Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline

This article is part of a combined publication that expresses the current view of the European Society of Gastrointestinal Endoscopy about endoscopic biliary stenting. The present Clinical Guideline describes short-term and long-term results of biliary stenting depending on indications and stent models; it makes recommendations on when, how, and with which stent to perform biliary drainage in most common clinical settings, including in patients with a potentially resectable malignant biliary obstruction and in those who require palliative drainage of common bile duct or hilar strictures. Treatment of benign conditions (strictures related to chronic pancreatitis, liver transplantation, or cholecystectomy, and leaks and failed biliary stone extraction) and management of complications (including stent revision) are also discussed. A two-page executive summary of evidence statements and recommendations is provided. A separate Technology Review describes the models of biliary stents available and the stenting techniques, including advanced techniques such as insertion of multiple plastic stents, drainage of hilar strictures, retrieval of migrated stents and combined stenting in malignant biliary and duodenal obstructions.The target readership for the Clinical Guideline mostly includes digestive endoscopists, gastroenterologists, oncologists, radiologists, internists, and surgeons while the Technology Review should be most useful to endoscopists who perform biliary drainage.     

塑料与金属胆管支架的材料特征及其生物相容性

背景：经消化内镜塑料及金属胆管支架置入技术是治疗胆道良恶性梗阻的有效手段。尤其是高位梗阻胆管内支架置入治疗,对不能进行外科治疗的胆系肿瘤患者急需消除黄疸,顺应生理性引流,延长生存期,提高生活质量有极大的临床应用价值。目的：对比经消化内镜置入塑料及金属胆管支架治疗胆道良恶性梗阻的临床效果,并探讨塑料及金属胆管支架与宿主间的生物相容性。方法：由第一作者以＂胆道梗阻,塑料胆管支架,金属胆管支架,生物相容性＂为中文检索词,以＂cerebrovascular disease,stent,biocompartibility＂为英文检索词,在中国期刊全文数据库（CNKI：1989/2009）及Medline（1989/2009）数据库中采用电子检索的方式进行文献检索。排除Meta分析及重复性研究。筛选纳入35篇文献进行评价,探讨塑料及金属胆管支架的治疗现状、并发症和生物相容性。结果与结论：经内镜置入胆管支架是治疗胆道良恶性梗阻的主要手段。胆管内支架主要包括金属支架和塑料支架两种。金属支架在预防细菌滋生,保持支架持久通畅等方面有很大的优势,但价格昂贵。塑料支架较易细菌附着,胆泥淤积导致支架阻塞,但具有容易更换、价格低廉的优点。塑料及金属胆管支架的生物相容性均有待于提高,对于胆管恶性梗阻的患者,胆管内支架置入与放射治疗相结合有助于预防支架梗阻。对于胆泥的形成,支架的移位和堵塞,以及支架降解产物等问题尚需要进一步的观察和研究。     

Endoscopic removal of an embedded biliary Wallstent by piecemeal extraction

Expandable metal biliary stents are reserved for patients with unresectable malignant biliary obstruction. Occasionally, these stents may cause complications necessitating removal. We describe successful endoscopic removal of a biliary Wallstent one year after insertion in a patient who initially underwent placement of an expandable metal biliary stent for presumed biliary malignancy. The stent was removed after a stent related bleeding duodenal ulcer formed.     

Endoscopic retrograde cholangiopancreatography for distal malignant biliary stricture

Endoscopic biliary stent placement is widely accepted as palliation for malignant biliary obstruction or as a treatment of benign biliary stricture. Although various biliary stent designs have become available since self-expandable metallic stents were introduced, no single ideal stent has been developed. An ideal stent should be patent until death, or surgery, in patients with resectable malignant biliary obstruction. Fewer complications, maneuverability, cost-effectiveness, and removability are also important factors. Alternatively, should we develop a novel method for biliary drainage other than biliary stenting via endoscopic retrograde cholangiopancreatography? This article reviews the current status of biliary stenting for malignant biliary obstructions.     

