GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis (VIABILITY)

Evaluation of the GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis

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).

Study Overview

• Status: Suspended
• Conditions: Pancreatitis, Chronic; Stricture; Bile Duct
• Intervention / Treatment: Device: GORE® VIABIL® Biliary Endoprosthesis; Device: GORE® VIABIL® Short Wire Biliary Endoprosthesis

Detailed Description

A maximum of 15 clinical investigative sites across the U.S. will participate in this study. One hundred and thirty-three 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; subjects 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 Type: Interventional
• Enrollment (Estimated): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC School of Medicine
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. A diagnosis of chronic pancreatitis

2. Indication for ERCP with FCSEMS placement determined by one or more of the following:

   1. Presence of a Bismuth type I BBS confirmed by imaging (e.g., cholangiography, Computed Tomography [CT], Magnetic Resonance Cholangiopancreatography [MRCP], etc.) collected ≤ 60 days prior to the index procedure and an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range)
   2. Presence of a symptomatic (e.g., jaundice, cholangitis, and/or choledocholithiasis) Bismuth type I BBS confirmed by imaging (e.g., cholangiography, CT, MRCP, etc.) collected ≤ 60 days prior to the index procedure with an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range)
   3. A planned exchange of multiple side-by-side plastic stents (whose combined diameters are ≤ 20 Fr) that were previously placed for management of a Bismuth type I BBS secondary to chronic pancreatitis
3. 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
4. ≥ 18 years old at the time of informed consent signature
5. 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
6. Able and willing to provide written informed consent (or has a Legally Authorized Representative) to participate in the study prior to any study procedures
7. Willing and able to comply with the study procedures and follow-up requirements

Exclusion Criteria

1. Concurrent participation in another interventional study that involves an investigational product being introduced to the body
2. A contraindication for endoscopic techniques
3. Life expectancy < 2 years
4. A history of malignant biliary or malignant pancreatic disease
5. Prior or existing biliary self-expanding metal stent (SEMS)
6. Prior or planned exchange of multiple side-by-side plastic stents whose combined diameters are greater than 20 Fr
7. Development of obstructive biliary symptoms associated with a present attack of acute pancreatitis
8. Any biliary stricture etiology other than chronic pancreatitis
9. Other therapeutic endoscopic procedures performed during the index or removal procedure that are not associated with bile duct stricture secondary to Chronic Pancreatitis including but not limited to planned Fine Needle Aspiration (FNA) or Fine Needle Biopsy (FNB) of the pancreas
10. Concomitant Bismuth type II-IV stricture
11. Inability for the guidewire to traverse the papillae and the stricture (e.g., as a result of surgically altered anatomy)
12. Inability to pass the endoscope to the papillae without the need for mechanical dilation
13. Known bile duct fistula or leak
14. Biliary stricture length > 100 mm (10 cm)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safe stent removal as reported by serious adverse event reporting	Ability to remove the Study Device endoscopically without stent removal-related serious adverse events (SAEs) as assessed from the time of Study Device removal to one month (30 days) post-Study Device removal.	At removal (10-12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stricture resolution at stent removal as determined by imaging	Defined as freedom from recurrent stent placement at the end of indwell	At removal (10-12 months)
Liver Function as determined by alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase levels	Including alkaline phosphatase (ALP, U/L), alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L) 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)
Liver Function as determined by direct bilirubin, and total bilirubin	Including direct bilirubin (mg/dL), and total bilirubin (mg/dL) 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)
Placement success as determined by imaging	Ability to deploy the Study Device in a satisfactory position across the biliary stricture.	Day 0
Stent functionality as determined by adverse event reporting	Defined as freedom from Study Device-related reintervention during intended indwell	During indwell up to 12 months
Migration as determined by imaging	Defined as movement of the Study Device such that the Study Device is no longer in a satisfactory position across the biliary stricture during intended indwell.	During indwell up to 12 months
Removal success as determined by imaging	Defined as either ability to remove the Study Device endoscopically at scheduled Study Device removal without stent removal-related SAEs or spontaneous Study Device passage without the need for immediate re-stenting	At removal (10-12 months)
Stricture recurrence as determined by adverse event reporting	Defined as any biliary stricture-related re-intervention from the removal procedure through 2 years post-Study Device removal.	From removal up to 24 months
Device- or procedure-related SAEs as determined by serious adverse event reporting	Defined as Study Device- or procedure-related SAEs that occur during placement, indwell, or removal (including through 30 days post-removal).	Day 0-13 months (including through 30 days post-removal)

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Benign Bile Duct Stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Pancreatic Diseases; Chronic Disease; Constriction, Pathologic; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: VBL 22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes