Abstract
Background & aimsEndoscopic 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.MethodsThe 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.DiscussionThe 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 registrationRegistry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.
Highlights
Background & aimsEndoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices
ERCP has been the standard of care over the past four decades, the transpapillary route is associated with the risk of post-ERCP pancreatitis (PEP) while the insertion of a metal stent through the tumor can lead to subsequent stent dysfunction secondary to tumor tissue stent ingrowth and/or overgrowth in 20 to 40% of the patients [1,2,3,4,5]
Technical and clinical success was similar between modalities; rates of reintervention favored EUS-BD over ERCP (RR 0.40; 95% Confidence interval (CI) 0.29–094) and percutaneous biliary tube drain insertion (PTBD) (RR 0.49; 95% CI, 0.28–0.88)
Summary
Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); 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. EUS-BD through the transluminal approach is especially adapted to managing malignant distal biliary obstruction since a biliary bypass is created with a stent either through a choledochoduodenostomy (CDS) from the duodenal bulb or a hepatogastrostomy, thereby limiting the risk for PEP and stent tumor tissue ingrowth or overgrowth [6]. Cohort studies have shown encouraging results [10,11,12]; prospective trials, let alone randomized trials, are lacking
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