VIABILITY: GORE® VIABIL® Biliary Endoprosthesis for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
Study Details
Study Description
Brief Summary
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A maximum of 15 clinical investigative sites across the U.S. will participate in this study. One hundred and twenty eight subjects are intended to be implanted with the GORE® VIABIL® Biliary Endoprosthesis in this study. Subjects will be evaluated at the time of device placement and will have follow-up visits at 1 week and 1, 3, 6, and 9 months during indwell; will have the device removed at 10-12 months and have post removal follow-up visits at 1 week and 1, 3, 6, 12 and 24 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GORE® VIABIL® Biliary Endoprosthesis GORE® VIABIL® Biliary Endoprosthesis |
Device: GORE® VIABIL® Biliary Endoprosthesis
Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with the GORE® VIABIL® Biliary Endoprosthesis.
Device: GORE® VIABIL® Short Wire Biliary Endoprosthesis
Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with GORE® VIABIL® Short Wire Biliary Endoprosthesis
|
Outcome Measures
Primary Outcome Measures
- Safe stent removal as reported by serious adverse event reporting [At removal (10-12 months)]
Ability to remove the endoprosthesis endoscopically without stent removal related serious adverse events (SAEs) as assessed from the time of stent removal to one (1) month post-stent removal.
Secondary Outcome Measures
- Placement success as determined by imaging [Day 0]
Ability to deploy stent in satisfactory position across the biliary stricture.
- Stent functionality as determined by adverse event reporting [During indwell up to 12 months]
Defined as freedom from device-related reintervention during intended indwell
- Migration as determined by imaging [During indwell up to 12 months]
Defined as movement of the stent such that the endoprosthesis is no longer in a satisfactory position across the biliary stricture during intended indwell
- Removal success as determined by imaging [At removal (10-12 months)]
Defined as either ability to remove the stent endoscopically at scheduled stent removal without stent removal-related SAEs or spontaneous stent passage without the need for immediate re-stenting
- Stricture resolution at stent removal as determined by imaging [At removal (10-12 months)]
Defined as freedom from recurrent stent placement at the end of indwell
- Stricture recurrence as determined by adverse event reporting [From removal up to 24 months]
Defined as any biliary stricture related re-intervention from the removal procedure through 2 years post-stent removal.
- Device- or procedure-related SAEs as determined by serious adverse event reporting [Day 0-13 months (including through 30 days post-removal)]
Defined as device- or procedure-related SAEs that occur during placement, indwell, or removal (including through 30 days post-removal).
- Liver Function as determined by alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase levels [Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)]
Including alkaline phosphatase (ALP, U/L), alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L) levels
- Liver Function as determined by direct bilirubin, and total bilirubin [Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)]
Including direct bilirubin (mg/dL), and total bilirubin (mg/dL) levels
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A diagnosis of chronic pancreatitis
-
Presence of a stricture as defined by a bile duct narrowing within the pancreatic head with resultant upstream dilation and an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range)
-
Indication(s) for bile duct drainage (one or more from the following list):
- Jaundice; ii. Cholangitis; iii. Choledocholithiasis
-
Underlying stricture malignancy has been reasonably excluded (e.g., by any of the following techniques - biopsy, Endoscopic Ultrasound [EUS], Computed Tomography [CT], or Magnetic Resonance Imaging [MRI] with or without Magnetic Resonance Cholangiopancreatography [MRCP]) ≤ 60 days prior to index procedure
-
≥ 18 years old at the time of informed consent signature
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Male, infertile female, or woman of childbearing potential with a negative beta Human Chorionic Gonadotropin (hCG) pregnancy test within 7 days of the index procedure
-
Able and willing to provide written informed consent (or has a Legally Authorized Representative) to participate in the study prior to any study procedures
-
Willing and able to comply with the study procedures and follow-up requirements
Radiographic Inclusion
Confirmed by imaging collected ≤ 60 days prior to the index procedure:
-
Confirmed biliary stricture by imaging (e.g., cholangiogram or CT) or planned exchange of multiple side-by-side plastic stents whose combined diameters are ≤ 20 French (Fr) that were previously placed for management of symptomatic Benign Biliary Strictures (BBS) due to chronic pancreatitis
-
Bismuth type I stricture classification (defined as a common bile duct or common hepatic duct stricture whose proximal margin is ≥ 2 cm from the hepatic bifurcation)
Exclusion Criteria:
-
Participated in another investigational study within 30 days prior to consent or while participating in this study
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A contraindication for endoscopic techniques
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Life expectancy < 2 years
-
A history of malignant biliary or malignant pancreatic disease
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Prior or existing biliary self-expanding metal stent
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Prior or planned exchange of multiple side-by-side plastic stents whose combined diameters are greater than 20 Fr
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Development of obstructive biliary symptoms associated with a present attack of acute pancreatitis
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Any biliary stricture etiology other than chronic pancreatitis
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Other concomitant therapeutic endoscopic procedures including planned Fine Needle Aspiration (FNA) or Fine Needle Biopsy (FNB) of the pancreas
Radiographic Exclusion
Confirmed by imaging collected ≤ 60 days prior to the index procedure:
-
Concomitant Bismuth type II-IV stricture
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Inability for the guidewire to traverse the papillae and the stricture (e.g., as a result of surgically altered anatomy)
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Symptomatic duodenal stenosis (with gastric stasis)
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Known bile duct fistula or leak
-
Biliary stricture length > 6 cm
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- W.L.Gore & Associates
Investigators
- Principal Investigator: Todd Baron, MD, University of North Carolina Medical Center
- Principal Investigator: Shayan Irani, MD, Virginia Mason Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VBL 22-01