The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for biliary drainage. The main questions it aims to answer are: * Can the device be used to gain and maintain access to target anatomy? * Does the device have a clinically acceptable safety profile? * How does the device perform overall? All patients will undergo a hepaticogastrostomy procedure and be followed for 7 days post-procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
The intervention involves the use of an EUS access device to gain access to the bile duct via hepaticogastrostomy.
Ghent University Hospital
Ghent, Belgium
Georges Pompidou European Hospital
Paris, France
Asian Institute of Gastroenterology
Hyderabad, Telangana, India
Technical Success
Defined as (1) access of the target biliary duct, as confirmed via imaging, (2) ability to advance a wire to guide the procedure through the access cannula after the sharp is removed, and (3) ability to create a cautery fistula for accessory device passage
Time frame: Day 0 Study Procedure
Safety
Study device- and study procedure-related serious adverse events
Time frame: Day 0 Study Procedure through Day 7 Post-Study Procedure
Device Performance
Evaluated per the following criteria (1) ability to gain access to the target structure, (2) ability to maintain access to the target structure, (3) ability to visualize device during necessary procedural steps, and (4) ability to create a cautery fistula for accessory device passage
Time frame: Day 0 Study Procedure
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