Pancreatitis, Chronic, Stricture; Bile Duct
Conditions
Keywords
Benign Bile Duct Stricture
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.
Interventions
Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with the GORE® VIABIL® Biliary Endoprosthesis.
DEVICEGORE® VIABIL® Short Wire Biliary Endoprosthesis
Endoscopic treatment of benign biliary stricture secondary to Chronic Pancreatitis with GORE® VIABIL® Short Wire Biliary Endoprosthesis
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safe stent removal as reported by serious adverse event reporting | At removal (10-12 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent functionality as determined by adverse event reporting | During indwell up to 12 months | Defined as freedom from Study Device-related reintervention during intended indwell |
| Migration as determined by imaging | During indwell up to 12 months | 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. |
| Removal success as determined by imaging | At removal (10-12 months) | 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 |
| 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 |
| Placement success as determined by imaging | Day 0 | Ability to deploy the Study Device in a satisfactory position across the biliary stricture. |
| Device- or procedure-related SAEs as determined by serious adverse event reporting | Day 0-13 months (including through 30 days post-removal) | Defined as Study 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 |
| 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-Study Device removal. |
Countries
United States
Outcome results
None listed