Pancreatic Metal Stents in Chronic Pancreatitis

July 8, 2019 updated by: Boston Scientific Corporation

Fully Covered Self Expanding Metal Stents (FCSEMS) for Refractory Pancreatic Duct Strictures in Patients With Chronic Pancreatitis

The purpose of this study is to document the performance of a new Fully Covered Self Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis.

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

This study is a prospective, single arm, pre-approval study. Treatment of 10 patients will take place at 1-3 clinical centers in two phases. Phase 1 will include treatment of five patients with a three month stent indwell period at one clinical center. Phase 2 will include treatment of five additional patients with a 3-6 month stent indwell period at 1-3 clinical centers. Expected duration of participation for each patient is approximately 27 months for Phase 1 and approximately 27-30 months for Phase 2. All patients, regardless of phase, will be followed for 24 months after stent removal. Post-removal follow-up visits will occur at 1, 3, 6, 12, 18 and 24 months.

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.
Interventional

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.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Belgium
      • Brussels, Belgium, B-1070
        • ULB Erasme Hospital

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

Description

Inclusion Criteria:

  1. Age 18 or older
  2. Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
  3. Chronic pancreatitis of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications.
  4. Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent

  5. At least one of the following:

    • Abdominal pain most probably related to chronic pancreatitis
    • Recurrent dominant main pancreatic duct stricture in the head of the pancreas after prior indwell of pancreatic plastic stent(s) if pain score was available prior to preceding stent therapy. Recurrent stricture to be visually assessed at endoscopy and confirmed by recurrent main pancreatic duct dilatation at MRCP.
    • Relapsing pain due to pancreatic duct stent blockage (with only one stent in place)
  6. Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement with informed patient consent.

Exclusion Criteria:

  1. Strictures caused by malignancies
  2. Biliary strictures caused by chronic pancreatitis
  3. Perforated duct.
  4. Ansa pancreatica or H anatomy
  5. Pancreatic duct stenoses not located in the head of the pancreas
  6. Failed access during an attempted ERCP on a prior date
  7. Prior pancreatic metal stent(s)
  8. Concurrent ESWL (Extracorporeal Shock Wave Lithotripsy) during the same treatment session
  9. Patients for whom endoscopic techniques are contraindicated.
  10. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
  11. Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational center that

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: FCSEMS
Patients will receive the WallFlex Pancreatic Stent.
Device: WallFlex Pancreatic Stent
Temporary placement of the WallFlex Pancreatic Stent for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis. Stent will be removed after 3-6 months indwell.

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
Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
Time Frame: 3 months after study stent removal
Clinical success defined as decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis 3 months after stent removal compared to baseline prior to stent indwell period.
3 months after study 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
Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal
Time Frame: Duration of study participation, an average of 27-30 months
Duration of study participation, an average of 27-30 months
Stent placement success
Time Frame: Study Stent Placement Procedure
Ability to deploy the stent in satisfactory position (Stent Placement Success). Satisfactory position is defined as the stent being across the stricture, without visible impaction at an angle and distal end visible into the duodenum.
Study Stent Placement Procedure
Type of additional intervention within pancreatic duct
Time Frame: Duration of study participation, an average of 27-30 months
Duration of study participation, an average of 27-30 months
Stent removal success
Time Frame: Study Stent Removal
Successful stent removal (Stent Removal Success) defined as ability to remove stent endoscopically (grasper, snare, stent-in-stent) without serious stent removal-related adverse events
Study Stent Removal
Change of pain medication intake
Time Frame: Duration of study participation, an average of 27-30 months
Change of pain medication intake (type of medication) from baseline to each follow-up visit.
Duration of study participation, an average of 27-30 months
Number of device events
Time Frame: Duration of study participation, an average of 27-30 months
Device Events, including findings not associated with adverse events, such as but not limited to asymptomatic stent migration.
Duration of study participation, an average of 27-30 months
Stricture resolution of pancreatic duct after stent removal
Time Frame: Study Stent Removal
Assessment of pancreatic duct after stent removal compared to baseline, including ERCP to document extent of stricture resolution, extent of resolution of ductal dilation above the treated dominant stricture, and presence or absence of secondary ductal strictures at the level of where the proximal edge of the stent was located
Study Stent Removal
For patients who proceed to surgery, impact of prior SEMS on surgical outcomes.
Time Frame: Up to surgery
Up to surgery
Stent functionality
Time Frame: Up to time of study stent removal,average of 3-6 months on study
Stent functionality: Relief of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis at 3 days, 2 weeks, 1 month, 2 months, 4 months (Phase 2 patients as applicable) and just prior to stent removal compared to baseline prior to stent placement, using established pancreatic pain score
Up to time of study stent removal,average of 3-6 months on study
Stricture Resolution at stent removal
Time Frame: Study Stent Removal
Stricture Resolution at stent removal, defined as pancreatographic confirmation of drainage of injected contrast medium after stent removal without visible persistent stricture
Study Stent Removal
Time to Recurrence of Stricture
Time Frame: Duration of study participation, an average of 27-30 months
Time to Recurrence of Stricture, established in patients who had stricture resolution at stent removal and defined as time elapsed from stent removal till recurrence of pain with associated documentation of narrowing of pancreatic duct. Recurrence of stricture will be documented at the time it is identified and absence of stricture recurrence will be ascertained at 1, 3, 6, 12, 18 and 24 months after stent removal. Pain will be documented using an established pancreatic pain score.
Duration of study participation, an average of 27-30 months
Reason for additional intervention within pancreatic duct
Time Frame: Duration of study participation, an average of 27-30 months
Duration of study participation, an average of 27-30 months
Timing of additional intervention within pancreatic duct
Time Frame: Duration of study participation, an average of 27-30 months
Duration of study participation, an average of 27-30 months

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: Jacques Deviere, MD, PhD, ULB Erasme Hospital

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.
June 1, 2014

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.
June 1, 2015

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.
March 30, 2017

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).
May 2, 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.
May 8, 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.
May 12, 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.
July 9, 2019

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.
July 8, 2019

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.
July 1, 2019

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.
  • E7093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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