New tapered metallic stent for unresectable malignant hilar bile duct obstruction

AIM: To examine the usefulness of a new tapered metallic stent(MS) in patients with unresectable malignant hilar bile duct obstruction.METHODS: This new tapered MS was placed in 11 patients with Bismuth Ⅱ or severer unresectable malignant hilar bile duct obstruction, as a prospective study. The subjects were six patients with bile duct carcinoma, three with gallbladder cancer, and two with metastatic bile duct obstruction. Stenosis morphology was Bismuth Ⅱ: 7, Ⅲa: 3, and Ⅳ: 1. UMIN Clinical Trial Registry(UMIN000004758).RESULTS: MS placement was 100%(11/11) successful. There were no procedural accidents. The mean patency period was 208.401 d, the median survival period was 142.000 d, and the mean survival period was 193.273 d. Occlusion rate was 36.4%(4/11); the causes of occlusion were ingrowth and overgrowth in 2 patients each, 18.2%, respectively. Patients with occlusion underwent endoscopic treatment one more time and all were treatable. CONCLUSION: The tapered MS proved useful in patients with unresectable malignant hilar bile duct obstruction because it provided a long patency period, enabled re-treatment by re-intervention, and no procedural accidents occurred.     

经内镜与经皮肝穿刺胆道金属支架置入治疗肝外胆管恶性梗阻的对比分析

【目的】探讨应用不同方式胆道金属支架置入治疗肝外胆管恶性梗阻的效果,为临床上选择更适当的方法治疗晚期恶性梗阻性黄疸提供依据。【方法】回顾性分析本院2009年1月至2013年1月经内镜胆道金属支架置入术（EMBD）治疗肝外胆管恶性梗阻患者80例（EMBD组）及经皮肝穿刺胆管造影（PTC）胆道金属支架置入术治疗肝外胆管恶性梗阻患者80例（PTC组）的临床资料。比较两组的手术成功率、术后并发症发生率、支架通畅时间及患者生存期。【结果】两组患者术后肝功能均有明显改善,两组之间比较总胆红素（TB）、碱性磷酸酶（ALP）及谷氨酰基转移酶（GGT）下降程度无显著性差异（P＞0．05）,PTC组的手术成功率高于 EMBD组,但并发症的发生率明显高于 EMBD组（P＜0．05）。两组病人术后支架通畅时间及生存期比较无显著性差异（P ＞0．05）。【结论】对于肝外胆道恶性梗阻患者可首选 EMBD,如手术失败可考虑经PTC途径行胆道支架置入。     

Expandable metal stents for malignant hilar biliary obstruction

Most patients with malignant hilar stenoses are candidates for palliation. For this purpose, biliary drainage plays a major role in improving liver function and managing or avoiding cholangitis. Endoscopic interventions are less invasive than the percutaneous approach and should be considered as the first-line drainage procedures in most cases. Transhepatic interventions should be reserved for endoscopic failures or performed as a complementary approach in a combined procedure. After successful endoscopic access to biliary obstruction, implantation of self-expandable metal stents offers advantages over plastic endoprostheses in terms of stent patency and number of reinterventions.     

A prospective randomized study of hydrophilic polymer-coated polyurethane versus polyethylene stents in distal malignant biliary obstruction

BACKGROUND AND STUDY AIMS: Hydrophilic polymer-coated polyurethane (HPCP) stents have a low friction coefficient and a hydrophilic layer, which may reduce biofilm formation and increase the period of stent patency. We compared the patency rates with this new stent with the standard Amsterdam-type polyethylene (PE) stent in a prospective randomized trial. PATIENTS AND METHODS: One hundred patients with an unresectable distal malignant bile duct stricture without a previous drainage procedure were randomly assigned to receive either a HPCP stent or a PE stent. The diameter (10 Fr), length (9 cm) and stent design (Amsterdam type) were similar in both stents. Nine patients were excluded. Forty-four patients received an HPCP stent and 47 patients a PE stent. The diagnoses included carcinoma of the pancreas (n = 78), papilla (n = 1), bile duct (n = 10), and metastases (n = 2). RESULTS: Stent insertion was successful in all patients. Stent dysfunction occurred in 27 of the HPCP stents and 20 of the PE stents, with median stent patency periods of 77 days (95 % CI, 53-101 days) for HPCP stents and 105 days (95 % CI, 42-168 days) for PE stents. The patency period was significantly longer for the PE stent (P = 0.04). Early complications occurred in four patients (4%), one in the HPCP group and three in the PE group. CONCLUSION: Hydrophilic polymer-coated polyurethane stents do not prolong the patency period of biliary stents. In fact, the current standard treatment using polyethylene stents in patients with distal malignant biliary obstruction showed a significantly longer patency period.     

