Expandable metal stents for benign biliary disease

Benign biliary diseases include benign biliary strictures (BBS), choledocholithiasis, and leaks. BBS encompass postoperative injury, anastomotic stricture, chronic pancreatitis, primary sclerosing cholangitis, and gallstone-related stricture. Therapeutic options for benign biliary diseases include surgical, percutaneous, and endoscopic interventions. Endoscopic options include placement of plastic stents as well as self-expanding metal stents (SEMS). SEMS can be uncovered, partially covered, and fully covered, and have been used with some success in resolution of strictures and leaks; however, complications limit their use. This article reviews the currently published experience on SEMS and attempts to define their current role in the treatment of benign biliary diseases.     

Endoscopic ultrasound-guided drainage of pancreatic fluid collections with indeterminate adherence using temporary covered metal stents

Transenteric drainage of a pancreatic fluid collection (PFC) with poor adherence to the bowel wall risks leakage and perforation. Elimination of tract dilation and the use of a fully covered self-expanding metal stent (FCSEMS) may improve safety. We evaluated endoscopic ultrasound (EUS)-guided drainage of PFCs using a one-step access device followed by placement of a FCSEMS. Eighteen patients (12 males; median age 50) with PFCs (median size 135 mm) meeting the criteria for indeterminate adherence were enrolled. After 7 - 10 days, the FCSEMSs were removed and exchanged for double-pigtail stents. When indicated, tract dilation and endoscopy-guided cyst debridement was performed. FCSEMS placement was technically successful in all patients without complications. Median procedure time was 37.5 minutes. Cystgastrostomy dilation resulted in dehiscence in one patient and was treated with repeat FCSEMS placement. Cyst resolution was achieved in 78 % of patients. FCSEMS placement without tract dilation enables safe initial drainage of PFCs with indeterminate adherence.     

Removable fully covered self-expandable metal stents in the treatment of common bile duct strictures due to chronic pancreatitis: a case series

The aim of this study was to test the removability of fully covered self-expandable metal stents (FCSEMS) in patients with a benign common bile duct (CBD) stricture. A FCSEMS was inserted in six patients with a CBD stricture due to chronic pancreatitis who were considered to be unfit for surgery, and stent removal was attempted after predefined intervals of 4 and 6 months. FCSEMS were successfully placed in all patients (100 % placement success) and stent extraction was accomplished in four patients (66 % removal rate), all of whom achieved stricture resolution (66 % resolution rate). In one patient a recurrent stenosis developed after 6 months (recurrence rate 25 %). Proximal stent migration occurred in two patients. In conclusion, FCSEMS removal was possible in the majority of patients and results regarding stricture dilation were promising. Nevertheless, before FCSEMS can become an acceptable treatment option for benign CBD strictures, innovative stent design modifications are necessary and removability must be ascertained.     

Esophageal perforation due to removal of partially covered self-expanding metal stents placed for a benign perforation or leak

Benign esophageal perforations and anastomotic leaks can be effectively managed by stent placement. However, when partially covered self-expanding metal stents (SEMS) are used, safe removal may be complicated. In this case series, we evaluated the complicated removal of SEMS placed for a benign esophageal perforation or leak in four patients. In all patients a partially covered SEMS was placed. After a median stent time of 29 days (range 21 - 30), the SEMS were found to have become embedded in the esophageal wall. Endoscopic removal resulted in perforation in all patients. All patients recovered uneventfully, although one patient underwent esophagectomy. If uncovered SEMS ends become embedded, removal of the stent may cause major damage to the esophageal wall. It is therefore recommended to remove embedded partially covered SEMS only after first placing a fully covered SEMS or self-expanding plastic stent inside this stent to necrotize the ingrown tissue at the uncovered stent ends.     

Self-expanding metal stents in benign biliary strictures due to chronic pancreatitis

