ePTFE/FEP stents for malignant biliary obstruction

2020 ◽  
pp. bmjspcare-2019-001961
Author(s):  
Andrew Hui ◽  
Miltiadis Krokidis

BackgroundBiliary obstruction due to malignant disease causes debilitating symptoms and palliation of the disease involves placement of biliary stents. Covered self-expanding metal biliary stents may provide a longer patency and a lower risk of complications and dysfunction compared to uncovered stents, making them better for patients’ quality of life and cost effectiveness. This study aims to evaluate the indications and outcomes for a group of cases where expanded polytetrafluoroethylene/fluorinated ethylene propylene (ePTFE/FEP) covered metal stents were used to palliate malignant biliary obstruction.MethodsAll cases of ePTFE/FEP-covered Viabil stent implantation in a 4-year period in a single hospital were identified and details of indications and outcomes for stent placement were recorded. Kaplan-Meier estimator analysis was used to create plots for stent patency and survival time.ResultsThe median stent patency was 173 days (standard error of the mean, SE = 54) and the median survival time was 247 days (SE = 88). No complications of stent implantation were recorded and in seven cases no dysfunction was noted. In one case, tumour ingrowth was observed, and in one other case the stent was no longer found in situ on subsequent imaging.ConclusionThe use of the ePTFE/FEP-covered Viabil stent in the palliation of malignant obstruction where indicated is promising, providing a low rate of stent dysfunction and complications. More data need to be collected to conclusively ascertain whether covered stents have a longer patency and lower complication rate compared to uncovered stents.

2016 ◽  
Vol 157 (7) ◽  
pp. 268-274
Author(s):  
Tímea Daróczi ◽  
Renáta Bor ◽  
Anna Fábián ◽  
Ella Szabó ◽  
Klaudia Farkas ◽  
...  

Introduction: Self-expandable metal and plastic stents can be applied in the palliative endoscopic treatment of patients with unresectable malignant biliary obstruction. The use of metal stentsis recommended if the patient’s life expectancy is more than four months. Aim: To compare the therapeutic efficacy and cost-effectiveness of metal and plastic stents in the treatment of malignant biliary obstruction. Method: The authorsretrospectively enrolledpatients who received metal (37 patients) or plastic stent (37 patients). The complication rate, stent patency and cumulative cost of treatment were assessed in the two groups. Results: The complication rate of metal stents was lower (37.84% vs. 56.76%), but the stent patency was higher compared with plastic stents (19.11 vs. 8.29 weeks; p = 0.0041). In the plastic stent group the frequency of hospitalization of patients in context with stent complications (1.18 vs. 2.32; p = 0.05) and the necessity of reintervention for stent dysfunction (17 vs. 27; p = 0.033) were substantially higher. In this group multiple stent implantation raised the stent patency from 7.68 to 10.75 weeks. There was no difference in the total cost of treatment of malignant biliary obstruction between the two groups (p = 0.848). Conclusions: Considering the cost of treatment and the burden of patients the authors recommend self-expandable metal sten timplantation if the life expectancy of patients is more than two months. In short survival cases multiple plastic stent implantation is recommended. Orv. Hetil., 2016, 157(7), 268–274.


2017 ◽  
Vol 34 (04) ◽  
pp. 369-375 ◽  
Author(s):  
Tomas DaVee ◽  
Jeffrey Lee

AbstractPainless jaundice is a harbinger of malignant biliary obstruction, with the majority of cases due to pancreatic adenocarcinoma. Despite advances in treatment, including improved surgical techniques and neoadjuvant (preoperative) chemotherapy, long-term survival from pancreatic cancer is rare. This lack of significant improvement in outcomes is believed to be due to multiple reasons, including the advanced stage at diagnosis and lack of an adequate biomarker for screening and early detection, prior to the onset of jaundice or epigastric pain. Close attention is required to select appropriate patients for preoperative biliary decompression, and to prevent morbid complications from biliary drainage procedures, such as pancreatitis and cholangitis. Use of small caliber plastic biliary stents during endoscopic retrograde cholangiopancreatography should be minimized, as metal stents have increased area for improved bile flow and a reduced risk of adverse events during neoadjuvant therapy. Efforts are underway by translational scientists, radiologists, oncologists, surgeons, and gastroenterologists to augment lifespan for our patients and to more readily treat this deadly disease. In this review, the authors discuss the rationale and techniques of endoscopic biliary intervention, mainly focusing on malignant biliary obstruction by pancreatic cancer.