Effectiveness of the Ultraflex Diamond stent for the palliation of malignant biliary obstruction

BACKGROUND AND STUDY AIMS: Endoscopically placed metallic biliary stents provide durable drainage for malignant biliary obstruction. The best-studied metal stent is the Wallstent, which has a greater duration of patency than polyethylene stents. Recently, the Ultraflex Diamond stent has been introduced, with reports from Europe which suggest efficacy similar to that of the Wallstent. We report our experience with this new metal stent and compare it with a historical cohort of Wallstent-treated patients. PATIENTS AND METHODS: Between July 1997 and July 1998 all metal stents placed for malignant biliary obstruction were Diamond stents (10 mm diameter, 6 or 8 cm length). Prospective follow-up details with regard to patient death or stent occlusion were obtained. In total, 32 patients underwent stenting, but 11 patients were excluded because of the following: death from pre-existing cholangitis (2); placement of bilateral hilar stents (2); placement of stent through occluded metal stents (3); failure to palliate jaundice due to complex hilar stricture (2) or concomitant liver failure (1); or inability to obtain follow-up (1), leaving 21 patients for analysis. Occlusion rates and stent patency were also determined retrospectively for 19 patients with malignant biliary obstruction who had Wallstents (10 mm diameter, 6.8 cm length) placed during the preceding year and for whom accurate and complete follow-up details were available. RESULTS: In the Diamond stent group there were 14 men and seven women, mean age 73. In the Wallstent group there were 11 men and eight women, mean age 66. The types of cancer, level of stricture and percentage with prior polyethylene stenting were similar in both groups. Stent occlusion occurred in 9/21 (43%), Diamond stents at a mean of 74 +/- 43 days compared with 8/19 (42%) Wallstents at a mean of 178 +/- 138 days (P < 0.04). Mean time of stent patency was 110 +/- 89 days for Diamond stents and 253 +/- 218 days for Wallstents (P < 0.01). Analysis of occlusion-free survival using a Kaplan-Meier plot showed a trend favoring the Wallstent (P = 0.12; Wilcoxon test). CONCLUSIONS: The occlusion rate and patency of Diamond stents for malignant biliary obstruction appear to be inferior to those of Wallstents and similar to reported values for polyethylene stents. Prospective randomized comparisons of Wallstents and newer self-expanding metal stents are warranted.     

Fractured metallic biliary stent causing obstruction and jejunal perforation

Interventional internal drainage of the biliary tract has become an established procedure for both the temporary and definitive treatment of biliary obstruction due to malignant or benign disease. Biliary stent migration and stent fracture are known but rare complications. A 50‐year‐old man presented with acute onset pain in the abdomen and vomiting. He had undergone hepaticojejunostomy following a bile duct injury during open cholecystectomy 13 years before he presented at our institution. Subsequently, he developed a benign biliary stricture at the anastomotic site, which was stented transhepatically by a metallic stent. CT of his abdomen showed a fractured stent segment obstructing the jejunum with a localized perforation. Herein, we discuss his presentation and course of management, and review the factors influencing stent migration and fracture and the potential options for stent retrieval. The patient needed surgical intervention to retrieve the migrated fragment of metal stent and to resect the perforated jejunal segment. The role of endoscopic self‐expanding metal stents for benign biliary disease remains controversial. A migrated stent that has become symptomatic should be removed endoscopically in early and accessible cases and surgically when endoscopic measures fail or when complicated by obstruction or perforation.     

Similar performance but higher cholecystitis rate with covered biliary stents: results from a prospective multicenter evaluation

BACKGROUND AND STUDY AIMS: Endoscopic biliary stenting is now a well-established treatment method in patients with unresectable malignant biliary obstruction. Despite advances with metal stents, the problem of stent occlusion has not yet been resolved. Covered metal stents could reduce the occlusion rate by preventing tumor ingrowth, but have not been well evaluated. A prospective multicenter study was therefore conducted to evaluate the efficacy and disadvantages of covered Wallstents. PATIENTS AND METHODS: Covered Wallstents were implanted endoscopically in 62 patients with inoperable distal malignant biliary obstruction. Complications, stent patency, and patient survival were analyzed. RESULTS: Stent insertion was achieved in 61 of the 62 patients (98.4 %). Procedure-related complications were observed in four patients, consisting of minor pancreatitis (n = 2) and abdominal pain due to stent expansion (n = 2). There was no procedure-related mortality. Seven patients died too early for proper assessment, so that a total of 54 patients were ultimately evaluated. Stent dysfunction occurred in 17 of the 54 patients (31.5 %). The reasons for dysfunction were proximal tumor overgrowth (n = 5), migration (n = 3), lithiasis or food impaction (n = 3), cholangitis without the need for a repeat biliary intervention (n = 5), and unknown (n = 1). The median period of stent patency was 142 days. No tumor ingrowth was observed. Acute cholecystitis was diagnosed in five patients (10 %) and was responsible for one death. Three stents were successfully removed. CONCLUSIONS: Covered biliary metal stents are effective for the drainage of distal malignant biliary obstruction, with a dysfunction rate apparently similar to that of uncovered stents. However, the risk of acute cholecystitis appears to be a major concern with this type of stent in patients with gallbladder in situ. Further comparative studies are needed.     

Endoscopic biliary drainage by nasobiliary drain or by stent placement in patients with acute cholangitis

BACKGROUND AND STUDY AIMS: Endoscopic biliary drainage is an established mode of treatment for acute cholangitis. We compared the safety and efficacy of nasobiliary drain (NBD) placement and stent placement for biliary drainage in patients with acute cholangitis. PATIENTS AND METHODS: We recruited a total of 150 patients with severe cholangitis who required endoscopic biliary drainage. Patients were randomized to have either a 7-Fr NBD or a 7-Fr straight flap stent placed during endoscopy. Outcome measures included complications related to endoscopic retrograde cholangiopancreatography (ERCP) and the clinical outcome. RESULTS: Of the 150 patients, 75 were randomized to the NBD group and 75 to the stent group. The most common causes of biliary obstruction were common bile duct stones (n = 102) and biliopancreatic malignancies (n = 37). The site of the biliary obstruction was predominantly found to be the lower part of common bile duct in both the NBD group (n = 58) and the stent group (n = 59). Indications for biliary drainage were: a fever of > 100.4 degrees F (n = 140), hypotension (n = 23), peritonism (n = 40), impaired consciousness (n = 29), and failure to improve with conservative management (n = 45). Biliary drainage was achieved in 147 patients. Abdominal pain, fever, jaundice, hypotension, peritonism and altered sensorium improved after a median period of 2 days in both groups. Leukocyte counts became normal after a median time of 7 days in the NBD group and 6 days in the stent group. There were no ERCP-related complications. There were no instances of displacement or kinking of an NBD, occlusion of an NBD or stent, or of stent migration. Four patients died (two in the NBD group and two in the stent group) as a result of uncontrolled cholangitis after 1, 2, 4, and 6 days of biliary drainage. The success rates of biliary drainage in cholangitis were not affected by the type of endoprosthesis used (72/74 for NBD patients vs. 71/73 for stent patients), the etiology of the biliary obstruction (110/112 for benign obstruction vs. 33/35 for malignant obstruction), or the site of the biliary obstruction (28/30 for upper common bile duct obstruction vs. 115/117 for obstruction at the lower end of common bile duct). CONCLUSIONS: Biliary drainage by nasobiliary drain and drainage by stent are equally safe and effective treatments for patients with severe cholangitis.     

