应用自膨式金属支架姑息治疗无法手术的恶性梗阻性黄疸

目的 评价自膨式金属支架植入成形术治疗无法手术的恶性梗阻性黄疸及临床疗效.方法 对105例无法手术治疗的恶性梗阻性黄疸患者行胆道内支架成形术,术后随访3～755天,观察患者的临床症状改善情况及支架通畅情况.结果 共植入支架129枚,初次治疗的技术成功率为94.3%,78%患者术后达到临床显效的标准.术后30天患者死亡率为7.6%(8/105),死因均与介入操作无关.术后患者的中位生存期为189天,支架中位通畅时间为246天.术后3、6个月的支架通畅率分别为92.1%和64.5%.结论 自膨式金属支架植入术是姑息治疗恶性梗阻性黄疸的有效方法,准确判断无法从胆道支架成形术中获益患者将有助于改善支架成形术后的远期疗效.     

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.     

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 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.     

Diamond stents for palliation of malignant bile duct obstruction: a prospective multicenter evaluation

BACKGROUND AND STUDY AIMS: Various types of self-expandable metal stents have been introduced for biliary drainage in patients with malignant jaundice, showing prolonged patency compared with plastic endoprostheses. However, there has only been prolonged experience with a meaningful number of patients using the Wallstent. We evaluated the Diamond stent, a self-expanding uncoated biliary metal stent, in a prospective uncontrolled multicenter setting. PATIENTS AND METHODS: The eligibility criterion was obstructive jaundice due to inoperable malignant disease. Between August 1995 and January 2000, 126 patients, who received a total of 134 Diamond stents in four European centers, were followed prospectively. RESULTS: Technical and clinical success rates were 96 % and 98 %, respectively. No major procedure-related complications occurred. The 30-day mortality rate was 13 %. Stent occlusion occurred in 28 patients (22 %). Overall median stent patency was 477 days; overall median survival was 173 days. Stent occlusion, confirmed by endoscopic retrograde cholangiopancreatography, was successfully treated with plastic stents in all patients. Cost analysis revealed estimated costs of 3440 euros per patient for palliative treatment with the Diamond stent. CONCLUSIONS: The Diamond stent compares favorably with other biliary metal stents for patients requiring biliary drainage of malignant jaundice.     

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.     

Endoscopic removal of biliary self-expandable metallic stents: a prospective study

BACKGROUND AND STUDY AIMS: The transpapillary endoscopic insertion of self-expandable metallic stents (SEMSs) has been widely used for the palliation of unresectable malignant biliary obstruction. We attempted the endoscopic removal of malfunctioning SEMSs. The aim of this study was to assess the feasibility and safety of the endoscopic removal of SEMSs by comparing the results between removal of covered and uncovered SEMSs. PATIENTS AND METHODS: 30 patients with a malfunctioning biliary SEMS prospectively underwent an attempt at endoscopic removal of the biliary SEMS over a 2-year period. Removal of the malfunctioning SEMS was done with a therapeutic duodenoscope (ED-450XT5 or TJF-240), using a rat-tooth forceps. Of the 30 SEMS used, 22 were silicone-covered Wallstents, while eight were uncovered SEMSs including five uncovered Wallstents and three Zilver stents. The time for an attempt at each endoscopic removal was limited to 15 minutes in a single endoscopic procedure session. RESULTS: The covered SEMSs were easily removed in 19 out of 22 patients (86.4 %), whereas none of the eight uncovered SEMSs (0 %) could be removed. The only factor predicting successful stent removal was the presence of a stent covering ( P = 0.000). There was no morbidity or mortality related to endoscopic removal of malfunctioning stents. CONCLUSIONS: In contrast to uncovered biliary SEMSs, in most cases malfunctioning covered biliary SEMSs can be easily and safely removed endoscopically using a rat-tooth forceps.     

胆道内支架置入术治疗恶性梗阻性黄疸的疗效分析

目的 探讨经皮肝胆道内支架置入治疗恶性梗阻性黄疸的疗效及并发症。方法 对32例恶性梗阻性黄疸患者经皮肝穿胆道内行支架置入术,其中28例为内涵管,4例为金属内支架。随访35－376天,观察近中期疗效和并发症。结果 经皮肝胆道内支架置入术技术成功率为100％,置入术后1周血总胆红素水平较置入前明显下降（P＜0.001)。开通时间平均为101天,半年开通率为56.25%,并发症发生率24.98%,为主要包括胰腺炎和逆行胆道感染等。结论 经皮肝胆管内架置入术疗效可靠,是一种安全,可作为恶性胆管阻塞介入治疗的一种姑息性疗法。     

可膨式金属胆道支架在肝门部胆管癌的临床应用及疗效

目的探讨可膨式金属胆道支架对肝门部胆管癌的疗效及影响因素。方法32例肝门部胆管癌患者先通过内镜下逆行胰胆管造影（E1KCP）放置可膨式金属胆道支架，E1KCP不成功则通过经皮经肝胆道引流（PTCD）窦道放置。观察其操作成功率、退黄效果、并发症发生情况、支架通畅期及患者生存期。结果32例患者中28例均成功通过E1KCP置入可膨式金属支架，3例改行PTCD后再经窦道放入金属支架，成功率96．88％。1例行两种处理方法均未能成功；所有患者术后黄疸明显减退；3例患者支架再次阻塞，1例患者反复发作胆管炎。并发症发生率为12．5％；支架平均通畅期为213d，患者平均生存期为235d。结论可膨式金属胆道支架创伤小，通畅性能好，可作为无法手术切除或不愿手术的肝门部胆管癌患者的首选治疗方法。     

Application of resonance metallic stents for malignant ureteral obstruction

Abstract

Purpose: To determine the effectiveness of the Resonance metallic stent in treating malignant ureteral obstruction (MUO) and clarify the risk factors that lead to stent failure.

Material and methods: We retrospectively identified and analyzed the records of patients who had MUO and underwent placement of Resonance metallic stents from November 2014 to June 2017 in our hospital. Stent failure was defined as unexpected interventions including stent exchange, need of percutaneous nephrostomies (PCN) or ureterocutaneostomy.

Results: A total of 22 stents were placed in 14 patients with MUO. The median follow-up was 145?days (4.8?months) and the maximum duration of stenting was 21.3?months. The technique success rate was 100%. Two patients experienced early postoperative increasing creatinine with oliguria but only one of them failed to achieve primary patency. The overall success rate was 90% (9/10).

Conclusion: Resonance metallic stent is a safe and effective treatment for MUO and can maintain durable patency over 12?months. Preoperative urinary tract infection (UTI) and tumor invasion into the bladder are considered as risk factors of stent blockage and failure. Early postoperative elevated creatinine oliguria, suggestive with intrarenal and prerenal disease, should not be deemed to be stent failure.     

Biliary stents: models and methods for endoscopic stenting

Biliary stenting is widely used to palliate malignant obstruction or to treat benign biliary diseases. Recently, the most important changes have related to self-expandable metal stents (SEMSs), which are now available in a wide variety of designs, and to treatment techniques. This article is part of a combined publication that expresses the current view of the European Society of Gastrointestinal Endoscopy (ESGE) about endoscopic biliary stenting: a technology review describes the stent models and stenting techniques, and a separate clinical guideline states the evidence and recommendations regarding stenting.     

症状性颈动脉狭窄的血管内支架治疗

目的探讨血管内支架置放术治疗症状性颈动脉狭窄的临床效果。方法对35例颈动脉狭窄>70%的患者行血管内自膨式支架置放术,术中选用保护装置27例,行球囊预扩22例,行后扩5例。结果全部患者操作顺利,共置放支架42枚,影像学评价残余狭窄<20%。临床治愈29例,好转6例。随访1～36个月,症状无复发,无再狭窄。结论血管内支架置放术是治疗症状性颈动脉狭窄的一种有效方法,术后再狭窄有待于长期随访。     

覆膜和裸金属支架姑息性治疗远端恶性胆管梗阻的 meta分析

目的 对比自体膨胀式覆膜金属支架（CSEMS）与自体膨胀式裸金属支架（USEMS）姑息性治疗远端恶性胆管梗阻的利与弊。方法 检索MEDLINE、EMBASE、Cochrane Library、web of knowledge、CBM、CNKI、VIP和万方数据库。纳入从1994年1月—2013年5月发表的比较CSEMS与USEMS的随机对照实验（RCT）并进行文献质量评价。运用RevMan 5.2软件对其进行meta分析。结果 12个RCT符合研究标准,包含1 296个研究对象。CSEMS与USEMS在置入后3、6及12月支架通畅率比较差异无显著性（P＞0.05）。两组发生胰腺炎、胆囊炎、胆管炎、穿孔、出血、复发胆管梗阻及病人住院时间与生存期方面比较差异无显著性（P＞0.05）。与USEMS相比,CSEMS肿瘤长入的概率显著降低（OR=0.15;95% CI 0.05-0.45;P〈0.01）,但肿瘤过度生长的概率显著增高（OR=1.87;95% CI 1.06-3.30;P〈0.05）,更易发生支架移位（OR=9.91;95% CI 2.98-32.95;P〈0.01）。结论 与USEMS相比,CSEMS能够显著降低远端胆管恶性梗阻病人肿瘤长入的概率,但提高了肿瘤过度生长及支架移位的概率。CSEMS未能提高支架在3、6及12月的通畅率,也不能延长病人的生存时间,未能降低病人发生并发症的概率。     

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.     

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.     

单猪尾抗反流可回收塑料支架在恶性胆道梗阻性疾病中的应用

目的在恶性胆道梗阻性疾病中,尤其是高位胆道梗阻性疾病,研制出减黄效果好、反流发生率及梗阻率低、便于回收的单猪尾抗反流可回收塑料支架。方法对该院34例于2017年2月1日-2019年1月31日因高位恶性胆道梗阻性疾病接受经十二指肠镜置入胆道支架治疗的患者进行分析。共置入塑料胆道支架40个,24例患者仅置入1个普通塑料支架,4例患者仅置入1个单猪尾塑料支架,6例患者各置入1个普通塑料支架后发生梗阻,更换为单猪尾塑料支架。术后随访,比较患者肝功能变化情况、反流发生率及梗阻发生率。结果①采用新型单猪尾塑料支架治疗高位恶性胆道梗阻性疾病,术后的肝功能指标、反流发生率及梗阻发生率与普通塑料支架相比,差异均有统计学意义(P<0.05);②同一患者先后分别置入普通塑料支架及单猪尾塑料支架,术后的肝功能指标、反流发生率和梗阻发生率比较,差异均有统计学意义(P<0.05)。结论单猪尾塑料胆道支架置入术后减黄效果好,反流发生率和梗阻率低,且支架更便于回收,是恶性胆道梗阻性疾病患者,尤其是高位胆道梗阻患者支架置入的更佳选择。     

Biliary stent occlusion--a problem solved with self-expanding metal stents? European Wallstent Study Group.

The main limitation in the endoscopic palliation of malignant biliary obstruction is due to stent blockage. One of the factors thought to be of importance is the diameter of the endoprosthesis. In this paper, we report the results of a multicenter European study with a one cm diameter self-expanding metal stent (Wallstent) in 103 patients with malignant biliary obstruction. Insertion of the stent following guidewire positioning was successful in 97.1% of the patients without any cases of de novo cholangitis developing after the endoscopic procedure. The median follow-up for the entire group was 145 days. In all but 3 patients, the stent expanded to more than 80% of its maximum diameter. Two patients had ongoing cholangitis after stent insertion. Long-term complications manifested by late cholangitis, were seen in 18% of the cases after a median interval of 125 days. The occlusion rate by biliary sludge was 5% after a median time period of 175 days which is substantially less than the 21% occlusion rate reported for polyethylene stents. In conclusion, our results show that the Wallstent can be easily placed in distal and mid-CBD strictures after guidewire passage, with most of the patients having a- good drainage effect. The occlusion rate by biliary sludge is significantly less than for conventional polyethylene stents, but the occlusion by tumor ingrowth is substantial. A disadvantage is the high cost of the Wallstent. Further randomized trials will be required to determine the cost-benefit ratio for the use of this stent.     

A new self-expanding nitinol stent (JoStent SelfX) for palliation of malignant biliary obstruction: a pilot study

BACKGROUND AND STUDY AIMS: The JoStent SelfX is a new biliary uncovered self-expanding nitinol stent. The main advantage of this stent in comparison with the "gold standard" Wallstent is the minimal shortening (< 10 %) that occurs during stent deployment. A prospective feasibility study was conducted to evaluate the method of stent implantation and the stent's short-term efficacy. PATIENTS AND METHODS: Between April 2001 and December 2002, the JoStent SelfX was implanted in 20 patients with inoperable malignant biliary obstructions, mainly caused by pancreatic cancer (12 of 20). All patients underwent sphincterotomy prior to stent insertion. After implantation, laboratory parameters for cholestasis and expansion of the stent were checked over a period of several days. All patients were followed for 8 weeks after implantation to document early stent dysfunction. RESULTS: Stent implantation was easily managed and successful in all patients, with no technical problems. Prior bougienage was required in only one patient, who had a filiform stenosis. No stent retraction was observed during stent release. All stents showed full expansion within 5 days. No acute complications occurred. Adequate reduction in the elevated laboratory parameters for cholestasis was observed. Two patients had recurrent cholestasis and fever due to cholangitis, or stent occlusion caused by biliary sludge within 4 weeks. CONCLUSIONS: This new biliary metal stent is easily inserted and does not shorten during stent release, allowing precise positioning. No acute complications occurred, but there were two cases of early stent dysfunction. The role of the JoStent SelfX in comparison with other biliary stents will need to be evaluated in a multicenter trial with a larger number of patients, to investigate the long-term results.     

侧视内镜联合X线置入胃十二指肠及空肠金属支架治疗消化道恶性梗阻的临床观察

目的探讨侧视内镜联合X线监视下肠道金属支架置入,治疗胃出口、十二指肠及空肠恶性梗阻的临床价值。方法回顾性分析23例胃出口、十二指肠及空肠恶性梗阻部位与肠腔严重成角的患者。经十二指肠侧视内镜置入导丝,联合X线监视下置入并释放自膨式肠道金属支架。结果 23例患者共置入金属支架28枚,全部成功。其中5例因肿瘤生长至再狭窄,而再次置入半覆膜金属支架。置入成功率100.0%。1例胆道支架后再放置十二指肠支架的患者出现一过性胆红素升高,未发生消化道穿孔及其他严重并发症。所有患者支架置入后24 h梗阻症状缓解或消除。随访时间3～12个月,所有患者均保持支架通畅。结论侧视内镜联合X线放置胃十二指肠及空肠金属支架,较前视内镜联合X线方法对恶性梗阻部位与肠腔严重成角的患者置入难度及风险减轻,成功率高,操作精准,并发症少。     

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.