Pancreatic Duct Leakage, Pancreatic Duct Stones, Pancreatic Duct Stricture, Post-ERCP Acute Pancreatitis
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEThe Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers
Used to drain pancreatic ducts
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: 1. high risk of acute pancreatitis post ERCP 2. 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 3. need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak 4. 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
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 | Description |
|---|---|---|
| Clinical Success: Group A (PEP Risk) | Stent placement through 48 hours post stent placement | Absence of acute pancreatitis from stent placement through 48 hours post stent placement |
| Clinical Success: Group B (Impaired Pancreatic Duct Drainage) | Stent placement through stent removal | Absence of acute pancreatitis from stent placement through stent removal and, where applicable, improvement of pain at stent removal compared to baseline |
| Clinical Success: Group C (Pancreatic Duct Leak): | Stent Removal | Resolution of pancreatic duct leak at stent removal |
| Clinical Success: Group D (Post Pancreatic Surgery) | Stent Removal | Absence of pancreatic duct leak and stricture at stent removal |
| Clinical Sucess: Group E (Other) | Stent Removal | Resolution of the indication for stent placement at stent removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reintervention | Through end of study | 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. |
| Serious Adverse Events and all occurrences of acute pancreatitis | Through end of study | 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. |
| Stent type preference | Stent Placement | Documenting stent type preference by subject presentation and pancreatic plastic stenting indication. |
| Technical Success | Stent Placement | 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. |
| Ease of use | Stent Placement | Evaluation of ease of use documenting overall ease of placement, pushability of stent and ability to visualize the stent fluoroscopically. |
| Removability | Stent Removal | Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events. |
| Stent Migration | Through end of study | Documentation of stent migration rates overall, by Group, and by stent type |
Countries
Germany, India, Netherlands, United States
Outcome results
None listed