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

NCT05820009 | Suspended DMC FDA Device

• 1 other identifier: VBL 22-01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 2

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).

Conditions

Pancreatitis, Chronic; Stricture; Bile Duct

Keywords

Benign Bile Duct Stricture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Placement success as determined by imaging

  Day 0

• Stent functionality as determined by adverse event reporting

  During indwell up to 12 months

• Migration as determined by imaging

  During indwell up to 12 months

• Removal success as determined by imaging

  At removal (10-12 months)

• Stricture resolution at stent removal as determined by imaging

  At removal (10-12 months)

Study Arms (1)

GORE® VIABIL® Biliary Endoprosthesis

EXPERIMENTAL

GORE® VIABIL® Biliary Endoprosthesis

Device: GORE® VIABIL® Biliary Endoprosthesis; Device: GORE® VIABIL® Short Wire Biliary Endoprosthesis

Interventions

GORE® VIABIL® Biliary Endoprosthesis DEVICE

Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with the GORE® VIABIL® Biliary Endoprosthesis.

GORE® VIABIL® Biliary Endoprosthesis

GORE® VIABIL® Short Wire Biliary Endoprosthesis DEVICE

Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with GORE® VIABIL® Short Wire Biliary Endoprosthesis

GORE® VIABIL® Biliary Endoprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of chronic pancreatitis
• Indication for ERCP with FCSEMS placement determined by one or more of the following:
• 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)
• 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)
• 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
• 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
• 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

You may not qualify if:

• Concurrent participation in another interventional study that involves an investigational product being introduced to the body
• A contraindication for endoscopic techniques
• Life expectancy \< 2 years
• A history of malignant biliary or malignant pancreatic disease
• Prior or existing biliary self-expanding metal stent (SEMS)
• Prior or planned exchange of multiple side-by-side plastic stents whose combined diameters are greater than 20 Fr
• Development of obstructive biliary symptoms associated with a present attack of acute pancreatitis
• Any biliary stricture etiology other than chronic pancreatitis
• 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
• Concomitant Bismuth type II-IV stricture
• Inability for the guidewire to traverse the papillae and the stricture (e.g., as a result of surgically altered anatomy)
• Inability to pass the endoscope to the papillae without the need for mechanical dilation
• Known bile duct fistula or leak
• Biliary stricture length \> 100 mm (10 cm)

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (2)

UNC School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Todd Baron, MD

  University of North Carolina Medical Center

  PRINCIPAL INVESTIGATOR

• Shayan Irani, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 19, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)