经ERCP胆道金属支架植入治疗不可切除肝外胆道恶性梗阻的安全性及疗效评价

目的探讨经内镜逆行胰胆管造影(ERCP)胆道金属支架置入对于肝外胆道恶性梗阻的临床疗效及安全性。方法根据患者手术方法不同将40例恶性胆道梗阻患者分为经皮经肝胆管穿刺引流术(PTCD)组和ERCP组。PTCD组患者接受PTCD治疗,ERCP组患者接受ERCP置入金属支架治疗。结果两组生存时间差异有统计学意义(P0.05)。ERCP组术后胆道通畅时间明显长于PTCD组,差异有统计学意义(P0.05)。ERCP组住院时间明显少于PTCD组(P0.05)。术后1周ERCP组肝功能检测指标明显优于PTCD组(P0.05)。此外,PTCD组和ERCP组的并发症发生率分别30.0%与10.0%。ERCP组的并发症发生率明显低于PTCD组(P0.05)。结论 ERCP支架置入与PTCD解除胆道恶性梗阻疗效相似。但是,ERCP术后胆道通畅时间长,并发症少,患者肝功能指标恢复快。因此,对于肝外胆道恶性梗阻的患者,采用ERCP临床疗效更好,安全性更高。     

超声引导经皮肝胆道引流术治疗恶性胆道梗阻102例分析

目的 评价超声引导下经皮肝胆道引流术(PTCD)治疗恶性胆道梗阻的临床疗效。方法 对102例不能手术根治的恶性胆道梗阻患者行超声引导PTCD术。其中肝门部胆管阻塞(A组)68例，胆总管阻塞(B组)34例。内外引流57例，外引流45例。行左路术式88例，右路术式3例，左路 右路术式11例。A组中11例合并右肝管阻塞者行左路 右路术式的左右肝管双管外引流。102例中82例患者完整随访。结果 102例患者置管成功率100％，无1例出现胆漏、出血等穿刺并发症。A、B两组术后疗效优良率分别达到95．6％、100％。经十二指肠乳头的内外引流术较不经十二指肠乳头的内外引流术，术后胆道感染和胰腺炎的发生率明显增高。外引流和内外引流两种引流方式之间的疗效及生存率差异无显著性意义。PTCD换管次数与生存期呈正相关。结论 超声引导PTCD是姑息性治疗手术不能根治的恶性胆道梗阻的有效方法，超声引导左路术式的胆汁引流成功率高且安全，术后监控引流管引流通畅是提高生存期的关键。     

Endoscopic management of persistent biliary leakage resulting from complete transection of the bile duct at cholecystectomy

BACKGROUND AND STUDY AIMS: Injuries to the bile duct are not uncommon during cholecystectomy. While minor injuries are amenable to endoscopic therapy, major ones, such as complete transection of the duct, require surgical intervention. We report on the endoscopic management of such injuries. PATIENTS AND METHODS: We included in the study ten patients who had persistent postoperative bile drainage (either through a surgically placed catheter or through a biliocutaneous fistula) after their cholecystectomy procedure had been complicated by complete transection of the bile duct. Plastic biliary endoprostheses were placed in the bilioma through the papilla of Vater. In one patient, both the right and the left hepatic ducts were opacified by injecting contrast material through the drainage catheter and it was possible to place stents in both the ducts. RESULTS: All the patients improved clinically after the procedure. In one patient the stent became dislodged and an elective Roux-en-Y hepaticojejunostomy was performed, but it was possible to remove the stents from all the other patients. Two patients were referred for surgery but in both cases the bile flow through the bile duct was shown to be so good on nuclear imaging that they were not operated on. All the non-operated patients are well after a mean +/- SD follow-up of 22.3 +/- 5.5 months. CONCLUSIONS: Placement of biliary stents in the bilioma is a useful adjunct to percutaneous drainage in patients with complete transection of the bile duct. After placement of a biliary stent in the bilioma the percutaneous drainage catheter may be removed. In one of our study patients it was also possible to place stents in the intrahepatic ducts and the bile duct was reconstructed. Long-term follow-up of these patients and further studies are required to assess the role of endoscopic management as an alternative to surgery in patients with this condition.     

胆管内支架引流治疗良恶性胆管梗阻32例分析

目的探讨胆管内支架引流治疗良恶性胆管梗阻的效果。方法采用胆管内支架治疗良恶性胆管梗阻32例。结果置管成功率96.8%,引流总有效率为93.7%,并发症为3.1%。结论内镜置入胆管支架治疗胆管梗阻疗效确切,操作简单,成功率高,并发症少,可重复置管使用,是一种较好解除胆管梗阻的治疗方法。     

