Endoscopic stent placement in the palliation of malignant biliary obstruction

Biliary drainage with biliary stent placement is the treatment of choice for palliation in patients with malignant biliary obstruction caused by unresectable neoplasms. In such patients, the endoscopic approach can be initially used with percutaneous radiological intervention. In patients with unresectable malignant distal bile duct obstructions, endoscopic biliary drainage with biliary stent placement has now become the main and least invasive palliative modality, which has been proven to be more effective in >80% of cases with lower morbidity than surgery, and perhaps may provide a survival benefit. In patients with unresectable malignant hilar obstruction, the endoscopic approach for biliary drainage with biliary stent placement has also been considered as the treatment of choice. There is still a lack of clear consensus on the use of covered versus uncovered metal stents in malignant distal bile duct obstructions and plastic versus metal stents and unilateral versus bilateral drainage in malignant hilar obstructions.     

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。     

胆管支架材料及类型对置入效果的影响:改善开通率和延长开通时间

背景:胆管内支架有可膨胀式金属支架和塑料内涵管两种,前者的开通时间比后者长,但进口品价格昂贵,故对选择金属支架还是塑料内涵管存在争议.因此,如何选择适宜的支架,改善支架的开通率和延长支架的开通时间,是目前医学界研究的热点.目的:阐述胆管支架的临床应用进展,并探讨胆管支架的材料、类型对置入后支架开通率及开通时间的影响.方法:作者以"胆管内支架,金属支架,塑料支架,阻塞,再狭窄"为检索词,在中国期刊全文数据通信(CNKI:2002/2008)及Medline数据库(Pubmed:1974/2006)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,共检索到20篇文献,从胆管支架置入治疗进展,不同材料及类型胆管支架对开通率、开通时间的影响,以及预防支架梗阻等方面进行探讨.结果与结论:胆管内支架置入是恶性胆管梗阻姑息治疗的最佳方法,并发症少.胆管内支架主要包括金属支架和塑料支架,两种支架的生物相容性均有待提高.金属支架在预防细菌滋生,保持支架较久通畅方面较塑料支架有很大优势,但价格昂贵:塑料胆管支架较易发生细菌附着、胆泥淤积导致支架阻塞,但具有易于更换、价格低廉等优点.肝内胆管支架与各种放射疗法的联合应用均可延长支架的有效开通期限,并有效的防治支架梗阻.提示胆管支架置入是临床治疗良恶性胆道狭窄的最有效手段,胆管内支架置入和放射疗法相结合可预防支架梗阻.     

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.     

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.     

Plastic biliary stents for benign biliary diseases

Biliary plastic stenting plays a key role in the endoscopic management of benign biliary diseases. Complications following surgery of the biliary tract and liver transplantation are amenable to endoscopic treatment by plastic stenting. Insertion of an increasing number of plastic stents is currently the method of choice to treat postoperative biliary strictures. Benign biliary strictures secondary to chronic pancreatitis or primary sclerosing cholangitis may benefit from plastic stenting in select cases. There is a role for plastic stent placement in nonoperative candidates with acute cholecystitis and in patients with irretrievable bile duct stones.     

High complication rate of bile duct stents in patients with chronic alcoholic pancreatitis due to noncompliance

BACKGROUND AND STUDY AIMS: Biliary obstruction in chronic pancreatitis is frequently treated by endoscopic insertion of a plastic stent into the common bile duct, a therapy regarded as having a low complication rate. The aim of this study is to analyze the frequency and severity of complications caused by biliary stents in patients with chronic alcoholic pancreatitis. PATIENTS AND METHODS: We retrospectively analyzed all our patients with chronic pancreatitis (n = 14) who were provided with a plastic stent for biliary stenosis between June 1993 and December 1997. Stent exchanges were followed until December 1998. RESULTS: Stent insertion was performed without early complications and was successful in each patient. Only two patients were admitted after 3-4 months at the scheduled dates for stent exchange, both without complications. In one of these patients, the bile duct stenosis was reopened after two stent exchanges over a total period of 8 months. Most of our patients (n=12) did not come at the arranged dates for stent exchange. They were repeatedly admitted (mean 2.9 times/patient, range 1-5) as emergency cases with severe complications of biliary obstruction, such as cholangitis or biliary sepsis. Reopening of the bile duct stenosis was not achieved in these patients. CONCLUSIONS: We associate the high rate of complications with the noncompliance of our patients, who were all alcoholics. The high incidence of late complications in noncompliant patients is a limitation of biliary stenting, and appears to be potentially harmful.     

