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Pancreatic Metal Stents in Chronic Pancreatitis

Primary Purpose

Refractory Pancreatic Duct Strictures, Painful Chronic Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
WallFlex Pancreatic Stent
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Pancreatic Duct Strictures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ULB Erasme Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FCSEMS

Arm Description

Patients will receive the WallFlex Pancreatic Stent.

Outcomes

Primary Outcome Measures

Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
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.

Secondary Outcome Measures

Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal
Stent placement success
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.
Type of additional intervention within pancreatic duct
Stent removal success
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
Change of pain medication intake
Change of pain medication intake (type of medication) from baseline to each follow-up visit.
Number of device events
Device Events, including findings not associated with adverse events, such as but not limited to asymptomatic stent migration.
Stricture resolution of pancreatic duct after 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
For patients who proceed to surgery, impact of prior SEMS on surgical outcomes.
Stent functionality
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
Stricture Resolution at stent removal
Stricture Resolution at stent removal, defined as pancreatographic confirmation of drainage of injected contrast medium after stent removal without visible persistent stricture
Time to Recurrence of Stricture
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.
Reason for additional intervention within pancreatic duct
Timing of additional intervention within pancreatic duct

Full Information

First Posted
May 2, 2014
Last Updated
July 8, 2019
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02135809
Brief Title
Pancreatic Metal Stents in Chronic Pancreatitis
Official Title
Fully Covered Self Expanding Metal Stents (FCSEMS) for Refractory Pancreatic Duct Strictures in Patients With Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Pancreatic Duct Strictures, Painful Chronic Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FCSEMS
Arm Type
Experimental
Arm Description
Patients will receive the WallFlex Pancreatic Stent.
Intervention Type
Device
Intervention Name(s)
WallFlex Pancreatic Stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
Description
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.
Time Frame
3 months after study stent removal
Secondary Outcome Measure Information:
Title
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
Title
Stent placement success
Description
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.
Time Frame
Study Stent Placement Procedure
Title
Type of additional intervention within pancreatic duct
Time Frame
Duration of study participation, an average of 27-30 months
Title
Stent removal success
Description
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
Time Frame
Study Stent Removal
Title
Change of pain medication intake
Description
Change of pain medication intake (type of medication) from baseline to each follow-up visit.
Time Frame
Duration of study participation, an average of 27-30 months
Title
Number of device events
Description
Device Events, including findings not associated with adverse events, such as but not limited to asymptomatic stent migration.
Time Frame
Duration of study participation, an average of 27-30 months
Title
Stricture resolution of pancreatic duct after stent removal
Description
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
Time Frame
Study Stent Removal
Title
For patients who proceed to surgery, impact of prior SEMS on surgical outcomes.
Time Frame
Up to surgery
Title
Stent functionality
Description
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
Time Frame
Up to time of study stent removal,average of 3-6 months on study
Title
Stricture Resolution at stent removal
Description
Stricture Resolution at stent removal, defined as pancreatographic confirmation of drainage of injected contrast medium after stent removal without visible persistent stricture
Time Frame
Study Stent Removal
Title
Time to Recurrence of Stricture
Description
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.
Time Frame
Duration of study participation, an average of 27-30 months
Title
Reason for additional intervention within pancreatic duct
Time Frame
Duration of study participation, an average of 27-30 months
Title
Timing of additional intervention within pancreatic duct
Time Frame
Duration of study participation, an average of 27-30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study Chronic pancreatitis of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications. Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent 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) Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement with informed patient consent. Exclusion Criteria: Strictures caused by malignancies Biliary strictures caused by chronic pancreatitis Perforated duct. Ansa pancreatica or H anatomy Pancreatic duct stenoses not located in the head of the pancreas Failed access during an attempted ERCP on a prior date Prior pancreatic metal stent(s) Concurrent ESWL (Extracorporeal Shock Wave Lithotripsy) during the same treatment session Patients for whom endoscopic techniques are contraindicated. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational center that
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Devière, MD, PhD
Organizational Affiliation
ULB Erasme Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ULB Erasme Hospital
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Pancreatic Metal Stents in Chronic Pancreatitis

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