Malignant Biliary Obstruction
Conditions
Brief summary
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.
Interventions
DEVICEEUS access device
The intervention involves the use of an EUS access device to gain access to the bile duct via hepaticogastrostomy.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with malignant biliary obstruction and who is indicated to receive EUS-guided hepaticogastrostomy for biliary drainage, as documented by dilated left hepatic duct and hyperbilirubinemia * Patient who failed ERCP (e.g., inability to access the obstructed biliary system via a transpapillary route) or for whom ERCP is not an option (e.g., due to altered anatomy, gastric outlet obstruction) * 18 years of age or older * Patient willing and able to provide written informed consent and comply with specified study visits
Exclusion criteria
* Patient whose general medical condition and degree of respiratory failure would not allow them to tolerate endoscopy and/or the manipulation required to perform the study procedure * Abnormal coagulopathy: * INR >1.5 and not correctable * presence of bleeding disorder * platelets <50,000 mm3 * Patient with contraindication to use of electrical devices * Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study * Patient from a vulnerable population * Current participation in another investigational drug or device study that could interfere with the endpoints of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Day 0 Study Procedure | 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 |
| Safety | Day 0 Study Procedure through Day 7 Post-Study Procedure | Study device- and study procedure-related serious adverse events |
| Device Performance | Day 0 Study Procedure | 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 |
Countries
Belgium, France, India
Outcome results
None listed