Short Term Pancreatic Stenting Registry

NCT02262845 | Completed

• 1 other identifier: 90987979
• Study Type: observational
• Target: 246
• Locations: 4 countries
• Sites: 7

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.

Conditions

Post-ERCP Acute Pancreatitis; Pancreatic Duct Stricture; Pancreatic Duct Stones; Pancreatic Duct Leakage

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Serious Adverse Events and all occurrences of acute pancreatitis

  Through end of study

• Technical Success

  Stent Placement

• Ease of use

  Stent Placement

• Removability

  Stent Removal

• Stent Migration

  Through end of study

Study Arms (5)

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

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

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

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

Group E: Other

In subjects with other indications

Device: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers

Interventions

The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers DEVICE

Used to drain pancreatic ducts

Group A: PEP Risk; Group B: Impaired Pancreatic Duct Drainage; Group C: Pancreatic Duct Leak; Group D: Post Pancreatic Surgery; Group E: Other

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75208, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Evangelisches Krankenhaus Dusseldorf

Düsseldorf, 40217, Germany

Location

Asian Institute of Gastroenterology

Somājigūda, Hyderabad, 500 082, India

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Study Officials

• Paul Tarnasky, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 13, 2014
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IN (1); NL (1); US (4)