Endoscopy ◽  
2020 ◽  
Vol 52 (06) ◽  
pp. 474-482
Author(s):  
Pierre H. Deprez ◽  
Tom G. Moreels ◽  
Tarik Aouattah ◽  
Hubert Piessevaux ◽  
Enrique Pérez-Cuadrado-Robles

Background Self-expanding metal stents (SEMSs) are recommended in unresectable distal malignant biliary obstruction. However, problems with dysfunction and migration of these stents are not negligible. We aimed to investigate the effectiveness and safety of a new 12-Fr plastic stent. Methods In an observational, prospective study, all consecutive patients who underwent biliary stenting with the 12-Fr stent were considered (index group). Referent groups were a historical cohort, matched by sex, etiology, and metastatic status, including patients with 10-Fr plastic stents and with fully covered and uncovered SEMSs (FCSEMSs and UCSEMSs). Outcomes were stent patency, recurrent biliary obstruction (RBO), technical success, 30-day mortality and adverse events. A post-procedure examination of removed stents was done. Results 72 patients (median age 66, range 32 – 94 years, 50 % men) were included (24 index, 48 referents). There were no differences in median stent patency time (P = 0.684). RBO was significantly lower with the 12-Fr compared with the 10-Fr profile stent (50 % vs. 81.3 %, P = 0.04), but no difference was found compared with the FCSEMSs (50 % vs. 43.8 %, P = 0.698). Technical success was 100 %, with no differences in 30-day mortality P = 0.105). The adverse events rate was 4.2 % for both groups (index n = 1, referents n = 2). Of 11 removed 12-Fr plastic stents suspected to be dysfunctional, 7 (64 %) were still patent. Conclusions This new 12-Fr plastic stent could be an effective and cheaper alternative to SEMSs in distal malignant biliary obstruction.


2017 ◽  
Vol 05 (11) ◽  
pp. E1035-E1043 ◽  
Author(s):  
Sylke Haal ◽  
Jeanin van Hooft ◽  
Erik Rauws ◽  
Paul Fockens ◽  
Rogier Voermans

Abstract Background and study aims Recent literature suggests that chemo(radio)therapy might reduce the patency of plastic stents in patients with malignant biliary obstruction. Whether this might also be valid for other types of stents is unknown. The aim of this study was to determine the influence of chemo(radio)therapy on the patency of fully-covered self-expandable metal stents (FCSEMSs) and plastic stents. Patients and methods We retrospectively reviewed the electronic medical records of patients with distal malignant biliary obstruction who underwent biliary stent placement between April 2001 and July 2015. Primary outcome was duration of stent patency. Secondary outcome was stent patency at 3 and 6 months. We used Kaplan–Meier survival analyses to compare stent patency rates between patients who received chemo(radio)therapy and patients who did not. Results A total of 291 biliary stents (151 metal and 140 plastic) were identified. The median cumulative stent patency of FCSEMSs did not differ between patients receiving chemo(radio)therapy (n = 51) and those (n = 100) who did not (P = 0.70, log-rank test). The estimated cumulative stent patency of plastic stents was also comparable in 99 patients without and 41 patients with chemo(radio)therapy (P = 0.73, log-rank test). At 3 and 6 months, FCSEMS patency rates were 87 % and 83 % in patients without chemo(radio)therapy and 96 % and 83 % in patients with therapy, respectively. Plastic patency rates were 69 % and 55 % in patients without and 85 % and 39 % in patients with therapy, respectively. After 1 year, 78 % of the FCSEMSs were still patent in patients without chemo(radio)therapy and 69 % of the FCSEMSs were still patent in patients with therapy. Conclusion Our data indicate that chemo(radio)therapy does not reduce the patency of biliary fully-covered metal and plastic stents.


2020 ◽  
Vol 04 (03) ◽  
pp. 323-333
Author(s):  
Derek Taeyoung Kim ◽  
Uzma Rahman ◽  
Robert W. Tenney ◽  
Oleandro A. Cercio Roa ◽  
Pawan Rastogi ◽  
...  

AbstractTreatment of malignant biliary obstruction (MBO) requires the coordination of multiple specialties, including oncologists, surgeons, gastroenterologists, and interventional radiologists. If the tumor is resectable, surgical candidates can usually proceed to surgery without preoperative biliary drainage. For patients who undergo biliary drainage, endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC) combined with biliary stenting are techniques with comparable technical success and mortality, each with distinct advantages and risks. Advances in endoscopic ultrasound allow drainage in patients with challenging anatomy. There are a multitude of devices used for biliary decompression. Self-expanding metal stents (SEMS), with longer patency rates, are in most instances preferred over plastic stents for MBO, especially in patients with life expectancy more than 3 to 4 months. Advantages of covered SEMS versus uncovered SEMS remain controversial as covered stents can prevent tumor ingrowth but at the expense of potential increase in stent migrations. Extra-anatomic biliary drainage using lumen-apposing metal stents is an emerging technique which shows promise when conventional ERCP fails. It is imperative to understand these techniques when tailoring a treatment strategy. The goal of this article is to discuss a multidisciplinary approach for MBO to promote comprehensive care using case examples to highlight essential principles.


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Bret T. Petersen ◽  
Michel Kahaleh ◽  
Richard A. Kozarek ◽  
David Loren ◽  
Kapil Gupta ◽  
...  

