scholarly journals Safety, efficacy, and removability of a fully covered multi-hole metal stent in a swine model of hilar biliary stricture: a feasibility study

2019 ◽  
Vol 07 (04) ◽  
pp. E498-E503 ◽  
Author(s):  
Jin-Seok Park ◽  
Seok Jeong ◽  
Makoto Kobayashi ◽  
Don Lee
Keyword(s):  
Success Rate ◽  
Biliary Stricture ◽  
Stent Migration ◽  
Metal Stents ◽  
Stent Insertion ◽  
Swine Model ◽  
Type I ◽  
Stent Patency ◽  
Technical Success Rate ◽  
Hilar Biliary Stricture

Abstract Background and study aims Use of fully covered self-expandable metal stents (FCSEMS) for biliary drainage of malignant hilar biliary strictures is limited because of risk of cholangitis due to side branch obstruction. The aim of this study was to evaluate the safety and efficacy of unilateral placement of a multi-hole FCSEMS (FCSEMS-MH), which had a 2.5-mm hole in the center of the membrane on each cavity, in a swine model of hilar biliary stricture. Materials and methods Six female mini pigs were included in this prospective study. The hilar biliary stricture model was prepared using an endobiliary radiofrequency ablation. FCSEMS-MHs were endoscopically inserted into the peri-hilar bile duct of all the animals. Outcomes were assessed in terms of adverse events (AEs) including cholangitis, stent patency, stent migration, and endoscopic stent removability for 1 month after stenting. Results In terms of hilar biliary stricture types, two animals were of Bismuth type I and four were of type II. Technical success rate for endoscopic metal stenting was 100 % (6/6), and the functional success rate, which was evaluated 7 days after stent insertion, was also 100 % (5/5). The immediate overall AE rate was 0 %. There was no procedure-related mortality and stent migration did not occur in any animal during the 4-week stent indwelling period. Stents were removed from all six animals at 4 weeks post-stenting. Conclusion Unilateral placement of FCSEMS-MH might be safe and effect for swine hilar biliary stricture models. However, long-term follow-up and comparative studies are needed to verify the usefulness of this stent.

Clinical outcomes in hybrid repair procedures for pathologies involving the aortic arch

Vascular ◽  
2014 ◽  
Vol 23 (1) ◽  
pp. 9-16 ◽  
Author(s):  
Sebastian Zerwes ◽  
Giesbert Leissner ◽  
Yvonne Gosslau ◽  
Rudolf Jakob ◽  
Hans-Kees Bruijnen ◽  
...  
Keyword(s):  
Success Rate ◽  
Aortic Arch ◽  
Circulatory Arrest ◽  
Aortic Disease ◽  
Aortic Aneurysms ◽  
Type I ◽  
Technical Success ◽  
Aortic Diseases ◽  
Promising Alternative ◽  
Technical Success Rate

Objective Fifty patients with complex aortic disease, who received hybrid treatment of the aortic arch with supra-aortic debranching and endovascular stent-graft repair, were evaluated in regard to events of primary (survival and technical success) and secondary (procedure-related complications) interest. Methods The single-center study was conducted over an eight-year period from December 2004 to December 2012. Treated medical conditions included 23 aortic aneurysms (46%), 21 aortic dissections (42%), and six penetrating aortic ulcers (12%). Procedures were divided into groups of elective, urgent, and emergent. Results Twenty-eight (56%) patients were operated electively, 15 (30%) urgently, and seven (14%) emergently. Sternotomy, cardiopulmonary bypass, and deep hypothermic circulatory arrest were required in 12 (24%) patients. The primary technical success rate was 86% and raised to 92% ( n = 46) of secondary technical success rate after therapy of three type I endoleaks. The 30-day mortality added up to 16.0%, and the mean time of survival was 49.3 months. In a total of eight (16%) patients, an endoleak occurred (five endoleaks type I, three endoleaks type II), while nine (18%) of patients suffered a perioperative stroke. Conclusions In severely ill patients with complex aortic diseases, hybrid therapy may offer a promising alternative to conventional open repair.

