Clinical trial NCT05820009: GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
Official title: Evaluation of the GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pancreatitis, Chronic
Stricture; Bile Duct
Keywords: Benign Bile Duct Stricture
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Safe stent removal as reported by serious adverse event reporting
timeFrame: At removal (10-12 months)
Secondary outcomes:
measure: Placement success as determined by imaging
timeFrame: Day 0
measure: Stent functionality as determined by adverse event reporting
timeFrame: During indwell up to 12 months
measure: Migration as determined by imaging
timeFrame: During indwell up to 12 months
measure: Removal success as determined by imaging
timeFrame: At removal (10-12 months)
measure: Stricture resolution at stent removal as determined by imaging
timeFrame: At removal (10-12 months)
measure: Stricture recurrence as determined by adverse event reporting
timeFrame: From removal up to 24 months
measure: Device- or procedure-related SAEs as determined by serious adverse event reporting
timeFrame: Day 0-13 months (including through 30 days post-removal)
measure: Liver Function as determined by alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase levels
timeFrame: Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)
measure: Liver Function as determined by direct bilirubin, and total bilirubin
timeFrame: Baseline, indwell follow-up visits (up to 12 months), at removal (10-12 months), and post-removal follow up visits (up to 24 months)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC School of Medicine
state: North Carolina
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: University of North Carolina Medical Center
name: Todd Baron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Mason Medical Center
name: Shayan Irani, MD
role: PRINCIPAL_INVESTIGATOR
References: