Short Term Pancreatic Stenting Registry

NCT ID: NCT02262845

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 246 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-09-30

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A: PEP Risk

In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Used to drain pancreatic ducts

Group C: Pancreatic Duct Leak

In subjects with a pancreatic duct leak

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Used to drain pancreatic ducts

Group E: Other

In subjects with other indications

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

Intervention Type: DEVICE

Used to drain pancreatic ducts

Interventions

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

Used to drain pancreatic ducts

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Tarnasky, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Methodist Dallas Medical Center

Dallas, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Evangelisches Krankenhaus Dusseldorf

Düsseldorf, , Germany

Asian Institute of Gastroenterology

Somājigūda, Hyderabad, India

Erasmus Medical Center

Rotterdam, , Netherlands

Countries

United States; Germany; India; Netherlands

Other Identifiers

90987979

Identifier Type: -

Identifier Source: org_study_id