内镜逆行胰胆管造影下射频消融联合支架置入治疗胆道狭窄患者的护理

目的探讨内镜逆行胰胆管造影(endoscopic retrograde cholangio pancreatography,ERCP)下射频消融联合支架置入术治疗胆道狭窄患者的护理方法。方法回顾性分析2011年9月至2013年1月在第二军医大学东方肝胆外科医院内镜科治疗的24例恶性胆道梗阻患者的临床资料,患者均采用全身麻醉方式,实施ERCP下腔内射频消融联合胆道支架置入术。结果 24例患者均完成胆管内射频消融治疗,术后1周内黄疸基本缓解。术后3例患者并发胆管炎、1例患者并发轻度胰腺炎,均在给予对症治疗1周后治愈。随访期5~6个月,21例患者支架通畅,1例患者死于心脑血管意外。结论周密的术前准备可确保治疗顺利进行;术中熟练掌握配合要点和操作程序,可确保治疗安全;术后精心护理可使患者安全度过康复期。     

经内镜胆道金属支架引流术治疗恶性胆道梗阻性黄疸

目的:探讨经内镜胆道金属支架引流术治疗恶性胆道梗阻性黄疸的疗效和安全性。方法:42例无法行手术根治性切除的恶性胆道梗阻性黄疸患者采用内镜下胆道金属支架引流术治疗。并观察血清胆红素水平及术后并发症情况,随访患者生存期和胆道支架维持通畅时间。结果:42例患者放置胆道金属支架均获成功,成功率为100.0%(42/42);术后2周内血清胆红素恢复正常30例(71.4%),明显减退12例(28.6%);2例(4.8%)发生胆管炎,3例(7.1%)发生急性轻型胰腺炎;平均支架维持通畅时间为9.6个月;6个月和1年生存率分别为64.3%(27/42)和19.0%(8/42)。结论:经内镜胆道金属支架引流术治疗恶性胆道梗阻性黄疸疗效较好,并发症少。     

恶性胆道梗阻金属支架堵塞后再次置入金属和塑料支架的比较

背景：在堵塞的支架中再次置入金属或塑料支架可解决支架的堵寒问题,然而关于支架间如何搭配组合将使患者受益更大却一直存在着争论。目的：对比恶性胆道梗阻金属支架堵塞后再次在其内置入不同种类支架之间的临床效果。方法：收集在南昌大学第二附属医院行经内镜胆道金属支架置入的,且在原支架堵塞后再次在其内置入另一支架的中、低位胆道恶性梗阻患者83例,并根据原支架与再次置入支架的不同搭配组合形式,将以上患者分为3组,即覆膜金属支架组、无覆膜金属支架组和塑料支架组。结果与结论：在原金属支架堵塞后,再次置入覆膜金属支架的通畅时间显著长于塑料支架（P〈0．05）：覆膜金属支架组的支架累计通畅时间显著长于无覆膜金属支架组（P〈0．05—0．01）。提示经内镜置入胆道金属支架治疗中、低位胆道恶性梗阻时,在原金属支架和支架堵塞后再次置 入金属支架时．使用≥1根覆膜支架的累计通畅时间显著长于先后2次置入无覆膜金属支架者。     

恶性梗阻性黄疸76例介入治疗疗效分析

目的：探讨介入方式治疗恶性梗阻性黄疸（malignant obstructive jaundice,MOJ）的临床效果及价值。方法对76例MOJ患者行经皮肝穿刺胆管内支架置入术（percutaneous transhepatic insertion of biliary stent,PTIBS）,术后35例患者联合介入方法抗肿瘤综合治疗。结果76例MOJ患者均成功置入金属胆道支架,共置入金属胆道支架102枚。根据患者不同的梗阻类型置入支架放置部位不同,30例肝门部置入金属胆道支架共56枚（26例置入双支架）,34例胆总管部置入支架共34枚,12例壶腹部置入支架12枚。术后2周复查血清总胆红素（TBIL）、直接胆红素（DBIL）及谷丙转氨酶（ALT）,进行独立样本t检验,P值均〈0.05。随访74例患者（失访2例）,PTIBS术后是否行介入抗肿瘤治疗患者的生存时间及支架的通畅时间进行卡方检验,P值均〈0.05。结论 PTIBS技术成功率高,退黄效果明显。PTIBS结合介入方式进行抗肿瘤治疗,可延长患者的生存时间及支架的通畅时间。