Safety and outcomes of endoscopic ultrasound-guided drainage for malignant biliary obstruction using cautery-enabled lumen-apposing metal stent

Abstract Background and study aims There is increasing evidence to suggest that EUS-guided biliary drainage (EUS-BD) is a safe and effective treatment alternative for patients with malignant biliary obstructions (MBOs) after failed endoscopic retrograde cholangiopancreatography. Patients and methods We performed a retrospective analysis of data prospectively collected from patients with MBO who underwent choledochoduodenostomy (CDS) or gallbladder drainage (GBD) between August 2016 and June 2020 using the electrocautery-enabled lumen-apposing metal stents (ECE-LAMS). The primary endpoint was technical and clinical success. Secondary endpoints were adverse events (AEs) and reinterventions. Results A total of 60 patients were included in the study, with 56 CDS and 4 GBD. Median age was 76 years with 57 % male (34/60). The most common indication for EUS-BD was pancreatic cancer (78 %). Technical success was achieved in 100 % of cases, with a clinical success rate of 91.7 %. Mean total bilirubin pre-procedure was 202 umol/L (normal < 20 umol/L) and 63.8 umol/L post procedure (P < .001). Twenty-one patients had bilirubin recorded at 2 weeks post EUS-BD with 20 of 21 patients demonstrating > 50 % reduction in bilirubin (mean bilirubin reduction 75 %). AEs occurred in 12 of 60 patients (20 %), all of which were mild. The reintervention rate was 11.7 % (7/60). Stent occlusion occurred in 10 of 60 patients (16.7 %) with a mean time to stent occlusion of 46.2 days (3–133). Stent patency of 83.3 % was observed with a mean follow up of 7.9 months. Conclusion EUS-CDS and GBD using ECE-LAMS are effective EUS-based techniques for managing patients with MBO. AEs are usually mild and resolved by reintervention.

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Endoscopic deployment of multiple (≥ 3) metal stents for unresectable malignant hilar biliary strictures

Endoscopy International Open ◽

10.1055/a-0849-9334 ◽

2019 ◽

Vol 07 (05) ◽

pp. E672-E677

Author(s):

Tatsuya Koshitani ◽

Shuji Nakagawa ◽

Yoshitomo Konaka ◽

Keimei Nakano ◽

Shuichi Fuki ◽

...

Keyword(s):

Obstructive Jaundice ◽

Clinical Success ◽

Guide Wire ◽

Metal Stents ◽

High Grade ◽

Success Rates ◽

Biliary Strictures ◽

Stent Patency ◽

Stent Occlusion

Abstract Background and study aims Endoscopic deployment of multiple (≥ 3) self-expandable metal stents (SEMS) for high-grade unresectable malignant hilar biliary strictures (UMHBS) is technically challenging. Eleven consecutive patients with high-grade UMHBS (mean age: 76 years, male/female: 5/6, Bismuth-Corlette classification IIIa/IV: 7/4) underwent endoscopic deployment of multiple SEMS using a combination of side-by-side (SBS) and stent-in-stent (SIS) methods. Technical and clinical success rates were 11/11. More than three SEMS were successfully deployed, and obstructive jaundice was fully improved in all cases. Stent occlusion was recognized in four of 11 patients (mean: 134 days, range: 28 – 232). Reinterventions for both liver lobes were feasible by passing the guide wire inside the previously placed stents in three of four patients. Median stent patency was 150 days during a mean follow-up period of 184 days (range: 37 – 558). Three patients developed self-limiting cholangitis without definite stent occlusion as late (> 30 days) adverse events. Employing the combination of SBS and SIS methods may facilitate endoscopic deployment of multiple SEMS to treat high-grade UMHBS.