scholarly journals Endoscopic biliary self-expandable metallic stent in malignant biliary obstruction with or without sphincterotomy: systematic review and meta-analysis

2019 ◽  
Vol 07 (01) ◽  
pp. E26-E35 ◽  
Author(s):  
Benedetto Mangiavillano ◽  
Amedeo Montale ◽  
Leonardo Frazzoni ◽  
Mario Bianchetti ◽  
Amrita Sethi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Success Rate ◽  
Meta Analysis ◽  
Stent Insertion ◽  
Metallic Stent ◽  
Success Rates ◽  
Technical Success ◽  
Technical Success Rate ◽  
Expandable Metallic Stent ◽  
Increased Risk

Abstract Background and aim To assess the rate of adverse events and the technical success rate of biliary stenting with or without EBS.  Methods A literature search up to February 2017 was performed. Studies assessing adverse events (AEs) and technical success rates of stenting with or without EBS were considered. Results Seven studies (870 patients; 12 treatment arms) were included. Early AEs, i. e. those occurring within 30 days, were significantly lower in no-EBS vs. EBS-group (11 % vs. 20.1 %; OR: 0.36, 95 %CI: 0.13 – 1.00). Rates of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis were not significantly different in the two groups (no-EBS vs. EBS: 6.1 % vs 5 %; OR: 1.33, 95 %CI: 0.68 – 2.59). The rate of bleeding was significantly lower in patients without EBS (no-EBS vs EBS: 0 % vs 5 %; OR: 0.12, 95 % CI: 0.03 – 0.45). Rates of cholangitis were significantly lower in patients without EBS (no-EBS vs. EBS: 3.3 % vs. 7.4 %; OR: 0.38, 95 %CI: 0.17 – 0.83). Both late AEs and mortality rates did not significantly differ between no-EBS and EBS patients (19.9 % vs. 18.9 %; OR: 0.93, 95 %CI: 0.56 – 1.53, and 2.5 % vs. 2.9 %; OR: 1.18, 95 %CI: 0.22 – 6.29, respectively). The technical success rate for stent insertion also did not differ (98 % vs. 97.6 %; OR: 1.05, 95 %CI: 0.42 – 2.63). Conclusion EBS seems to be associated, in the first 30 days after the procedure, with an increased risk of cholangitis and bleeding. No difference was observed in the rate of post-ERCP pancreatitis.

Self-Expanding Metal Stents for the Treatment of Post-Surgical Esophageal Leaks: A Tertiary Referral Center Experience

2018 ◽  
Vol 36 (4) ◽  
pp. 309-316 ◽  
Author(s):  
Andrea Anderloni ◽  
Chiara Genco ◽  
Marco Massidda ◽  
Milena Di Leo ◽  
Uberto Romario Fumagalli ◽  
...  
Keyword(s):  
Success Rate ◽  
Stent Placement ◽  
Secondary Outcome ◽  
Metal Stents ◽  
Stent Insertion ◽  
Therapeutic Success ◽  
Tertiary Referral Center ◽  
Stent Type ◽  
Self Expanding Metal Stents ◽  
Secondary Closure

