Health Condition 1: K869- Disease of pancreas, unspecified Health Condition 2: null- To facilitate drainage of the pancreas in a broad range of settings commensurate with short term pancreatic plastic stenting, such as acute pancreatitis, duct leak, and stricture.
Conditions
Interventions
Intervention1: The Advanixâ?¢ Pancreatic Stent: NIL, as this is an implantable device
Control Intervention1: NIL, As this is a single arm study, there is no comparator agent: NIL, As this is a single
Sponsors
Boston Scientific Corporation
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation, provided no exclusion criterion is met. 1. Subjects age 18 or older. 2. Subjects who require pancreatic drainage and are amenable to endoscopic techniques. 3. Subjects willing and able to comply with the study procedures and follow up schedule and willing to provide written informed consent to participate in the study. 4. Subjects satisfying at least one of the following clinical presentations: a. high risk of acute pancreatitis post ERCP b. impaired pancreatic duct drainage and pain associated with a pancreatic duct dominant stricture and/or stones and/or sludge/debris, possibly before ESWL or before pancreatic surgery c. need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak d. need to maintain proper pancreatic duct drainage after surgical resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy
Exclusion criteria
Exclusion criteria: 1. Subjects for whom endoscopic techniques are contraindicated. 2. Subjects with known sensitivity to any components of the stents or delivery systems. 3. Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice 4. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor. 5. Subjects unable or refusing to comply with the follow-up schedule including subject living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group A Absence of acute pancreatitis Group B Absence of acute pancreatitis and where applicable improvement of pain at stent removal compared to baseline Group C Resolution of pancreatic duct leak Group D Absence of pancreatic duct leak and stricture Group E Resolution of the indication for stent placementTimepoint: Group A 48 hours post stent placement Group B through stent removal Group C stent removal Group D stent removal Group E stent removal | — |
Secondary
| Measure | Time frame |
|---|---|
| Documentation of stent migration rates overall, by Group, and by stent type.Timepoint: Through out study;Documenting stent type preference by subject presentation and pancreatic plastic stenting indication.Timepoint: Stent placement procedure;Evaluation of ease of use documenting overall ease of placement, pushability of stent and ability to visualize the stent fluoroscopically.Timepoint: Stent placement procedure;Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events.Timepoint: Stent removal;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.Timepoint: Stent placement procedure;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.Timepoint: Through end of follow-up;For subjects in Group B with a documented dominant pancreatic duct stricture at stent placement: Evaluation of stricture resolution at time of stent removal based on pancreatogramTimepoint: Stent removal procedure;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 pancreatitisTimepoint: Through out study | — |
Countries
Germany, India, Netherlands, United States of America
Contacts
Public ContactSandeep Lakhtakia MD
Asian Institute of Gastroenterology
Outcome results
None listed