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A NON-RANDOMIZED, MULTI-CENTER, PROSPECTIVE, SINGLE ARM CLINICAL STUDY OF THE
X-SUIT NIR® COVERED BILIARY METALLIC STENT FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE VIA ENDOSCOPIC APPROACH

The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.The objective of…

The use of covered expandable stents with a proximal lasso to resolve benign post-surgical biliary strictures

To investigate feasibility, safety, and effectiveness of covered expandable stents with a proximal lasso to resolve benign post-surgical strictures.

EUS-guided choledochoduodenostomy (versus ERCP) for primary drainage of malignant distal biliary obstruction: a pilot study

To establish the effectiveness and safety of EUS-CD as the primary drainage strategy in patients with malignant distal biliary obstruction.

Needle-knife fistulotomy (NKF) for primary biliary access in patients with choledocholithiasis; a *real world* prospective multicenter pilot study

To explore the safety and efficacy of NKF as the primary cannulation technique in patients with an indication for sphincterotomy in tertiary as well as teaching centers after standardized training on an ex-vivo ERCP model.

Stereotactic body radiation therapy after chemotherapy for unresectable perihilar cholangiocarcinoma: a multicenter phase II trial (The STRONG 2 trial)

To evaluate the efficacy of SBRT as additional treatment after standard care chemotherapy regarding tumor local control, toxicity, progression-free survival, overall survival and quality of life. In addition, to explore the value of immunodynamics…

Very short-course versus standard course antibiotic therapy in patients with acute ChOlangitis after
adequate endoscopic BiliaRy drAinage (COBRA trial).

The primary objective is to investigate if a very short-course of antibiotics for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics.

Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricture

To proof feasibility and safety of direct SEMS placement for palliative treatment of perihilar cholangiocarcinoma.

Primary percutaneous stenting of the bile ducts in patients with resectable perihilar cholangiocarcinoma - a pilot study

To analyse complications due to primary percutaneous stenting in patients with resectable pCCA.

Primary percutaneous stenting above the ampulla versus endoscopic drainage
for unresectable malignant hilar biliary obstruction.

To compare the efficacy of PPS above the ampulla to standard EBD in patients with MHBO who are ineligible for surgical resection.

A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, with an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects with Biliary Atresia.;Trial Acronym: ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE)

Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…

Prospective, Multi-center, Randomized Controlled Study Comparing
Endoscopic Clearance of Non-Complex Biliary Stones Using
Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to
Standard of Care Endoscopic Retrograde Cholangiography (ERC)

The aim of this study is to prospectively assess the benefits and effectiveness of non-complex gallstone clearancefluoroscopy / radiation-free direct solitary cholangioscopy (DSC) comparing the SpyGlass * system to non-complex biliary stone…