肿。这会进一步增加胆管插管的难度及并发症的发生风险。在这种情况下,建议立即终止ERCP手术操作,当间隔数天后,乳头水肿发生自行消退,组织坏死及出血随时间推移得到改善,而后再考虑尝试进行第2次ERCP。

有研究 [ 43 ] 比较了当初次ERCP困难插管发生,使用NKP辅助胆管插管失败后,患者接受间隔数天后进行重复ERCP其他有创操作(如PTCD、外科胆道手术引流)的疗效。间隔数天后进行重复ERCP比初次插管失败后立即进行有创操作显示处更高的插管成功率和更低的并发症发生率。可能由于反复NKP或反复插管导致的乳头充血水肿、组织坏死及出血随着时间的推移得到改善。

重复ERCP的成功率似乎与间隔时间有关 [ 44 ] [ 45 ] ,间隔时间充分时成功率更高。但目前关于第2次ERCP的实施时间尚存争议。Kim等人 [ 45 ] 研究发现间隔1天的插管成功率明显低于2~3天的成功率(65.7% vs 88.2%),且除时间间隔外未发现其他因素与重复ERCP成功显著相关。Colan-Hernandez等人 [ 44 ] 研究发现第2次ERCP应至少间隔4天进行才是安全有效的。但临床经验提示间隔时间也应有一定时间限制而不能间隔太久。

6.2. 经皮经肝胆道引流术(Percutaneous Transhepatic Cholangial Drainage, PTCD)

即应用穿刺针在超声或其他影像学措施引导下采用经皮穿刺方法,通过肝组织精准进入胆管,穿刺完成后置入导丝,通过预留导丝进行胆管插管。这是一种成熟的胆汁引流方法。特别适用于无法通过内镜正常到达十二指肠大乳头的情况下,如胃流出道梗阻、十二指肠支架置入状态及消化道重建术后解剖结构改变时 [ 2 ] 。

有研究报道其成功率与EUS-BD相当,但国外的两项Meta分析 [ 46 ] [ 47 ] 研究报道PTCD相比EUS-BD其总体不良事件发生率(感染、胆管炎等)及中重度不良事件的发生率更高。而外引流会引起不适和疼痛,经常需要再次干预,且长期成本高昂。此外在肝内胆管未充分扩张时,PTCD进行的难度更大,这限制了PTCD在部分困难胆管病例中的应用。

有研究报道 [ 48 ] 一种结合了经皮和内镜方法的改进技术,称为经皮–经肝–内镜会合手术(PTE-RV),似乎比PTCD更可取。使用小口径导管进行经肝穿刺术,从而减少并发症;允许内镜医师通过汇合通道进行治疗性ERCP;同时虽然PTBD是PTE-RV的一部分,但一旦胆道梗阻得到解决,经皮途径就可以关闭 [ 49 ] 。

6.3. 超声内镜引导下胆道穿刺引流术(Endoscopic Ultrasound Guided Biliary Drainage, EUS-BD)

目前EUS-BD日益成为初次ERCP插管失败后的辅助插管技术手段 [ 50 ] ,其可采用多种途径,主要包括经胃肝内途径及经十二指肠肝外途径两种方式。在EUS引导下成功穿刺肝内胆管或胆总管后,可通过顺行或者会合技术或顺行完成后续治疗,实现胆道引流 [ 51 ] 。有研究报道EUS-BD显示出较高的成功率,其可高达90%,然而相关并发症发生率约为20% [ 2 ] ,值得注意的是,选择不同的穿刺路径对于患者的安全性有显著影响。有研究 [ 52 ] 发现,经胃肝内入路不良事件发生率约为21.7%,而经十二指肠肝外入路不良事件发生率约为9.9%。选择最佳的引流途径对于降低术后并发症、保证患者安全性具有重要的临床意义。而近年提出的EUS混合交汇技术(EUS-hybrid rendezvous technique, EUS-HRV)被认为是适用于经肝内胆管入路插管失败时的补救技术 [ 53 ] 。

EUS-BD和PTCD在技术成功率方面相当,但是EUS-BD在其他方面具有诸多优势,如具有更高的临床成功率及较低的并发症发生风险,而这则进一步降低了再次干预的概率,同时降低了患者的经济负担。2022年ESGE关于内镜超声指南 [ 54 ] 建议恶性胆道远端梗阻初次ERCP失败使用EUS-BD而不是PTCD。同时有研究 [ 55 ] 发现EUS-BD初学者成功率较低,且并发症较多,需要一定的学习曲线才能达到临床效果,但是随着技术的不断进步,相关从业人员的技术门槛会越来越低,EUS-BD越来越成为困难胆管插管的一线治疗措施。