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Outcomes of the Use of Fully Covered Esophageal Self-Expandable Stent in the Management of Colorectal Anastomotic Strictures and Leaks

Diagnostic and Therapeutic Endoscopy ◽

10.1155/2014/187541 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 7

Author(s):

Chad J. Cooper ◽

Angel Morales ◽

Mohamed O. Othman

Keyword(s):

Anastomotic Leak ◽

Clinical Success ◽

Anastomotic Stricture ◽

Clinical Success Rate ◽

Stent Migration ◽

Metal Stents ◽

The Novel ◽

Anastomotic Leaks ◽

Anastomotic Strictures

Introduction. Colorectal anastomotic leak or stricture is a dreaded complication leading to significant morbidity and mortality. The novel use of self-expandable metal stents (SEMS) in the management of postoperative colorectal anastomotic leaks or strictures can avoid surgical reintervention. Methods. Retrospective study with particular attention to the indications, operative or postoperative complications, and clinical outcomes of SEMS placement for patients with either a colorectal anastomotic stricture or leak. Results. Eight patients had SEMS (WallFlex stent) for the management of postoperative colorectal anastomotic leak or stricture. Five had a colorectal anastomotic stricture and 3 had a colorectal anastomotic leak. Complete resolution of the anastomotic stricture or leak was achieved in all patients. Three had recurrence of the anastomotic stricture on 3-month flexible sigmoidoscopy follow-up after the initial stent was removed. Two of these patients had a stricture that was technically too difficult to place another stent. Stent migration was noted in 2 patients, one at day 3 and the other at day 14 after stent placement that required a larger 23 mm stent to be placed. Conclusions. The use of SEMS in the management of colorectal anastomotic leaks or strictures is feasible and is associated with high technical and clinical success rate.

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Self-Expanding Metal Stenting for Palliation of Patients with Malignant Colonic Obstruction: Effectiveness and Efficacy on 255 Patients with 12-Month's Follow-up

Gastroenterology Research and Practice ◽

10.1155/2012/296347 ◽

2012 ◽

Vol 2012 ◽

pp. 1-6 ◽

Cited By ~ 16

Author(s):

Søren Meisner ◽

Ferran González-Huix ◽

Jo G. Vandervoort ◽

Alessandro Repici ◽

Dimitrios Xinopoulos ◽

...

Keyword(s):

Stent Placement ◽

Clinical Success ◽

Colonic Obstruction ◽

Metal Stents ◽

Control Group ◽

Metal Stent ◽

Multicenter Studies ◽

Malignant Colonic Obstruction ◽

Procedural Success

Background. Self-expanding metal stents can alleviate malignant colonic obstruction in incurable patients and avoid palliative stoma surgery.Objective. Evaluate stent effectiveness and safety on palliation of patients with malignant colorectal strictures.Design. Two prospective, one Spanish and one global, multicenter studies.Settings. 39 centers (22 academic, 17 community hospitals) from 13 countries.Patients. A total of 257 patients were enrolled, and 255 patients were treated with a WallFlex uncovered enteral colonic stent. Follow-up was up to 12 months or until death or retreatment.Interventions(s). Self-expanding metal stent placement.Main Outcome Measures. Procedural success, clinical success, and safety.Results. Procedural success was 98.4% (251). Clinical success rates were 87.8% at 30 days, 89.7% at 3 months, 92.8% at 6 months, and 96% at 12 months. Overall perforation rate was 5.1%. Overall migration rate was 5.5%. Overall death rate during follow-up was 48.6% (124), with 67.7% of deaths related to the patient’s colorectal cancer, unrelated in 32.3%. Only 2 deaths were related to the stent or procedure.Limitations. No control group.Conclusions. The primary palliative option for patients with malignant colonic obstruction should be self-expanding metal stent placement due to high rates of technical success and efficacy in symptom palliation and few complications.

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PRECLINICAL EVALUATION OF THE VASCULAR EFFECTS OF REJUVENATE® COBALT CHROMIUM CORONARY STENT SYSTEM IMPLANTED IN THE PORCINE CORONARY IN STENT RESTENOSIS MODEL

Pakistan Heart Journal ◽

10.47144/phj.v54i2.2087 ◽

2021 ◽

Vol 54 (2) ◽

pp. 132-138

Author(s):

Murtaza Najabat Ali ◽

Mariam Mir ◽

Piotr Buszman

Keyword(s):

