Short Term Pancreatic Stenting Registry

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 246

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40217
    • Evangelisches Krankenhaus Düsseldorf
• India
  • Hyderabad
    • Somajiguda, Hyderabad, India, 500 082
      • Asian Institute of Gastroenterology
• Netherlands
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medical Center
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University School of Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75208
      • Methodist Dallas Medical Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will examine how well the Advanix Pancreatic stent helps drainage of the pancreas when used per standard-of-practice in many different situations.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: PEP Risk; 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; Used to drain pancreatic ducts
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	Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers; Used to drain pancreatic ducts
Group C: Pancreatic Duct Leak; In subjects with a pancreatic duct leak	Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers; Used to drain pancreatic ducts
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	Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers; Used to drain pancreatic ducts
Group E: Other; In subjects with other indications	Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers; Used to drain pancreatic ducts

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Paul Tarnasky, MD, Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 90987979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No