Short Term Pancreatic Stenting Registry

March 20, 2017 updated by: Boston Scientific Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Success: Group A (PEP Risk)
Time Frame: Stent placement through 48 hours post stent placement
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)
Time Frame: 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
Stent placement through stent removal
Clinical Success: Group C (Pancreatic Duct Leak):
Time Frame: Stent Removal
Resolution of pancreatic duct leak at stent removal
Stent Removal
Clinical Success: Group D (Post Pancreatic Surgery)
Time Frame: Stent Removal
Absence of pancreatic duct leak and stricture at stent removal
Stent Removal
Clinical Sucess: Group E (Other)
Time Frame: Stent Removal
Resolution of the indication for stent placement at stent removal
Stent Removal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Events and all occurrences of acute pancreatitis
Time Frame: 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.
Through end of study
Technical Success
Time Frame: 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 Placement
Ease of use
Time Frame: Stent Placement
Evaluation of ease of use documenting overall ease of placement, pushability of stent and ability to visualize the stent fluoroscopically.
Stent Placement
Removability
Time Frame: Stent Removal
Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events.
Stent Removal
Stent Migration
Time Frame: Through end of study
Documentation of stent migration rates overall, by Group, and by stent type
Through end of study
Reintervention
Time Frame: 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.
Through end of study
Stent type preference
Time Frame: Stent Placement
Documenting stent type preference by subject presentation and pancreatic plastic stenting indication.
Stent Placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Tarnasky, MD, Methodist Dallas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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