Vascular Tissue ◽

Bare Metal Stents ◽

Bare Metal Stent ◽

Metal Stents ◽

Bare Metal ◽

Cobalt Chromium ◽

Metal Stent ◽

Stent Patency ◽

The Mean

Objectives: The main objective of the study was to evaluate the implantation, safety, and vascular tissue effects of REJUVENATE® Cobalt Chromium Bare Metal Stent in the Porcine Coronary Restenosis model at short, mid and long-term follow up. Methodology: A total of 18 REJUVENATE® bare metal stents (CoCr, 95 µm strut thickness) were implanted into the coronary arteries (RCA, LCX and LAD) of the six pigs. Throughout the study period, stent patency, vascular response, percent stenosis, late lumen loss and performance of stent were evaluated by angiography, optical coherence tomography (OCT), and Histopathology (includes both Histopathology and histomorphometry) at 30, 90, and 180 days and compared with the results of control Bare Metal Stent Coflexus®. The mean, variance and standard deviation was analyzed using SPSS software. Results: OCT and QCA analysis demonstrated two cases of binary restenosis at 30 days follow-up and two at 90 days follow-up (33%). The mean area stenosed for Rejuvenate® was 34% as compared to 24% of Coflexus® and at 180 days follow up, it decreased to 21%. The histopathology analysis demonstrated favorable safety with acceptable levels of neointimal formation, with decreased levels of inflammation and complete endothelialization in 180 days. Conclusion: This study proved the potential safety of REJUVENATE® in porcine model and supports that this stent can move forward for the human trials.

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What is the Impact of the Proportion of Solid Necrotic Content on the Number of Necrosectomies during EUS-Guided Drainage using Lumen-Apposing Metallic Stents of Pancreatic Walled-off Necrosis ?

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld-3128 ◽

2020 ◽

Vol 29 (4) ◽

pp. 623-628

Author(s):

Andrada Seicean ◽

Cristina Pojoga ◽

Ofelia Mostean ◽

Sorana Bolboaca ◽

Madalina Ilie ◽

...

Keyword(s):

Pancreatic Necrosis ◽

Clinical Success ◽

Metal Stents ◽

Metal Stent ◽

Endoscopic Necrosectomy ◽

Medical Centers ◽

One Step ◽

Walled Off Necrosis ◽

The Impact

Background and Aims: The fully-covered, lumen apposing metal stents are designed for one step placement, facilitating the direct endoscopic necrosectomy into the walled-off pancreatic necrosis. However, the prediction of the number of necrosectomy sessions in these patients is not known. This study evaluated the association between the proportion of solid necrotic material inside walled-off necrosis, as assessed during the endosonography placement of a lumen apposing metal stent, and the number of necrosectomies subsequently required. Methods: Patients from three tertiary medical centers with symptomatic walled off pancreatic necrosis (pain, infection, gastric/biliary obstruction) at more than 4 weeks after onset of acute pancreatitis were retrospectively analysed. Proportion of solid necrotic debris was estimated during endosonography procedure of lumen apposing metal stents placement. Necrosectomy was performed when obstruction or inflammation occurred subsequently. Lumen apposing metal stents were removed after clearance of necrotic content. Results: In 46 patients with successful lumen apposing metal stents placement, necrosectomy was performed in 39 patients (72.78%). Performance of 3 or more necrosectomies was significantly associated with more than 50% pancreatic necrosis (p=0.032), but not with walled-off pancreatic necrosis size or location. Necrotic infection during lumen apposing metal stents stenting was associated with hypoalbuminemia, but not with necrosectomy requirement. Clinical success after a median follow-up of 13.37 months was 87%. Conclusions: Walled-off pancreatic necrosis with more than 50% solid necrotic content were associated with more necrosectomy procedures, requiering longer endoscopy time, intravenous sedations, and higher costs.

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Portal vein stent placement with or without varix embolization of jejunal variceal bleeding after hepatopancreatobiliary surgery

Acta Radiologica ◽

10.1177/0284185116654329 ◽

2016 ◽

Vol 58 (4) ◽

pp. 423-429 ◽

Cited By ~ 3

Author(s):

Dong Jae Shim ◽

Ji Hoon Shin ◽

Gi-Young Ko ◽

Yook Kim ◽

Kichang Han ◽

...