Background/Aims: The study aimed to evaluate the effectiveness and safety of self-expanding metal stents (SEMS) in the management of post-surgical esophageal leaks. Methods: Retrospective data of consecutive patients with a post-surgical esophageal leak treated by means of a metal stent between January 2008 and December 2014 at the Humanitas Research Hospital (Milan, Italy) were extracted from a prospectively maintained register of SEMS used for benign indications, such as post-surgical benign esophageal strictures and/or leaks. The primary outcome of the study was to assess the rate of successful leak closure and to identify the variables associated with its achievement. As a secondary outcome, we evaluated the overall safety of SEMS placement and the efficacy and safety for different types of SEMS in this specific setting of patients. Leak resolution was documented with endoscopic and/or imaging studies. In the case of leak persistence, further attempts of esophageal stenting were carried out at the discretion of both endoscopists and surgeons. Results: A total of 49 patients were included in the study (men 41 of 49, 83.7%, mean age 62.4 ± 11.9). One patient was excluded from analysis, because of death 1 day after stent insertion due to worsening of pre-existing mediastinitis. A total number of 82 stents were placed (mean number of stents per patient: 1.7) in 49 patients: 35 patients (71.4%) received a partially covered SEMS (PCSEMS) as the first stent positioned, while the remaining 14 (28.6%) received a fully covered SEMS (FCSEMS); but 1 patient (2%) died following stent insertion; therefore, data regarding therapeutic success were available for 48 patients. Stents were left in place for a mean period of 21.9 ± 15.2 days. Leak closure after the first stent placement was achieved in 22 of 48 (45.8%) patients. Of the 26 patients with failure of index stent placement, 18 patients underwent further stenting attempts (69.2%), and secondary closure of leak was achieved in 7 (38.9%) of these 18 patients. Thus, the overall success rate was 60.5% (29 of 48). On the basis of stent type, the success rate was 57.1% (8 of 14) for FCSEMS and 64.7% (22 of 34) for PCSEMS. Logistic regression analysis did not find any significant association between successful leak closure and analyzed variables. Overall mortality was 13.0%. Complication rate was 38.8% (19 of 49 patients). Conclusion: The use of SEMS is an effective and safe option for post-surgical esophageal leaks, with no evidence of any significant influence of stent type on outcome.

scholarly journals Clinical evaluation of physician-controlled guidewire manipulation during endoscopic ultrasound-guided hepaticogastrostomy (with video)

2021 ◽  
Vol 09 (03) ◽  
pp. E395-E400
Author(s):  
Kyohei Nishiguchi ◽  
Takeshi Ogura ◽  
Nobu Nishioka ◽  
Saori Ueno ◽  
Atsushi Okuda ◽  
...  
Keyword(s):  
Bile Duct ◽  
Success Rate ◽  
Endoscopic Ultrasound ◽  
Intrahepatic Bile Duct ◽  
Plastic Stents ◽  
Metal Stents ◽  
Success Rates ◽  
Technical Success ◽  
Technical Success Rate ◽  
Tract Dilation

Abstract Background and study aims Endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS) may be most complex because of the EUS-guided biliary drainage procedure and variations in the course of the intrahepatic bile duct compared with the common bile duct (CBD). Appropriate guidewire insertion is essential. Physician-controlled guidewire manipulation (PCGW) might improve technical success rates of bile duct cannulation. The present study aimed to determine the technical feasibility and safety of PCGW during EUS-HGS. Patients and methods A total of 122 consecutive patients who were scheduled to undergo EUS-HGS between October 2017 and April 2019 were prospectively registered. The primary endpoint was the technical success rate of guidewire insertion into the CBD or hepatic hilum. Guidewire insertion was considered to have failed if the HGS assistant failed to achieve manipulation. Results The intrahepatic bile duct was successfully punctured in 120 of 122 patients. During guidewire insertion by the HGS assistant, guidewire fracture was observed in one patient. The guidewire was successfully inserted into the biliary tract and manipulated by the HGS assistant in 96 patients. PCGW was thus attempted for the remaining 23 patients. The guidewire was inserted by PCGW in all 23 patients, improving the technical success rate for guidewire insertion from 80 % to 100 %. After tract dilation, we deployed covered metal stents and plastic stents in 117 and two patients, respectively. The overall technical success rate for EUS-HGS was 97.5 % (119/122). Adverse events comprising bile peritonitis or leakage developed in five patients. Conclusion PCGW might contribute to improving the success rate of EUS-HGS.

