Safety and effectiveness of a long, partially covered metal stent for endoscopic ultrasound-guided hepaticogastrostomy in patients with malignant biliary obstruction

Endoscopy ◽  
2016 ◽  
Vol 48 (12) ◽  
pp. 1125-1128 ◽  
Author(s):  
Yousuke Nakai ◽  
Hiroyuki Isayama ◽  
Natsuyo Yamamoto ◽  
Saburo Matsubara ◽  
Yukiko Ito ◽  
...  
Keyword(s):  
Endoscopic Ultrasound ◽  
Biliary Obstruction ◽  
Malignant Biliary Obstruction ◽  
Metal Stent ◽  
Ultrasound Guided

Endoscopic ultrasound-guided transduodenal placement of a fully covered metal stent for palliative biliary drainage in patients with malignant biliary obstruction

2010 ◽  
Vol 25 (2) ◽  
pp. 549-555 ◽  
Author(s):  
Ali A. Siddiqui ◽  
Jayaprakash Sreenarasimhaiah ◽  
Luis F. Lara ◽  
William Harford ◽  
Calvin Lee ◽  
...  
Keyword(s):  
Endoscopic Ultrasound ◽  
Biliary Drainage ◽  
Biliary Obstruction ◽  
Malignant Biliary Obstruction ◽  
Metal Stent ◽  
Ultrasound Guided

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.

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