Keyword(s):

Portal Vein ◽

Stent Placement ◽

Variceal Bleeding ◽

Clinical Success ◽

Recurrent Bleeding ◽

Technical Success ◽

Stent Patency ◽

Stent Occlusion ◽

Before And After

Background Extrahepatic portal hypertension after surgery involving the duodenum or jejunum might result in massive ectopic variceal bleeding. Purpose To report the results of portal vein stent placement with the addition of variceal embolization. Material and Methods Between January 2000 and June 2015, portal vein stent placement was attempted in 477 patients. Of these, 22 patients (age, 63 ± 10 years) with jejunal variceal bleeding caused by portal vein obstruction after surgery were included in this study. Computed tomography (CT) findings before and after treatment and the rates of technical and clinical success, complications, and clinical outcomes were retrospectively evaluated. Results Stent placement was successful in 19 of 22 patients. Additional variceal embolization was performed in five cases. Clinical success, defined as the cessation of bleeding without recurrence within 1 month, was achieved in 18 of 19 patients with technical success. One patient developed recurrent bleeding 4 days after stent placement and was successfully treated with additional variceal embolization. There were no procedure-related complications. A regression of the jejunal varices was noted in 14 of 19 patients on follow-up CT scans. During the follow-up period (258 days; range, 7–1196 days), stent occlusion and recurrent bleeding occurred in six and four patients, respectively, of the 19 patients who achieved technical success. Statistical analyses revealed no significant differences regarding stent patency between benign and malignant strictures. Conclusion Percutaneous, transhepatic, portal vein stent placement with or without jejunal variceal embolization appears to be a safe and effective treatment for jejunal variceal bleeding after surgery.

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Biosafety of a novel covered self-expandable metal stent coated with poly(2-methoxyethyl acrylate) in vivo

PLoS ONE ◽

10.1371/journal.pone.0257828 ◽

2021 ◽

Vol 16 (9) ◽

pp. e0257828

Author(s):

Tetsuya Ishizawa ◽

Naohiko Makino ◽

Yasuharu Kakizaki ◽

Akiko Matsuda ◽

Yoshihide Toyokawa ◽

...

Keyword(s):

Bile Ducts ◽

Histological Analysis ◽

Inflammatory Marker ◽

Metal Stents ◽

Endoscopic Biliary Drainage ◽

Metal Stent ◽

Endoscopic Retrograde ◽

Serological Examination

Covered self-expandable metal stents (CSEMS) are often used for palliative endoscopic biliary drainage; however, the unobstructed period is limited because of sludge occlusion. The present study aimed to evaluate the biosafety of a novel poly(2-methoxyethyl acrylate)-coated CSEMS (PMEA-CSEMS) for sludge resistance and examine its biosafety in vivo. Using endoscopic retrograde cholangiopancreatography, we placed the PMEA-CSEMS into six normal porcine bile ducts and conventional CSEMS into three normal porcine bile ducts. We performed serological examination and undecalcified histological analysis at 1, 3, and 6 months during follow-up. In the bile ducts with PMEA-CSEMS or conventional CSEMS, we observed no increase in liver enzyme or inflammatory marker levels in the serological investigations and mild fibrosis but no inflammatory response in the histopathological analyses. Thus, we demonstrated the biosafety of PMEA-CSEMS in vivo.

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Endovenous radiofrequency powered segmental thermal ablation (Closure FAST) of great saphenous veins

Phlebologie ◽

10.1055/s-0037-1622301 ◽

2010 ◽

Vol 39 (02) ◽

pp. 69-71 ◽

Cited By ~ 6

Author(s):

T. M. Proebstle ◽

Keyword(s):

Side Effects ◽

Thermal Ablation ◽

Clinical Success ◽

Clinical Success Rate ◽

Duplex Ultrasound ◽

Multicenter Trial ◽

Saphenous Veins ◽

Clinical Control ◽

Prospective Multicenter Trial

Summary Background: Radiofrequency powered segmental thermal ablation Closure FAST has become a globally engaged technology for ablation of incompetent great saphenous veins (GSVs). Mid-term results of slowly resolving side effects are still not described. Methods: RSTA-treated GSVs (n = 295) were followed for 24 months in a prospective multicenter trial. Clinical control visits included flow and reflux analysis by duplex-ultrasound and assessment of treatment related side effects at all times. Results: 280 of 295 treated GSVs (94.9%) were available for 24 months follow-up. According to the method of Kaplan and Meier at 24 months after the intervention 98.6% of treated legs remained free of clinically relevant axial reflux. The average VCSS score improved from 3.9 ± 2.1 at screening to 0.7 ± 1.2 at 24 months follow-up (p < 0.0001). While only 41.1% of patients were free of pain before treatment, at 24 months 99.3% reported no pain and 96.4% did not experience pain during the 12 months before. At 24 months n=3 legs showed pigmentation along the inner thigh and one leg showed study-treatment related paresthesia. Conclusion: Radiofrequency powered segmental thermal ablation Closure FAST showed a very moderate side-effect profile in conjunction with a high and durable clinical success rate.