BACKGROUND AND STUDY AIMS: In selected patients with chronic pancreatitis in whom conventional plastic stenting fails and in whom surgery is contraindicated or declined, insertion of a biliary self-expanding metal stent (SEMS) may be a valuable treatment option. PATIENTS AND METHODS: Between 1994 and 1999, 13 patients with chronic pancreatitis received SEMS for benign biliary strictures (four women and nine men; mean age 56). The indications for SEMS placement were: contraindication to surgery (n = 10), presumed inoperable pancreatic carcinoma (n = 1), concomitant unresectable lung cancer (n = 1), and declined surgery (n = 1). The success of treatment was defined as adequate biliary drainage due to SEMS therapy. RESULTS: The mean follow-up period was 50 months (range 6 days - 86 months). Nine patients (69 %) were successfully treated with SEMS therapy: a patent first SEMS (n = 5); a patent second SEMS inserted through the first SEMS (n = 3); and one patent SEMS after balloon cleaning. SEMS treatment was not successful in four patients (due to stent migration in one case and occlusion in three ). The mean patency period of the SEMS was 60 months (95 % CI, 43 months - 77 months). At 33 months, the probability of adequate biliary drainage with SEMS therapy was 75 %. CONCLUSIONS: SEMS therapy was safe and provided successful and prolonged biliary drainage in a selected group of patients with benign biliary strictures due to chronic pancreatitis in whom surgical intervention was not possible or desirable.     

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.     

EUS-guided biliary drainage with placement of a new partially covered biliary stent for palliation of malignant biliary obstruction: a case series

Endoscopic ultrasonography-guided biliary drainage (EUS-BD) has been developed as an alternative drainage technique in patients with obstructive jaundice where endoscopic retrograde cholangiopancreatography (ERCP) has failed. Between July 2008 and December 2009, 16 patients (9 men; median age 79 years) with biliopancreatic malignancy, who were candidates for alternative techniques of biliary decompression because ERCP had been unsuccessful, underwent EUS-BD with placement of a transmural or transpapillary partially covered nitinol self-expandable metal stent (SEMS). EUS-assisted cholangiography was successful in all patients, with definition of the relevant anatomy, but biliary drainage was successfully performed in only 12 (75?%) of the 16 patients (9 choledochoduodenostomies with SEMS placement and 3 biliary rendezvous procedures with papillary SEMS placement), with regression of the cholestasis. No major complications and no procedure-related deaths occurred. There was one case of pneumoperitoneum which was managed conservatively. The median follow-up was 170 days. During the follow-up, eight patients of the 12 patients in whom biliary draining was successful died; four are currently alive. None of the patients required endoscopic reintervention. This series demonstrated that EUS-BD with a partially covered SEMS has a high rate of clinical success and low complication rates, and could represent an alternative choice for biliary decompression.     

改进型胰胆管支架在全覆膜金属支架治疗良性胆管狭窄中的应用价值*

目的探讨改进型胰管支架在全覆膜自膨式可回收金属支架(FCSERMS)治疗良性胆管狭窄(BBS)中的应用价值。方法回顾性分析2012年1月-2017年12月采取内镜逆行胰胆管造影(ERCP)置入FCSERMS治疗的59例BBS患者的临床资料,比较改进型胰胆管支架(试验组)与单猪尾胰管支架+鼻胆引流管(对照组)在FCSERMS置入及取出术后出现急性胰腺炎(AP)、高淀粉酶血症(HP)和一般淀粉酶升高(GAE)等胰腺损伤情况。结果 59例BBS患者均成功置入FCSERMS及胰管支架。其中,试验组23例,对照组36例。两组术后均无AP发生,HP及GAE的发生率差异均无统计学意义(4.3%vs 5.6%,P=0.516;26.1%vs 22.2%,P=0.508)。术后1周均成功拔除改进型胰胆管支架及鼻胆管,两组均未发生FCSERMS移位及胰腺损伤。FCSERMS平均留置(7.88±1.29)个月(7~12个月),两组无AP、FCSERMS或胰管支架移位发生,试验组HP及GAE的发生率低于对照组(0.0%vs 2.7%,P=0.246;0.0%vs 8.3%,P=0.007)。59例FCSERMS及36例胰管支架均成功取出,未发生出血、肠穿孔和AP等并发症,对照组胰管支架均为蛋白栓堵塞,两组术后GAE的发生率差异无统计学意义(13.0%vs 8.3%,P=0.249)。结论早期取出用于预防FCSERMS治疗BBS术后胰腺炎的胰管支架是安全的,可以避免支架堵塞引起的胰腺损伤。     

Endoscopic hemostasis using covered metallic stent placement for uncontrolled post-endoscopic sphincterotomy bleeding