Background and Study Aims. Endoscopic placement of self-expanding metal stents (SEMSs) is indicated for palliation of inoperable malignant biliary obstruction. A fully covered biliary SEMS (WallFlex Biliary RX Boston Scientific, Natick, USA) was assessed for palliation of extrahepatic malignant biliary obstruction.Patients and Methods. 58 patients were included in this prospective, multicenter series conducted under an FDA-approved IDE. Main outcome measurements included (1) absence of stent occlusion within six months or until death, whichever occurred first and (2) technical success, need for reintervention, bilirubin levels, stent patency, time to stent occlusion, and adverse events.Results. Technical success was achieved in 98% (57/58), with demonstrated acute removability in two patients. Adequate clinical palliation until completion of followup was achievedin 98% (54/55) ofevaluablepatients, with 1 reintervention due to stent obstruction after 142 days. Mean total bilirubin decreased from 8.9 mg/dL to 1.2 mg/dL at 1 month. Device-related adverse events were limited and included 2 cases of cholecystitis. One stent migrated following radiation therapy.Conclusions. The WallFlex Biliary fully covered stent yielded technically successful placement with uncomplicated acute removal where required, appropriate reduction in bilirubin levels, and low rates of stent migration and occlusion. This SEMS allows successful palliation of malignant extrahepatic biliary obstruction.


2020 ◽  
Vol 61 (12) ◽  
pp. 1591-1599
Author(s):  
Aboelyazid Elkilany ◽  
Mohamed Alwarraky ◽  
Dominik Geisel ◽  
Mohamed A Maaly ◽  
Timm Denecke

Background Considering the limitations in both uncovered self-expandable metallic stents (USEMS) and covered self-expandable metallic stents (CSEMS), it is difficult to make a general recommendation for their application in percutaneous decompression of malignant biliary obstruction (MBO). Purpose To compare percutaneous transhepatic CSEMSs versus USEMSs for the palliative treatment of MBO in terms of technical success, clinical success, stent patency, patient survival, complications, and stent dysfunction. Material and Methods This prospective randomized study included 66 patients with unresectable MBO. CSEMSs were inserted in 31 patients (26 men, 5 women; mean age = 63.8 ± 7.96 years) and USEMSs were inserted in 35 patients (26 men, 9 women; mean age = 62.3 ± 11.7 years). Results Mean primary stent patency duration was 138 ± 92.7 days in CSEMSs versus 150 ± 77.9 days in USEMSs ( P = 0.578). Tumor overgrowth occurred exclusively in one patient with CSEMS ( P = 0.470) and tumor ingrowth exclusively in two patients with USEMS ( P = 0.494). Stent migration occurred in two patients with CSEMSs versus one patient with USEMSs ( P = 0.579). Hemobilia occurred in five patients with CSEMSs versus three patients with USEMSs while bile leakage occurred in one patient in each group despite the larger introducer sheath caliber with CSEMSs (9 F vs. 6–7 F). There was no significant difference regarding patient survival ( P = 0.969). Conclusion In our cohort of patients with rather poor life expectancy, there was no significant difference between covered and uncovered stents for the palliative treatment of MBO. However, considering the higher cost of CSEMs and the larger introducer diameter necessary for their placement, USEMSs can be preferred.


2020 ◽  
Vol 22 (7) ◽  
Author(s):  
Lian-Biao Li ◽  
Wen-Yan Qin ◽  
Wen-Ping Peng ◽  
Jin-Zhen Li ◽  
Ming-Ming Zhang ◽  
...  

Context: Self-expandable metal stents (SEMSs) are commonly used in the treatment of malignant biliary obstruction. We performed a meta-analysis to compare the efficacy of covered self-expandable metallic stents (CSEMSs) and uncovered self-expandable metallic stents (UCSEMSs) for patients with malignant distal biliary obstruction. Methods: A comprehensive search was conducted using PubMed, Embase, Cochrane, and CNKI databases from 2010 to 2019. All randomized controlled trials, which compared the use of the CSEMSs and UCSEMSs for the treatment of malignant distal biliary obstruction were included in this study. Results: This meta-analysis included 1,539 patients enrolled in 13 trials. There was no difference between the two groups in terms of patients’ survival (hazard ratio (HR) 0.96, 95% confidence interval (CI): 0.87 - 1.07; I2 = 32.6%), stent patency (HR 0.92, 95% CI: 0.69 - 1.22; I2 = 56.3%), and the overall complication rate (relative risks (RR) 1.35, 95% CI: 0.82 - 2.23; I2 = 0%). In particular, the CSEMSs group presented a lower rate of tumor ingrowth (RR 0.30, 95% CI: 0.15 - 0.57; I2 = 58.5%) than the UCSEMSs group. However, the CSEMSs group exhibited a higher rate of tumor overgrowth (RR 1.63, 95% CI: 1.00 - 2.66; I2 = 0%), sludge formation (RR 2.28, 95% CI: 1.36 - 3.82; I2 = 0%), and migration (RR 5.14, 95% CI: 1.90 - 13.88; I2 = 0%). Conclusions: Our meta-analysis indicated that there was no significant difference between the two stents, and each one had its advantages and disadvantages.


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