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.

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 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 A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 296
Author(s):  
Irina Kiseleva ◽  
Irina Isakova-Sivak ◽  
Marina Stukova ◽  
Marianna Erofeeva ◽  
Svetlana Donina ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Phase 1 ◽  
Healthy Adults ◽  
Controlled Study ◽  
Temperature Sensitive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Human Influenza Virus ◽  
Live Attenuated Influenza Vaccine

This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.

scholarly journals Endoscopic side-by-side uncovered self-expandable metal stent placement for malignant hilar biliary obstruction

2019 ◽  
Vol 12 ◽  
pp. 263177451984634 ◽  
Author(s):  
Katsuya Kitamura ◽  
Akira Yamamiya ◽  
Yu Ishii ◽  
Yuta Mitsui ◽  
Hitoshi Yoshida
Keyword(s):  
Adverse Events ◽  
Stent Placement ◽  
Biliary Obstruction ◽  
Arterial Embolization ◽  
Metal Stents ◽  
Success Rates ◽  
Metal Stent ◽  
Hilar Biliary Obstruction ◽  
Malignant Hilar Biliary Obstruction ◽  
Self Expandable Metal Stent

Aim: To investigate outcomes of endoscopic bilateral side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents for unresectable malignant hilar biliary obstruction. Methods: We retrospectively analyzed 23 patients who underwent endoscopic biliary uncovered self-expandable metal stent placement for unresectable malignant hilar biliary obstruction between January 2015 and September 2016 at our institution. We performed endoscopic side-by-side placement across the papilla using 10-mm-diameter longer-model uncovered self-expandable metal stents. Outcomes included the technical and functional success rates, recurrent biliary obstruction rate, time to recurrent biliary obstruction, reintervention rate, and incidence of adverse events other than recurrent biliary obstruction. Results: Of the 23 patients, 10 with malignant hilar biliary obstruction underwent endoscopic side-by-side uncovered self-expandable metal stent placement across the papilla (median age, 83 years; 6 men). The locations of malignant hilar biliary obstruction were Bismuth types II ( n = 3), III ( n = 3), and IV ( n = 4). The median common bile duct diameter was 8 mm. The technical and functional success rates were 100% and 80%, respectively. Seven patients (70%) developed recurrent biliary obstruction because of stent occlusions, including early hemobilia in two patients and late tumor ingrowth in five patients. The median time to recurrent biliary obstruction was 66 (95% confidence interval: 29–483) days. Six patients (60%) required reintervention, and 1 (10%) underwent transcatheter arterial embolization for right hepatic arterial pseudoaneurysm. Early adverse events other than recurrent biliary obstruction occurred in four patients and late adverse event in one patient. Conclusion: Endoscopic side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents was technically feasible for unresectable malignant hilar biliary obstruction; however, it might be better to avoid this method for patients with malignant hilar biliary obstruction because of high recurrent biliary obstruction rate and shorter time to recurrent biliary obstruction.

Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 888-893 ◽  
Author(s):  
H Göbel ◽  
A Heinze ◽  
U Niederberger ◽  
T Witt ◽  
V Zumbroich
Keyword(s):  
Adverse Events ◽  
Randomized Study ◽  
Controlled Study ◽  
Acute Migraine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Significant Difference ◽  
Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

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.

Early removal of biflanged metal stents in the management of pancreatic walled-off necrosis: a prospective study

Endoscopy ◽  
2017 ◽  
Vol 50 (06) ◽  
pp. 597-605 ◽  
Author(s):  
Vinay Dhir ◽  
Douglas Adler ◽  
Ankit Dalal ◽  
Nitin Aherrao ◽  
Rahul Shah ◽  
...  
Keyword(s):  
Adverse Events ◽  
Pancreatic Duct ◽  
Recurrence Rate ◽  
Plastic Stents ◽  
Metal Stents ◽  
Plastic Stent ◽  
Early Removal ◽  
Pancreatic Duct Stenting ◽  
Walled Off Necrosis

Abstract Background and study aims Dedicated stents placed under endoscopic ultrasound (EUS) guidance have shown promise for the management of pancreatic walled-off necrosis (WON). A long duration of stent placement may increase the risk of adverse events. We prospectively evaluated the effects of (i) early removal of biflanged metal stents (BFMSs) and (ii) additional stenting of the pancreatic duct with plastic stents in patients with ductal leaks, on the risk of WON recurrence. Patients and methods Symptomatic patients with pancreatic WON underwent EUS-guided BFMS placement, followed by necrosectomy, when required, from Day 3. A 5 Fr plastic stent was placed in patients with ductal leak. BFMS was removed when the WON cavity had collapsed completely. Patients were followed up at 3-month intervals. Results BFMS placement was successful in all 88 patients. A total of 64 patients (72.7 %) underwent necrosectomy (median 3 sessions). All BFMSs were removed at a median of 3.5 weeks (range 3 – 17 weeks). Ductal disconnection and leak occurred in 53/87 (60.9 %) and 61/87 (70.1 %) patients, respectively. A 5 Fr stent was placed in 56/61 patients (91.8 %) with ductal leak. Overall, 22 patients (25.0 %) had adverse events (17 mild, 1 moderate, 3 severe, 1 fatal). Recurrence was noted in 8/88 (9.1 %) at a median follow-up of 22 months. The recurrence rate was higher in patients with ductal disconnection than in those without (13.2 % vs. 2.9 %; P = 0.08), and was similar in patients with vs. without pancreatic duct stenting (7.1 % vs. 12.9 %; P = 0.44). Seven recurrences (87.5 %) partially regressed on follow-up and did not require therapy; in one case, drainage with a plastic stent was performed. Conclusions Short-term BFMS placement is an effective therapy for pancreatic WON. The majority of recurrences developed in patients with ductal disconnection and did not require therapy. Additional pancreatic duct stents probably do not influence the recurrence rate.

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