A new 12-French plastic stent for unresectable distal malignant biliary obstruction

Endoscopy ◽  
2020 ◽  
Vol 52 (06) ◽  
pp. 474-482
Author(s):  
Pierre H. Deprez ◽  
Tom G. Moreels ◽  
Tarik Aouattah ◽  
Hubert Piessevaux ◽  
Enrique Pérez-Cuadrado-Robles
Keyword(s):  
Adverse Events ◽  
Biliary Obstruction ◽  
Malignant Biliary Obstruction ◽  
Plastic Stents ◽  
Metal Stents ◽  
Technical Success ◽  
Stent Patency ◽  
Historical Cohort ◽  
Plastic Stent ◽  
Distal Malignant Biliary Obstruction

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.

scholarly journals Stent patency in patients with distal malignant biliary obstruction receiving chemo(radio)therapy

2017 ◽  
Vol 05 (11) ◽  
pp. E1035-E1043 ◽  
Author(s):  
Sylke Haal ◽  
Jeanin van Hooft ◽  
Erik Rauws ◽  
Paul Fockens ◽  
Rogier Voermans
Keyword(s):  
Biliary Obstruction ◽  
Malignant Biliary Obstruction ◽  
Plastic Stents ◽  
Secondary Outcome ◽  
Rank Test ◽  
Metal Stents ◽  
Stent Patency ◽  
Log Rank Test ◽  
Radio Therapy ◽  
Distal Malignant Biliary Obstruction

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.

scholarly journals A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Bret T. Petersen ◽  
Michel Kahaleh ◽  
Richard A. Kozarek ◽  
David Loren ◽  
Kapil Gupta ◽  
...  
Keyword(s):  
Adverse Events ◽  
Biliary Obstruction ◽  
Stent Migration ◽  
Covered Stent ◽  
Malignant Biliary Obstruction ◽  
Metal Stents ◽  
Technical Success ◽  
Stent Patency ◽  
Stent Occlusion ◽  
Malignant Bile Duct Obstruction

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.

scholarly journals A fém- és műanyag stentek költséghatékonysága malignus epeúti szűkületek esetében – összehasonlító vizsgálat

2016 ◽  
Vol 157 (7) ◽  
pp. 268-274
Author(s):  
Tímea Daróczi ◽  
Renáta Bor ◽  
Anna Fábián ◽  
Ella Szabó ◽  
Klaudia Farkas ◽  
...  
Keyword(s):  
Life Expectancy ◽  
Complication Rate ◽  
Stent Implantation ◽  
Biliary Obstruction ◽  
Malignant Biliary Obstruction ◽  
Plastic Stents ◽  
Metal Stents ◽  
Cost Of Treatment ◽  
Stent Patency ◽  
Plastic Stent

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.

scholarly journals Efficacy of the New Double-Layer Stent for Unresectable Distal Malignant Biliary Obstruction: A Single-Center Retrospective Study

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Ken Ito ◽  
Yoshinori Igarashi ◽  
Takahiko Mimura ◽  
Yui Kishimoto ◽  
Yoshinori Kikuchi ◽  
...  
Keyword(s):  
Life Expectancy ◽  
Biliary Obstruction ◽  
Malignant Biliary Obstruction ◽  
Plastic Stents ◽  
Metal Stents ◽  
Short Life ◽  
First Choice ◽  
Significant Difference ◽  
Distal Malignant Biliary Obstruction ◽  
Short Life Expectancy

Background and Aims. For distal malignant biliary obstruction in cases with short life expectancy, occlusion of plastic stents (PSs) does not usually occur before death, and the application of such a procedure is considered adequate from the viewpoint of cost-effectiveness. Methods and Setting. A new commercially available DLS with side holes, a conventional DLS, and, uncovered self-expanding metal stents (SEMSs) were retrospectively evaluated in patients with jaundice due to unresectable distal malignant biliary obstruction. Results. A total of 64 patients received endoscopic biliary stenting (23 patients with the new DLS, 24 patients with conventional DLS, and 17 patients with uncovered SEMS) from December 2002 to August 2009. Median patency time was found to be 198 days for the new DLS group and 99 days for the conventional DLS group, revealing a significant difference between devices. There was, however, no significant difference in median patency time between the new DLS and the uncovered SEMS (198 days versus 344 days). Conclusion. The new DLS is efficient and safe and may be considered the first choice for unresectable distal malignant obstruction in cases with short life expectancy.