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.     

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.     

Percutaneous insertion of Zilver stent in malignant biliary obstruction

Background We evaluated the clinical efficacy and technical feasibility of the percutaneously inserted self-expandable nitinol stent (Zilver stent) for palliation of malignant biliary obstruction. Methods Seventeen patients with malignant tumors involving the intra- or extrahepatic bile duct who presented with obstructive jaundice underwent percutaneous insertion of a self-expandable nitinol stent. We retrospectively reviewed the hospital records of patients and evaluated the technical feasibility on stent placement, complications, patient survival, and duration of stent patency. Results Percutaneous biliary stenting with 27 Zilver stents was performed in 17 patients with malignant biliary obstruction. Technical success was 95%. Malposition of the stent was encountered in one patient. Minor technical problems were encountered in two patients: the introducer tip was broken during stent insertion, so endoscopic removal was done. Mean follow-up period for the 17 patients was 182 days (range 29–485 days): nine patients died of progressive disease at a mean follow-up of 151 days (range 61–371days) after stent insertion and eight patients remained alive at the final follow-up of 216 days (range 29–485 days). The median survival period for all patients was 277 days. The stent occlusion rate was 26% and the mean patency period was 280 days. In five patients, seven stents were obstructed by tumor ingrowth and overgrowth. Stent patency rates were 100%, 100%, 75%, 61%, and 41% at 1, 2, 3, 6, and 12 months, respectively. A late complication, erosive bleeding of the hepatic artery by the stent, developed in one patient. Conclusion Percutaneous biliary stenting using the nitinol stent is technically feasible and safe and clinically efficacious treatment for malignant biliary obstruction, even with a minor technical problem during stent insertion.     

A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures

BACKGROUND AND STUDY AIMS: Endoscopic biliary stenting is an established treatment for malignant obstructive jaundice. Stent clogging continues to be a major problem with plastic stents. The aim of this study was to carry out a prospective comparison of two stents with different materials and shapes: the Olympus DoubleLayer stent (DLS; perfluoro alkoxy, without sideholes) and the standard polyethylene (PE) stent (with sideholes). PATIENTS AND METHODS: A total of 120 patients (70 women; mean age 71, range 36 - 91) with jaundice due to malignant strictures of the middle to distal third of the common bile duct were randomly assigned to receive either DLS (n = 60) or PE (n = 60) biliary stents. Patients with cholangitis, hemobilia, previous biliary drainage, hilar stricture, or ampullary cancer were excluded. RESULTS: In all, 28 DLS patients (47 %) and 17 PE stent patients (29 %) died without clinical evidence of stent occlusion after a mean of 114 and 105 days, respectively ( P < 0.05). Twenty-six DLS patients (43 %) and 38 PE stent patients (63 %) had symptoms of stent clogging after a mean of 144 and 99 days, respectively ( P < 0.05). Stent dysfunction (stent orifice impacted on the bile duct or duodenal wall, stent migration) was recorded in six DLS patients (10 %) and five PE patients (8 %) (n. s.). Kaplan-Meier analysis of DLS and PE stent clogging-free survival showed a significantly longer patency period with the DLS stents (P = 0.0005). CONCLUSIONS: These results show that DoubleLayer stents have a longer patency period than PE stents. Patients who received PE stents had a higher risk of stent occlusion (relative risk 3.05; 95 % CI, 1.57 - 5.89) before death than DLS patients.     