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 Outcomes of EUS-guided choledochoduodenostomy as primary drainage for distal biliary obstruction with covered self-expandable metallic stents

2020 ◽  
Vol 08 (07) ◽  
pp. E861-E868
Author(s):  
Naosuke Kuraoka ◽  
Kazuo Hara ◽  
Nozomi Okuno ◽  
Takamichi Kuwahara ◽  
Nobumasa Mizuno ◽  
...  
Keyword(s):  
Success Rate ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Cancer Center ◽  
Biliary Duct ◽  
Metallic Stent ◽  
Success Rates ◽  
Stent Patency ◽  
Technical Success Rate ◽  
Drainage Technique

Abstract Background and study aims Endoscopic ultrasonography-guided choledochoduodenostomy (EUS-CDS) is an alternative therapy for percutaneous transhepatic biliary drainage. Outcomes of EUS-CDS for distal biliary tract obstruction with a covered self-expandable metallic stent (SEMS) as a primary drainage technique are unclear because there are few relevant reports. This study aimed to determine outcomes in patients undergoing EUS-CDS using SEMS as the primary drainage technique for malignant distal biliary duct obstruction. Patients and methods This retrospective study was conducted at Aichi Cancer Center Hospital, from January 2010 to July 2018, using data from our database. Results EUS-CDS was performed as a primary drainage technique for 92 patients. The technical success rate was 92.8 %, and the clinical success rate was 91.6 %. The overall incidence of adverse events was 15.7 %. The median stent patency time for the EUS-CDS was 396 days. Nineteen patients required re-intervention because of cholangitis or jaundice. Conclusion EUS-CDS as a primary drainage technique using SEMS has high technical and clinical success rates. It should be considered an effective drainage method with respect to long-term stent patency, low re-intervention rates, and absence of severe complications.

scholarly journals Evaluation of the Feasibility and Effectiveness of Placement of Fully Covered Self-Expandable Metallic Stents via Various Insertion Routes for Benign Biliary Strictures

2021 ◽  
Vol 10 (11) ◽  
pp. 2397
Author(s):  
Ko Tomishima ◽  
Shigeto Ishii ◽  
Toshio Fujisawa ◽  
Muneo Ikemura ◽  
Mako Ushio ◽  
...  
Keyword(s):  
Success Rate ◽  
Stent Migration ◽  
Plastic Stents ◽  
Stent Fracture ◽  
Metallic Stent ◽  
Technical Success ◽  
Technical Success Rate ◽  
Expandable Metallic Stent ◽  
Benign Biliary Strictures

Background and aims: The goals of the management of benign biliary stricture (BBS) are to relieve symptoms and resolve short-/long-term stricture. We performed fully covered self-expandable metallic stent (hereafter, FCSEMS) placement for BBS using various methods and investigated the treatment outcomes and adverse events (AEs). Methods: We retrospectively studied patients who underwent FCSEMS placement for refractory BBS through various approaches between January 2017 and February 2020. FCSEMS were placed for 6 months, and an additional FCSEMS was placed if the stricture had not improved. Technical success rate, stricture resolution rate, and AE were measured. Results: A total of 26 patients with BBSs that were difficult to manage with plastic stents were included. The mean overall follow-up period was 43.3 ± 30.7 months. The cause of stricture was postoperative (46%), inflammatory (31%), and chronic pancreatitis (23%). There were four insertion methods: endoscopic with duodenoscopy, with enteroscopy, EUS-guided transmural, and percutaneous transhepatic. The technical success rate was 100%, without any AE. Stricture resolution was obtained in 19 (83%) of 23 cases, except for three cases of death due to other causes. Stent migration and cholangitis occurred in 23% and 6.3%, respectively. Stent fracture occurred in two cases in which FCSEMSs were placed for more than 6 months (7.2 and 10.3 months). Conclusion: FCSEMS placement for refractory BBS via various insertion routes was feasible and effective. FCSEMSs should be exchanged every 6 months until stricture resolution because of stent durability. Further prospective study for confirmation is required, particularly regarding EUS-guided FCSEMS placement.

