Biliary Obstruction, Chronic Pancreatitis, Pancreatic Cancer Non-resectable, Pancreatic Duct Obstruction, Pancreatic Fluid Collections
Conditions
Keywords
EUS-guided bile duct drainage, EUS-guided pancreatogastrostomy, Endoscopic ultrasound
Brief summary
This is a prospective study of patients undergoing EUS procedures using the RIVOS™ EUS access device.
Detailed description
Endoscopic ultrasound (EUS)-guided interventions are becoming the first-line treatment of various pancreaticobiliary disorders such as malignant biliary obstruction, access to bile duct or pancreatic duct after failed ERCP, and drainage of pancreatic, peripancreatic or intraabdominal fluid collections. However, given the lack of dedicated devices for performing these complex interventions, accessories used to perform endoscopic retrograde cholangiopancreatography (ERCP) are currently being used off-label to perform most interventional EUS procedures. The RIVOS™ EUS access device is a novel, FDA approved device that has been specifically developed for performing EUS-guided interventions. The device has a sharp trocar tip to allow access to the target organ, a flexible access cannula to allow contrast injection and passage of a guidewire, and an electrocautery-tip to facilitate the creation of a fistula. This innovative design is expected to simplify the technical aspects of the procedure and improve the safety profile for these complex endoscopic interventions. The aim of this study is to evaluate the technical and treatment outcomes in patients undergoing standard of care, interventional EUS-guided procedures in patients with pancreaticobiliary disorders using the RIVOS™ EUS access device.
Interventions
DEVICEEUS-guided intervention using the RIVOS™ EUS access device
EUS-guided intervention using the RIVOS™ EUS access device
Sponsors
Orlando Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * All patients undergoing EUS-guided interventions using the RIVOS™ EUS access device
Exclusion criteria
* Age \< 18 years * Patients who did not undergo EUS-guided interventions using the RIVOS™ EUS access device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 1 day | Rate of technical success in patients undergoing EUS-guided procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success | 4 weeks | Rate of treatment success, defined as the resolution of symptoms and/or radiological findings from underlying disease at 4-weeks following index intervention. |
| Adverse events | 4 weeks | Rate of adverse events, procedure-related and disease-related, in patients undergoing endoscopic ultrasound procedures. |
| Procedure duration | 1 day | Total procedure duration, defined as time taken from start of the EUS-procedure to time the echoendoscope is withdrawn from the patient. |
| Hospital admission | 4 weeks | Rate of hospital admission due to disease-related symptoms or procedure-related adverse events. |
Countries
United States
Contacts
CONTACTJi Young Bang, MD MPH
CONTACTBarbara J Broome
Outcome results
None listed