Extrahepatic bile duct stricture and elevated CA 19-9: malignant or benign?

Biliary obstruction due to a proximal bile duct stricture is commonly a result of cholangiocarcinoma. We describe a patient who began having intermittent episodes of jaundice 3 years after cholecystectomy. Despite endoscopic placement of a biliary stent and adequate biliary decompression, the serum CA 19-9 level remained elevated at 58 U/ml (normal <37 U/ml). Segmental bile duct resection and Roux-en-Y hepaticojejunostomy were done. The stricture was caused by a traumatic bile duct neuroma. Diagnostic and therapeutic considerations of this entity are discussed, with special emphasis on the value of noninvasive biliary imaging by magnetic resonance imaging (MRI), the utility and interpretation of the CA 19-9 level, and the role for resection or surgical biliary decompression.     

Endoscopic placement of expandable metal stents for biliary strictures--a preliminary report on experience with 33 patients

The main problem with palliative treatment of extrahepatic cholestasis with an endoscopic biliary endoprosthesis is clogging. One of the factors thought to be of importance is the diameter of the stent. In order to avoid being limited by the size of the instrumentation channel of the endoscope, expandable stents have been developed. In this article we report on our preliminary clinical experience with an endoscopically placed expandable metal stent ("Wallstent") in 33 patients with extrahepatic bile duct stenoses. When fully expanded, the stent has a diameter of 30 F and a length of 6.7 cm. It was possible to successfully place a stent in every patient. Clinical improvement was achieved in all patients except one. Two patients underwent elective surgery, while one died of renal failure. Another died of septic shock after 5 weeks, but no autopsy was performed. In conclusion, our initial experience with this stent shows that at least in the short term biliary drainage was excellent, with no complications of pancreatitis or hemorrhage. Longer follow-up than our 4 weeks is necessary to establish the position of this stent in comparison with the conventional endoprosthesis in the management of obstructive jaundice.     

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。     

Obstructive jaundice due to isolated tuberculosis of the pancreas: endoscopic treatment instead of surgery?

The optimal treatment for relieving biliary obstruction due to isolated pancreatic tuberculosis has not so far been defined, and most previously reported patients were treated surgically. We describe a 17-year-old, immunocompetent girl who was admitted with obstructive jaundice caused by a tuberculous mass in the head of the pancreas. Antituberculous therapy alone failed to alleviate the jaundice, and she was therefore treated by stent insertion and, subsequently, balloon dilation of the common bile duct stricture. At follow-up 5 years later, magnetic resonance cholangiopancreatography showed no evidence of stricture in the common bile duct.     

老年肝门部胆管癌围手术期处理与手术治疗

目的：探讨老年肝门部胆管癌围手术期处理与手术治疗方法.方法：回顾性分析解放军总医院肝胆外科1993-01～2004-12收治的120例老年性肝门部胆管癌手术患者的临床资料.结果：120例手术患者中,根治性切除37例,姑息性切除35例,胆管引流45例,其他手术3例.术后37例（30.8%）出现并发症,大多为胆汁瘘与腹水,死亡1例（0.8%）,死于术后肝肾功能衰竭,余治愈出院.结论：加强围手术期处理,选择合理手术方式,可提高手术的安全性,使术后恢复顺利.     

To stent or not to stent: an evidence-based approach to palliative procedures at the end of life

Patients near the end of life often undergo invasive procedures, such as biliary stenting for obstructive jaundice, with the intent of relieving symptoms. We describe a case in which the medical team and a patient and family are considering a second palliative biliary stent despite the patient's limited life expectancy. We review available evidence to inform the decision, focusing on the specific question of whether the benefits of palliative biliary stents in patients with advanced cancer outweigh the risks. We then apply the evidence to the issue of how the primary and/or palliative care team and the interventionist communicate with patients and their families about the risks and benefits of palliative procedures. Review of the evidence found several prospective case series without control groups that measured patient-centered outcomes. Studies had high attrition rates, results for improvements in symptoms and quality of life were mixed, and rates of complications and short-term mortality were high. In conclusion, the limited evidence does not support that the benefits of palliative biliary stents in this population outweigh the risks. We propose that primary care teams consider and discuss the larger picture of the goals of care with patients and families when considering offering these procedures, as well as benefits and potential harms, and consider involving palliative care services early, before consultation with an interventionist.     