Preliminary Dual-Center Experience with the Bolton Treovance Endograft

2017 ◽  
Vol 51 (8) ◽  
pp. 533-537 ◽  
Author(s):  
Arron Thind ◽  
Dhruv Sarma ◽  
Abdel Kader Allouni ◽  
Feras Abdallah ◽  
David Murray ◽  
...  
Keyword(s):  
Aortic Aneurysm ◽  
Success Rate ◽  
Stent Graft ◽  
Type I ◽  
Complication Rates ◽  
Technical Success ◽  
Technical Success Rate ◽  
Average Maximum ◽  
Aneurysm Repair

Purpose: To present the performance and safety of the Treovance stent graft for endovascular aortic aneurysm repair in a “real-world” patient cohort. Methods: Patients from 2 centers, deemed unfit for open repair, were electively treated with the Treovance endograft. Clinical preoperative, operative, and up to 1-year postoperative follow-up data of patients were retrospectively analyzed. Results: This study included 46 patients with abdominal aortic aneurysm (44 male), mean age of 78 years ± 8 standard deviation (SD; range: 58-93 years). All met the manufacturer’s recommended anatomical requirements: average maximum sac diameter 63 mm ± 10 SD (range: 52-86 mm), proximal neck length 29 mm ± 12 SD (range: 11-60 mm), and neck angulation 30° ± 21 SD (range: 0°-70°). Fourteen had moderate to severe iliac tortuosity. A primary technical success rate of 80% was achieved (100% assisted primary technical success rate): 7 patients required adjunctive procedures intraoperatively and 2 successful treatments for type I endoleaks, which occurred within 24 hours postoperatively. There was 100% survival at 1-year follow-up; however, 4 (8.7%) patients required reintervention: 1 for a type I endoleak, 2 for limb stenosis, and 1 for a type II endoleak with an enlarging sac. No other device-related complications were identified. Reintervention and complication rates in hostile versus nonhostile anatomies were not statistically significant ( P = .28 and P = .42, respectively). Conclusion: The Treovance stent graft has a comparable safety profile to other next-generation stent grafts during the first year after endovascular aneurysm repair, which provides a rationale for further interrogation of its outcomes through clinical trials.

scholarly journals Current Endoscopic Management of Malignant Biliary Stricture

Medicina ◽  
2020 ◽  
Vol 56 (3) ◽  
pp. 114
Author(s):  
Chi-Chih Wang ◽  
Tzu-Wei Yang ◽  
Wen-Wei Sung ◽  
Ming-Chang Tsai
Keyword(s):  
Biliary Drainage ◽  
Biliary Obstruction ◽  
Biliary Stricture ◽  
Plastic Stents ◽  
Endoscopic Management ◽  
Metal Stents ◽  
Endoscopic Stenting ◽  
Endoscopic Biliary Drainage ◽  
Stent Patency ◽  
Malignant Biliary Stricture

Biliary and pancreatic cancers occur silently in the initial stage and become unresectable within a short time. When these diseases become symptomatic, biliary obstruction, either with or without infection, occurs frequently due to the anatomy associated with these cancers. The endoscopic management of these patients has changed, both with time and with improvements in medical devices. In this review, we present updated and integrated concepts for the endoscopic management of malignant biliary stricture. Endoscopic biliary drainage had been indicated in malignant biliary obstruction, but the concept of endoscopic management has changed with time. Although routine endoscopic stenting should not be performed in resectable malignant distal biliary obstruction (MDBO) patients, endoscopic biliary drainage is the treatment of choice for palliation in unresectable MDBO patients. Self-expanding metal stents (SEMS) have better stent patency and lower costs compared with plastic stents (PS). For malignant hilum obstruction, PS and uncovered SEMS yield similar short-term outcomes, while a covered stent is not usually used due to a potential unintentional obstruction of contralateral ducts.

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