scholarly journals A randomized trial comparing winged versus conventional plastic stents for malignant bile duct strictures

2017 ◽  
Vol 05 (07) ◽  
pp. E635-E641 ◽  
Author(s):  
Lachlan Ayres ◽  
Danny Cheriyan ◽  
Ryan Scott ◽  
Edward Kim ◽  
Terry Lee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Biliary Obstruction ◽  
Malignant Biliary Obstruction ◽  
Conventional Group ◽  
Plastic Stents ◽  
Stent Insertion ◽  
Endoscopic Retrograde ◽  
Stent Patency ◽  
Plastic Stent ◽  
Blinded Trial

Abstract Background and study aims Stent insertion at endoscopic retrograde cholangiopancreatography (ERCP) is an established therapy for managing malignant biliary obstruction. Conventional plastic stents with a tubular design are most commonly used despite limited patency. Plastic stents with a winged design may theoretically increase the duration of stent patency. The aim of this study was to compare stent patency of the winged versus conventional plastic stents in patients with malignant biliary obstruction. Patients and methods A prospective, randomized subject-blinded trial was conducted. Patients with malignant biliary obstruction were randomized (1:1) to either a 10 French winged stent or 7 or 10 French conventional plastic stent. Strictures greater than 1 cm distal to the hilum were included. Patients were followed clinically to determine the frequency of stent failure until surgery, death or study closure. Results Fifty-eight patients were enrolled. Following 9 exclusions, 49 patients were randomized to a winged (n = 23) or conventional stent (n = 26). Median time to stent failure was 89 (95 % CI 26-NA) vs 143 (95 % CI 33 – 266) days (P = 0.963) for the winged and conventional group, respectively. Stent failure for the winged group occurred in 11 (48 %) compared to 14 (54 %) in the conventional group. Median survival was 123 (95 % CI 81 – 189) vs 342 days (95 % CI 123 – 704) (p = 0.084) in the winged and conventional group respectively. There were no procedure related adverse events. Conclusions Improvement in stent patency was not seen with the winged stent when compared to the conventional plastic stent. Clinical trials number NCT01514214.

scholarly journals Efficacy of an internal anchoring plastic stent to prevent migration of a fully covered metal stent in malignant distal biliary strictures: a randomized controlled study

Endoscopy ◽  
2020 ◽  
Author(s):  
Woo Hyun Paik ◽  
Sang Myung Woo ◽  
Jung Won Chun ◽  
Byeong Jun Song ◽  
Woo Jin Lee ◽  
...  
Keyword(s):  
Adverse Events ◽  
Biliary Obstruction ◽  
Survival Rates ◽  
Stent Migration ◽  
Controlled Study ◽  
Metal Stents ◽  
Stent Patency ◽  
Serious Adverse Events ◽  
Plastic Stent ◽  
Superiority Trial

Abstract Background Two types of self-expandable metal stents (SEMS) are available for malignant distal biliary obstruction: fully covered SEMS (FCSEMS) and uncovered SEMS. FCSEMS can prevent stent ingrowth, but a major concern is spontaneous migration. This study aimed to determine whether the additional insertion of a double-pigtail plastic stent to anchor the FCSEMS can prevent migration. Methods 68 patients with unresectable, malignant, distal, biliary obstruction were included in this multicenter, randomized, superiority trial. The patients were randomly assigned to receive either the FCSEMS plus an anchoring plastic stent (n = 33) or an FCSEMS alone (n = 35). After placement of the FCSEMS, the anchoring stent was inserted inside the FCSEMS. The primary outcome was the rate of stent migration during the 6-month follow-up. The secondary outcomes were stent-related adverse events, stent patency, and survival rates. Results The baseline characteristics were similar between the two groups. The rate of stent migration at 6 months was significantly lower in patients with the FCSEMS plus anchoring stent (15 % vs. 40 %; P = 0.02). The mean stent patency was significantly longer in the FCSEMS plus anchoring group (237 days [95 % confidence interval [CI] 199 to 275] vs. 173 days [95 %CI 130 to 217]; P = 0.048). There were no significant differences in stent-related adverse events and overall survival rates at 6 months between the two groups. Conclusions Our data suggest that the additional double-pigtail plastic stent anchored the FCSEMS to prevent migration and prolonged patency without any serious adverse events.

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