Severe bleeding following endoscopic biliary sphincterotomy (EBS) can sometimes be difficult to manage, resulting in the need for an invasive intervention. The aim of this study was to retrospectively evaluate the feasibility and efficacy of endoscopic hemostasis using covered self-expandable metallic stents (SEMSs) for severe post- EBS bleeding. Eleven patients with bile duct stones underwent standard EBS using a standard sphincterotome-based technique at 4 endoscopic units of a university-affiliated hospital and a general hospital. Monotherapy or combined therapy were used to achieve hemostasis with either balloon tamponade, hypertonic saline epinephrine injection, or endoclip placement. When active bleeding could not be controlled, covered SEMSs were placed across the major papilla. Emergency endoscopy was performed on the day of admission or the subsequent day (ranging from 6 to 35 h after admission). Bleeding was classified as mild in 6 cases (54.5 %) and moderate in 5 (45.5 %). A covered SEMS 10mm in diameter and 6 cm long was placed across the papilla. After placement, complete hemostasis was achieved. The mean duration of stent placement was 8.2 days (range 5–10 days), and the SEMS was successfully removed in all cases. Although the present study has the limitations of a small sample size and lack of control patients, covered SEMS placement for endoscopic hemostasis may be useful in selected patients with uncontrolled post-EBS bleeding.     

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.     

自膨式金属食管支架的临床应用

目的 :探讨自膨式食管支架 (Self-ExpandingMetalStent,SEMS)治疗吞咽困难患者的临床效果、适应症及并发症。方法 :收集我院安置的食管支架患者 32例之临床相关资料。以 5分法记录支架安置前后吞咽困难程度。并发症出现的时间以 30天为界。结果 :吞困难评分由安置前的 3 43降为安置后的 1 15 (P <0 . 0 5 )。食管 支气管瘘全部痊愈 (4例 )。 6例患者支架安置后发生了早期并发症 ;出血 (2例 )、胸骨后疼痛不适 (4例 )。 1例发生了远期并发症 :支架移位。结论 :自膨式食管支架安置能迅速、有效地改善吞咽困难 ,提高患者生活质量 ,延长生存期限。是否适用于良性食管梗阻尚有争议。严格掌握适应症及新型食管支架的问世 ,有望减少安置术后并发症     

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。     

食管良恶性狭窄和瘘的食管支架治疗：附39例报告

评价食管支架治疗食管良恶性狭窄和瘘的临床疗效,探讨食管支架放置成功的影响因素。材料与方法：对３９例严重吞咽困难患者放置了食管内支架,其中男２９例,女１０例,年龄３４－８３岁,食管恶性狭窄３１例,良性狭窄７例,单纯巨大食管胸腔廉１例。     

Palliation of esophageal carcinoma with a new self-expanding plastic stent

BACKGROUND AND STUDY AIMS: Self-expandable metallic covered stents (SEMS) are widely used for the palliation of esophageal cancer. In the long term, a drawback of these stents is the occurrence of nontumoral occlusion at their proximal or distal parts. New self-expanding plastic stents (SEPS) may combine the advantages of SEMS with those of previously used plastic stents. Our aim was to study prospectively the implantation of such stents in a series of patients with fairly long life expectancy, focusing on safety, feasibility and long-term effectiveness. PATIENTS AND METHODS: Between June 1999 and December 2000, in a prospective cohort study, 33 patients were treated with Polyflex stents for palliation of esophageal stenoses, and were followed up until death. The inclusion criteria demanded the presence of a nonresectable or nonoperable, histologically proven, malignant stricture of the esophagus causing significant dysphagia. RESULTS: Stent insertion was successful in all cases. The mean duration of follow-up of the patients was 149.7 days (range 25 - 469). A complete follow-up until death was documented for all patients (n = 33). During the entire follow-up, no stent occlusion was observed which was caused by either nontumoral or tumoral ingrowth, or by nontumoral overgrowth. Stent occlusions were caused only by tumoral overgrowth, and occurred at a rate of 12.1 % (n = 4). The stent migration rate was 6.0 % (n = 2), and the re-intervention rate overall was 21.1 % (n = 7). CONCLUSIONS: These results show that SEPS are effective for the palliation of dysphagia in patients with esophageal malignancies. The immediate results are similar to those observed with SEMS, and the observed low rate of late obstruction suggests that their long-term efficacy might be superior to that of SEMS. This device warrants evaluation in a controlled prospective trial.     