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Ferric sulfate as pulpotomy agent in primary teeth: twenty month clinical follow-up

Journal of Clinical Pediatric Dentistry ◽

10.17796/jcpd.24.4.d7u6405nw1132705 ◽

2000 ◽

Vol 24 (4) ◽

pp. 269-272 ◽

Cited By ~ 28

Author(s):

Hamijeta Ibricevic ◽

Qumasha Al-Jame

Keyword(s):

Success Rate ◽

Primary Teeth ◽

Root Resorption ◽

Clinical Success ◽

Clinical Success Rate ◽

Ferric Sulfate ◽

Primary Molar ◽

Molar Teeth ◽

The Moment

Seventy primary molar teeth, carious exposed, symptom free, without any sign of root resorption in children aged from 3 to 6 years (main age 4.3yr) were treated with conventional pulpotomy procedures. Ferric sulfate 15.5% solution (applied for 15 second for 35 teeth) and formocresol solution (five minute procedure of Buckley's formula for next 35 teeth) have been used as pulpotomy agents. In both groups, pulp stumps were covered with zinc-oxide eugenol paste. Permanent restorations were stainless steel crowns. Clinical check up was every three-months and radiographic follow-up time was six and twenty months after treatment. Our results within this period revealed 100% clinical success rate in both groups. Radiographic success rate was in both groups 97.2%, while in 2.8% cases has shown internal root resorption. On the basis of these results, we can recommend ferric sulfate as a pulpotomy agent in primary teeth in substitution for formocresol at the moment.

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Revascularization versus apical barrier technique with mineral trioxide aggregate plug: A systematic review

Giornale Italiano di Endodonzia ◽

10.4081/j.gien.2018.10 ◽

2018 ◽

Vol 32 (1) ◽

pp. 9-16 ◽

Cited By ~ 3

Author(s):

Luiz Alexandre Chisini ◽

Guillermo Grazioli ◽

Alejandro Francia ◽

Alissa Schmidt San Martin ◽

Flavio Fernando Demarco ◽

...

Keyword(s):

Clinical Success ◽

Mineral Trioxide Aggregate ◽

Clinical Success Rate ◽

Permanent Teeth ◽

Radiographic Outcomes ◽

Bias Risk ◽

Radiographic Measurements ◽

High Bias ◽

The Mean

Aim: To compare the clinical and radiographic outcomes observed in Necrotic Immature Permanent Teeth (NIPT) after revascularization or apexification with MTA-apical plug. Methodology: PubMed/MEDLINE, Web of science and Scopus were the databases used, up to July 30th, 2017, for article research. Independent reviewers read the titles and abstracts of all reports that met inclusion/exclusion criteria: prospective or retrospective clinical studies comparing the revascularization of root canal and apexification. Clinical success of therapies, deposition and thickening of lateral dentinal walls (root width) and the continuation of root development (root length) were investigated. Bias risk of included studies was assessed using the Cochrane risk of bias. Results: From 1642 records, five papers fulfilled all inclusion criteria. Overall, 91 teeth were submitted to revascularization and 64 teeth to apexification with MTA. The mean follow-up was 23.2 months in revascularization and 21.8 in apexification. Clinical success rate was of 87.9% in the revascularization group and 90.6% in the apexification group. An increase on lateral dentinal walls thickening was observed in most revascularization cases (13%) while MTA as apical plug suggest a mild resorption of the root (1.3%). High bias risk was observed on included studies. Conclusions: Apexification with MTA-apical plug provides similar clinical success to revascularization. However, radiographic measurements showed an improvement in thickening of lateral dentinal walls in most of the revascularization cases in addition to a higher dental development. However, these results should be interpreted with caution.

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