Short Term Pancreatic Stenting Registry

Completed

• Conditions: Pancreatic Duct Stones; Pancreatic Duct Leakage; Pancreatic Duct Stricture; Post-ERCP Acute Pancreatitis
• Interventions: Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers

• Registration Number: NCT02262845
• Lead Sponsor: Boston Scientific Corporation

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

Study Timeline

• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-13
• Study Start: 2015-02
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B: Impaired Pancreatic Duct Drainage	The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers	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 E: Other	The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers	In subjects with other indications
Group A: PEP Risk	The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers	In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)
Group C: Pancreatic Duct Leak	The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers	In subjects with a pancreatic duct leak
Group D: Post Pancreatic Surgery	The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
Stent Migration	Through end of study	Documentation of stent migration rates overall, by Group, and by stent type
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.
Stent type preference	Stent Placement	Documenting stent type preference by subject presentation and pancreatic plastic stenting indication.

Trial Locations

Locations (7)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Asian Institute of Gastroenterology; 🇮🇳 Somajiguda, Hyderabad, India

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Evangelisches Krankenhaus Dusseldorf; 🇩🇪 Duesseldorf, Germany

Temple University School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States