6.4. 经皮会合技术(Percutaneous-Endoscopic Rendezvous Techniques, PE-RV)

主要包括经皮经肝胆道引流(PTBD)和内镜下引流技术的结合应用,即在超声或CT引导下用穿刺针经皮穿刺进入胆管,进而留置导丝,随后在内镜下于十二指肠乳头处定位该导丝并用其进行胆管插管。其作为胆管插管初次失败后的重要抢救技术,特别适用于壶腹部肿瘤及消化道术后等涉及解剖结构改变的患者 [ 56 ] 。但此技术需要大容量中心经长期训练的内镜医师方可完成,对技术要求较高,培训周期较长;同时该操作涉及经皮穿刺进入胆管,胆道损伤的风险较高。

6.5. 器械辅助式小肠镜辅助ERCP (Device-Assisted Enteroscopy-Assisted ERCP, DAE-ERCP)

Katanuma等 [ 57 ] 统计了日本2012年11个中心的ERCP开展情况,其中约有6.5%的病例是接受消化道重建术后接受ERCP的。传统的ERCP为屈曲型内镜,更适用于正常的消化道解剖结构。然而消化道重建术改变了原有的正常解剖结构。如重建形成较长的输入段肠袢,使得传统内镜难以到达十二指肠大乳头及胆管;同时重建使得十二指肠乳头解剖位置改变,致使常规的内镜插管方向需要做出极大调整,有时甚至与标准ERCP所采用的方向完全相反,这些因素大大增加了胆管插管的难度,且增加了操作风险。

器械辅助式小肠镜(device-assisted enteroscopy, DAE)通过内镜尾端所配置的气囊,可以在内镜向前推进时将肠道固定,减少肠道滑移,并使内镜深入推进到解剖位置改变后的胆胰管开口。随着DAE技术的迅速发展,已有双气囊小肠镜(double-balloon enteroscopy, DBE)、单气囊小肠镜(single-balloon enteroscopy, SBE)、螺旋式小肠镜(spiral enteroscopy, SE)及水力扩张小肠镜(Hydrostatic-balloon Enteroscopy)等诸多新型内镜投入使用。

一项纳入14例胆管空肠Roux-en-Y吻合术后接受DBE-ERCP的研究 [ 58 ] 显示,在能够通过内镜到达Roux-en-Y吻合部位的13例患者中,100%实现了成功插管,其中92.3% (12/13)的患者在DBE-ERCP后实现了有效治疗。仅有1例患者因胆总管多发性结石而需要接受外科手术。Inamdar等 [ 59 ] 的一项Meta分析显示,通过消化道重建术后采取SBE-ERCP技术,内镜成功到达胆胰管开口的概率为80.9%,插管成功率为69.4%,而整体成功治疗率为61.7%。在这些病例中,约6.5%出现了ERCP相关并发症。虽然DAE应用越来越普遍,但其应用尚存诸多限制。首先,DAE作为前视镜,其视野角度和视野范围可能导致在确定特定解剖结构,如确定十二指肠或重建术后的吻合口位置时难以辨别。其次,DAE由于抬钳器的缺失,限制了其进行插管时对内镜前进方向的精细控制,不仅使ERCP操作变得困难,而且可能会增加手术失败率并延长操作时间。而且DAE与传统ERCP使用的内镜配件存在兼容性问题。大多数为标准ERCP设计的器可能不适用于DAE,导致其应用受限。

7. 小结和展望

本文回顾了困难胆管插管的不同定义、影响因素、相关并发症及不同辅助插管技术,虽然目前辅助插管技术及抢救性辅助插管技术越来越丰富,但在不同情况下如何选择更有效的辅助插管技术仍然是摆在内镜医师面前的一道难题。希望未来更多的前瞻性研究可以更加关注困难胆管插管这一难题,为内镜医师在困难胆管插管时应对策略的制定提供循证医学参考。

文章引用

张天雨,樊海宁. ERCP选择性胆管插管困难的研究进展Advancements in Research on Challenges in Selective Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography (ERCP)[J]. 临床个性化医学, 2024, 03(01): 100-110. https://doi.org/10.12677/JCPM.2024.31016

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