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

NCT ID: NCT05820009

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2028-08-01

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.

Conditions

Pancreatitis, Chronic; Stricture; Bile Duct

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GORE® VIABIL® Biliary Endoprosthesis

GORE® VIABIL® Biliary Endoprosthesis

Group Type: EXPERIMENTAL

GORE® VIABIL® Biliary Endoprosthesis

Intervention Type: DEVICE

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

GORE® VIABIL® Short Wire Biliary Endoprosthesis

Intervention Type: DEVICE

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

Interventions

GORE® VIABIL® Biliary Endoprosthesis

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

Intervention Type: DEVICE

GORE® VIABIL® Short Wire Biliary Endoprosthesis

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Baron, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina Medical Center

Shayan Irani, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

UNC School of Medicine

Chapel Hill, North Carolina, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

VBL 22-01

Identifier Type: -

Identifier Source: org_study_id