全覆膜金属可回收支架在治疗食管顽固性良性狭窄中的应用价值

目的探讨全覆膜金属可回收支架治疗食管顽固性良性狭窄的安全性及疗效。方法回顾性分析行全覆膜金属可回收支架治疗的33例食管顽固性良性狭窄患者的临床资料,评价治疗的可行性、安全性及疗效。结果 33例患者共计放置可回收支架41支,其中8例患者行二次可回收支架置入,术后均有不同程度胸痛及异物感;术后并发支架移位11例(共计14支),移位发生率34.1%(14/41);其余22例患者(共计27支支架)均于术后4~8周顺利回收。术中及术后无明显出血、穿孔等并发症发生,无支架相关死亡病例。所有患者定期参加随访(12个月),其中12例成功解除梗阻,临床缓解率为36.4%(12/33)。结论全覆膜金属可回收支架用于治疗食管顽固性良性狭窄是安全可靠的,可使部分患者成功解除梗阻,但支架移位发生率高,有待于临床进一步研究解决。     

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.     

胰管塑料支架和/或鼻胆管引流在内镜逆行胰胆管造影术选择性胆管插管困难时的应用研究

目的探讨胰管塑料支架和/或鼻胆管引流在胆总管结石患者内镜逆行胰胆管造影术(ERCP)选择性胆管插管困难(DSBC)时的应用。方法回顾性分析57例ERCP术中DSBC的胆总管结石患者的临床资料,将患者分为胰管塑料支架组、鼻胆管引流组、胰管塑料支架+鼻胆管引流组,观察其手术成功率、术后并发胰腺炎、高淀粉酶血症或其他并发症的发生率,对比分析3组间的差异。结果接受ERCP的57例患者中,胰管塑料支架组13例患者,手术成功2例(15.4%),高淀粉酶血症1例(7.7%),术后胰腺炎2例(15.4%),发热1例(7.7%),出血1例(7.7%);鼻胆管引流组20例患者,手术成功20例(100.0%),无高淀粉酶血症及术后胰腺炎,无出血及发热等并发症的发生;胰管塑料支架+鼻胆管引流组24例患者1次ERCP手术成功19例(79.2%),2次ERCP成功5例(20.8%),4例出现高淀粉酶血症(16.7%),2例出现出血(8.3%),无发热及术后胰腺炎。3组间比较术后胰腺炎的发生和手术成功率差异有统计学意义。结论 ERCP术中DSBC的患者可通过放置胰管支架和/或鼻胆管引流术提高手术的成功率,减少胰腺炎的发生。     

Use of the Bard Memotherm self-expanding metal stent in the palliation of colonic obstruction

Background: Self-expanding metal stents (SEMS) are a recognized means of palliating large bowel obstruction due to colonic neoplasia. The literature mainly relates to the use of modified esophageal stents (expanded diameter, 18–22 mm) in the colorectum. Stent migration has been a common complication and may be related to expanded stent diameter. This series reports our experience with the Memotherm Colorectal SEMS (expanded diameter, 25–30 mm). Methods: Prospective data were collected from February 1999 to September 2000. Sixteen patients (age range = 61–99 years) were considered for the Memotherm Colorectal SEMS. Stents were inserted radiologically under fluoroscopic control. Outcome was classified as a technical success (stent in correct position and expanded) and a clinical success (colon decompressed, symptoms relieved, and bowels working). Results: Thirteen cases (81%) underwent successful SEMS placement. These were technically and clinically successful. Two cases required insertion of two overlapping stents to traverse long strictures. Three unsuccessful cases were emergency presentations in which a guidewire could not be passed across the lesion. Two of these were due to benign strictures and the third to extrinsic compression by ovarian carcinoma. Conclusion: In our experience, the Memotherm Colorectal SEMS was easy to use, was effective in the palliation of obstructing colorectal carcinoma, and appeared to reduce the risk of stent migration.     

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.     

Transnasal endoscopy for direct visual control of esophageal stent placement without fluoroscopy

Placement of self-expanding metal stents (SEMSs) is a well-established treatment for esophageal stenosis and postoperative anastomotic leaks. Conventional endoscopic procedures for SEMS placement require fluoroscopic guidance, but transnasal endoscopy (TNE) with ultraslim endoscopes may allow precise stent release under direct visual control without the need for fluoroscopy. This prospectively collected data investigated the feasibility and safety of TNE-guided SEMS placement without fluoroscopy. Between March 2009 and February 2011, 20 consecutive patients underwent TNE-guided SEMS placement without fluoroscopy. The technical success rate was 100 % and no fluoroscopy was required during the procedures. Five patients underwent SEMS placement as a bedside procedure in the intensive care unit. The mean intervention time was 13.4 minutes (range 6 - 26) and there were no early complications. In summary, TNE-guided SEMS placement allows precise stent placement without fluoroscopic control and can therefore be performed as a simple bedside procedure.