The treatment of patients with symptomatic common bile duct stenosis secondary to chronic pancreatitis using partially covered metal stents: a pilot study

BACKGROUND AND STUDY AIMS: Although surgery remains the gold standard for the treatment of symptomatic common bile duct stenosis associated with chronic pancreatitis, plastic and self-expandable open-mesh stents have been proposed as alternative treatments. These may dysfunction, however, mainly due to stent occlusion by clogging or by hyperplasia of inflammatory tissue. The aim of this study was to evaluate the safety and long-term results of using partially covered metal stents in this setting. PATIENTS AND METHODS: A total of 14 patients (12 men, 2 women; mean age 50 +/- 3 years) underwent partially covered metal stent insertion for common bile duct stenosis secondary to chronic pancreatitis (12 alcohol-related, two idiopathic). They had all been treated previously with plastic prostheses. RESULTS: Either a 40-mm (n = 13) or a 60-mm (n = 1) partially covered metal stent was placed, depending on the length of the common bile duct stenosis and the level of the cystic duct bifurcation. Stent placement was successful, with resolution of cholangitis and improvement in cholestasis, in all patients. During the median follow-up period of 22 months (range 12 - 33 months) seven patients developed dysfunction of the stent and required re-treatment. At 12, 24, and 30 months, the stent patency rates were 100 %, 40 %, and 37.5 % respectively. CONCLUSIONS: While partially covered metal stenting is safe and effective for the initial treatment of chronic pancreatitis-associated common bile duct stenosis and shows promising short-term results, long-term data show that dysfunction occurs in 50 % of cases. In light of the continued interest in nonsurgical treatment of this condition, further research is warranted to investigate new stent designs with improved long-term patency.     

Biliary stents

Endoscopically implantable stents are today the mainstay for therapy of biliary stenoses. It is important to know if a benign or a malignant stenosis is the cause of the biliary obstruction. Generally benign stenoses are treated with plastic-stents whereas malignant stenoses are managed by implantation of a metallic stent. The main indications for plastic stents are postoperative strictures in the biliary tree for example, after biliary tract surgery or liver transplantation, primary sclerosing cholangitis and postoperative biliary leakage. Metallic stents are implanted in palliative circumstances like in stenosing cholangiocarcinoma or in situations where a hepatic metastasis exerts an extrinsic compression on the biliary tract with consecutive cholestasis. The materials used for manufacturing both stent types are biologically inert and thus biocompatible. A current poorly resolved problem is the occlusion of the stent lumen (by sludge, bacterial degradation products etc.) which occurs in both stent types with time. These problems lead to stentocclusion around three to six months after implantation and necessitate endoscopical re-interventions in order to overcome the occlusion. The patency rate for metallic stents is better than for plastic ones. The endoscopic stenttherapy is equivalent to surgical therapy (Intestinal bypass-procedures).     

Endoscopic palliation of pancreaticobiliary malignancies

The palliation of pancreaticobiliary malignancies has changed over the last two decades. With the development of biliary stents, minimally invasive procedures have replaced surgical techniques. Endoscopically placed stents remain the mainstay for the palliative treatment of malignant biliary obstruction from unresectable pancreaticobiliary tumors. Further improvements in stent designs and advances in other endoscopic technologies are expected, and these should expand the role of minimally invasive palliation. This article reviews the current and anticipated roles of endoscopic techniques in the palliation of pancreaticobiliary malignancies.