Short Term Pancreatic Stenting Registry

Study Overview
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Brief Summary
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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
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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

Official Title
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A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct

Conditions
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Post-ERCP Acute Pancreatitis, Pancreatic Duct Stricture, Pancreatic Duct Stones, Pancreatic Duct Leakage

Intervention / Treatment
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* Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 18 or older. Subjects who require pancreatic drainage and are amenable to endoscopic techniques. 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. Subjects satisfying at least one of the following clinical presentations: high risk of acute pancreatitis post ERCP 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 need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak 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: Subjects for whom endoscopic techniques are contraindicated. Subjects with known sensitivity to any components of the stents or delivery systems. Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: PEP Risk<br>In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP) | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers<br>* Used to drain pancreatic ducts<br>|
| Group B: Impaired Pancreatic Duct Drainage<br>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 | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers<br>* Used to drain pancreatic ducts<br>|
| Group C: Pancreatic Duct Leak<br>In subjects with a pancreatic duct leak | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers<br>* Used to drain pancreatic ducts<br>|
| Group D: Post Pancreatic Surgery<br>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 | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers<br>* Used to drain pancreatic ducts<br>|
| Group E: Other<br>In subjects with other indications | Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers<br>* Used to drain pancreatic ducts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success: Group A (PEP Risk) | Absence of acute pancreatitis from stent placement through 48 hours post stent placement | 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 | Stent placement through stent removal | 
| Clinical Success: Group C (Pancreatic Duct Leak): | Resolution of pancreatic duct leak at stent removal | Stent Removal | 
| Clinical Success: Group D (Post Pancreatic Surgery) | Absence of pancreatic duct leak and stricture at stent removal | Stent Removal | 
| Clinical Sucess: Group E (Other) | Resolution of the indication for stent placement at stent removal | Stent Removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Stent Placement | 
| Removability | Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events. | Stent Removal | 
| Stent Migration | Documentation of stent migration rates overall, by Group, and by stent type | 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. | Through end of study | 
| Stent type preference | Documenting stent type preference by subject presentation and pancreatic plastic stenting indication. | Stent Placement |