Prospective multicentre trial on efficacy and safety of percutaneous transhepatic deployment (PTD) & endoscopic retrograde deployment (ERD) of an ePTFE lined nitinol biliary self expanding metal stent (SEMS)

2001 ◽  
Vol 96 (9) ◽  
pp. S84
Author(s):  
J CUNNIGHAM2
Keyword(s):  
Multicentre Trial ◽  
Efficacy And Safety ◽  
Metal Stent ◽  
Endoscopic Retrograde

Abstract 16775: Efficacy and Safety of a Thinner-strut Silicon Carbide-coated Cobalt Chromium Bare-metal Stent Compared to a Thin-strut Uncoated Cobalt Chromium Bare-metal Stent in Large Vessel Stenting: Insights From Two Prospective Randomised All-comers Trials

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Kim W Hansen ◽  
Rikke Sørensen ◽  
Raban Jeger ◽  
Christoph Kaiser ◽  
Matthias Pfisterer ◽  
...  
Keyword(s):  
Silicon Carbide ◽  
Cardiac Death ◽  
Bare Metal Stent ◽  
Bare Metal ◽  
Target Vessel ◽  
Efficacy And Safety ◽  
Cobalt Chromium ◽  
Metal Stent ◽  
Target Vessel Revascularization ◽  
New Generation

Introduction: The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest reduced efficacy with higher rates of symptomatic restenosis in patients receiving the newer generation BMS. Objective: We investigated the efficacy and safety of a new generation thinner-strut SiC coated CoCr BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0mm) and thus at low risk of restenosis. Methods: We included all patients randomized to SCC- (n=761) or UC-BMS (n=765) in the BASKET-PROVE II and I trials, respectively. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis were also assessed. We used Cox proportional hazards regressions to estimate relative hazards adjusting for known confounders. Results: Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. Rates of the primary endpoint were 10.4% in the SCC-BMS group and 8.4% among patients receiving UC-BMS yielding an adjusted relative hazard (HR) of 1.46 ([1.03-2.07], p=0.032). Estimates for the safety endpoints were: cardiac death (1.8% vs. 2.4% ; HR 0.77 [0.36-1.59], p=0.46), non-fatal MI (3.2% vs. 2.5% ; HR 1.68 [0.88-3.21], p=0.11), and definite/probable stent thrombosis (0.8% vs. 1.0% ; HR 0.97 [0.32-3.00], p=0.96). We detected no particular subgroups driving the increased risk of target-vessel revascularization in the SCC-BMS group. Conclusions: In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of symptomatic restenosis despite less complex procedures compared to the UC-BMS with no signs of an offsetting safety benefit.

scholarly journals The Efficacy and Safety of Balloon Enteroscopy-Assisted Endoscopic Retrograde Cholangiography in Pediatric Patients with Surgically Altered Gastrointestinal Anatomy

2021 ◽  
Vol 10 (17) ◽  
pp. 3936
Author(s):  
Kensuke Yokoyama ◽  
Tomonori Yano ◽  
Atsushi Kanno ◽  
Eriko Ikeda ◽  
Kozue Ando ◽  
...  
Keyword(s):  
Success Rate ◽  
Pediatric Patients ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Endoscopic Retrograde Cholangiography ◽  
Adult Patients ◽  
Efficacy And Safety ◽  
Duodenal Papilla ◽  
Endoscopic Retrograde ◽  
Balloon Enteroscopy

Balloon enteroscopy-assisted endoscopic retrograde cholangiography (BEA-ERC) is useful and feasible in adults with pancreatobiliary diseases, but its efficacy and safety have not been established in pediatric patients. We compared the success rate and safety of BEA-ERC between adults and pediatric patients. This single-center retrospective study reviewed 348 patients (pediatric: 57, adult: 291) with surgically altered gastrointestinal anatomies who underwent BEA-ERC for biliary disorders from January 2007 to December 2019. The success rate of reaching the anastomosis or duodenal papilla was significantly lower in pediatric patients than in adult patients (66.7% vs. 88.0%, p < 0.01). The clinical success rate was also significantly lower in pediatric patients (64.9% vs. 80.4%, p = 0.014). The rate of adverse events was significantly higher in pediatric patients than in adults (14.2% vs. 7.7%, p = 0.037). However, if the anastomotic sites were reached in pediatric patients, the treatment was highly successful (97.3%). The time of reaching target site was significantly longer in pediatric patients than in adult patients. This study shows that BEA-ERC in pediatric patients is more difficult than that in adult patients. However, in patients where the balloon enteroscope was advanced to the anastomosis, clinical outcomes comparable to those in adults can be achieved.

scholarly journals Three Cases of Difficult Bile Duct Stone Removal by EUS-guided Choledochoduodenostomy

2020 ◽  
Vol 25 (2) ◽  
pp. 128-134
Author(s):  
Yeong Joo Jeong ◽  
Man Ki Choi ◽  
Seung Goun Hong
Keyword(s):  
Bile Duct ◽  
Common Bile Duct ◽  
Hospital Stay ◽  
Bile Duct Stone ◽  
Intrahepatic Bile Duct ◽  
Safe Procedure ◽  
Bile Duct Stones ◽  
Metal Stent ◽  
Endoscopic Retrograde ◽  
Duration Of Hospital Stay

After failed removal of common bile duct or intrahepatic bile duct (IHD) stones by endoscopic retrograde cholangiopancreatography (ERCP), percutaneous lithotripsy is well-known as an effective procedure. However, it is time-consuming because multiple sessions of transhepatic tract dilatation are required. Endoscopic ultrasound (EUS)-guided choledochoduodenostomy (CDS) has been recently used to approach IHD to remove difficult bile duct stones. We recently experienced EUS-guided CDS performed with metal stent. Common bile duct or IHD stones were removed by retrieval accessories after initial failed or inadequate ERCP in three patients. Serious complications including bleeding, infection, and perforation were not noted. The duration of hospital stay from EUS-guided procedure to discharge ranged from 10 to 14 days. Although this result is interim and ongoing, it suggests that EUS-guided CDS might be an effective and safe procedure after failed ERCP to remove difficult bile duct stones through the tract.

scholarly journals ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yen-I Chen ◽  
◽  
Kashi Callichurn ◽  
Avijit Chatterjee ◽  
Etienne Desilets ◽  
...  
Keyword(s):  
Endoscopic Ultrasound ◽  
Biliary Drainage ◽  
Biliary Obstruction ◽  
Locally Advanced ◽  
Endoscopic Drainage ◽  
Metal Stent ◽  
Ultrasound Guided ◽  
Endoscopic Retrograde ◽  
Promising Alternative ◽  
Randomized Controlled

Abstract Background & aims Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction. Methods The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. Discussion The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design. Trial registration Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.

Sign in / Sign up

Export Citation Format

Share Document