To prospectively document the performance of a FCSEMS for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.
This study is a prospective, single arm, pre-approval study. Treatment of up to 92 patients will take place at up to 15 clinical centers. Patient who meet all eligibility criteria will receive the WallFlex Pancreatic stent for up to 6 months stent indwell and 6 months follow-up after stent removal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.
University of Colorado School of Medicine
Aurora, Colorado, United States
Indiana University Health Medical Center
Indianapolis, Indiana, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Pain Reduction
The self-reported pain score (0-100) was the mean of the Visual Analogue Scale (VAS) and Izbicki Frequency of Pain subscore (sum treated as a continuous variable).The primary efficacy endpoint was the proportion of patients who had complete (pain score ≤ 10) or partial (pain score ˃ 10 but reduced at least 50% compared to pain as baseline) pain relief by 6 months after FCSEMS removal or observation of CDM or partial stent migration. Primary efficacy endpoint failure included any of the following: 1) no pain relief, 2) complete or partial pain relief in the setting of a 50% higher average daily narcotic dose compared to the patient's daily average narcotic dose in the month prior to baseline and at 6 months post-stent removal/observation of CDM, 3) stent migration in setting of recurring pain (VAS Pain Score of ≥ 20), 4) restenting in the setting of recurring pain.
Time frame: Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
Rate of Related SAEs From WallFlex Pancreatic Stent Placement to End of Study
The primary safety endpoint was the rate of serious adverse events (SAEs) related to the FCSEMS or study procedures from FCSEMS placement to end of study follow-up. Pain thought to be caused by FCSEMS pancreatic stent expansion was reported but did not count towards the endpoint if all three of the following conditions applied: 1. Pain managed by medication, with the exception of injectable narcotic use for more than 24 hours. 2. Pain not causing pancreatic FCSEMS removal. 3. Pain resolved by 72 hours after pancreatic FCSEMS placement.
Time frame: Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
Stent Placement Success
Satisfactory position is defined as the stent being across the stricture, without visible occluding impaction at the genu of the pancreatic duct and with distal end of the stent visible in the duodenum.
Time frame: Assessed upon study stent placement. This endpoint is assessed at the Study Stent Placement visit (Day 0).
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Medical University of South Carolina
Charleston, South Carolina, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
ULB Erasme Hospital
Brussels, Belgium
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, India
Policlinico A. Gemelli
Rome, Italy
...and 1 more locations
Endoscopic Stent Removal Success
Endoscopic stent removal success is defined as ability to remove stent endoscopically (forceps, snare) without serious stent removal-related adverse events.
Time frame: Assessed at study stent removal or observation of complete or partial stent migration. This is endpoint is assessed through the Month 6 Study Stent Removal visit.
Stent Migration Rate
Stent migration is the change in location of a stent from its originally placed location. In this study, pancreatic stent migration was noted as partial or complete and either proximal (i.e., into the pancreas) or distal (i.e., out of the pancreas).
Time frame: Study stent placement through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
Restenting Rate
Restenting is the placement of a non-study stent due to no improvement in clinical status and associated persistence of stricture following removal or complete distal migration of the study stent.
Time frame: Study stent removal or observation of study stent migration through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
Secondary Stricture Rate
A secondary stricture is a ductal narrowing located at the intraductal edge of the study stent.
Time frame: Study stent placement through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration