The purpose of this study is to document clinical utility and distribution of indications for short term pancreatic stenting, and stent type preference by indication at tertiary referral centers with expertise in pancreatic endotherapy.
The study is designed as an all-comer, prospective, multi-center, consecutive cohort series, open-label study. Detailed objective: To confirm the clinical utility of Advanix™ Pancreatic Stents when used per standard of practice to facilitate pancreatic duct drainage in the following clinical presentations: * Group A: PEP Risk - In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP) * Group B: Impaired Pancreatic Duct Drainage - In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery * Group C: Pancreatic Duct Leak - In subjects with a pancreatic duct leak * Group D: Post Pancreatic Surgery - In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy * Group E: Other - In subjects with other indications
Study Type
OBSERVATIONAL
Enrollment
246
Used to drain pancreatic ducts
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
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
Clinical Success: Group A (PEP Risk)
Absence of acute pancreatitis from stent placement through 48 hours post stent placement
Time frame: Stent placement through 48 hours post stent placement
Clinical Success: Group B (Impaired Pancreatic Duct Drainage)
Absence of acute pancreatitis from stent placement through stent removal and, where applicable, improvement of pain at stent removal compared to baseline
Time frame: Stent placement through stent removal
Clinical Success: Group C (Pancreatic Duct Leak):
Resolution of pancreatic duct leak at stent removal
Time frame: Stent Removal
Clinical Success: Group D (Post Pancreatic Surgery)
Absence of pancreatic duct leak and stricture at stent removal
Time frame: Stent Removal
Clinical Sucess: Group E (Other)
Resolution of the indication for stent placement at stent removal
Time frame: Stent Removal
Serious Adverse Events and all occurrences of acute pancreatitis
Occurrence and severity of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable and all occurrences of acute pancreatitis.
Time frame: Through end of study
Technical Success
Evaluation of technical success defined as the ability to place the stent in a satisfactory position in the main pancreatic duct as determined by fluoroscopy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Evangelisches Krankenhaus Dusseldorf
Düsseldorf, Germany
Asian Institute of Gastroenterology
Somājigūda, Hyderabad, India
Erasmus Medical Center
Rotterdam, Netherlands
Time frame: Stent Placement
Ease of use
Evaluation of ease of use documenting overall ease of placement, pushability of stent and ability to visualize the stent fluoroscopically.
Time frame: Stent Placement
Removability
Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events.
Time frame: Stent Removal
Stent Migration
Documentation of stent migration rates overall, by Group, and by stent type
Time frame: Through end of study
Reintervention
Evaluation of the occurrence of reintervention defined as any type of endoscopic, percutaneous, or surgical procedure to aid drainage of the pancreas after initial stent placement through end of follow-up.
Time frame: Through end of study
Stent type preference
Documenting stent type preference by subject presentation and pancreatic plastic stenting indication.
Time frame: Stent Placement