Pancreatic Metal Stents in Chronic Pancreatitis

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: Completed
• Conditions: Refractory Pancreatic Duct Strictures; Painful Chronic Pancreatitis
• Intervention / Treatment: Device: WallFlex Pancreatic Stent

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: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	3 months after study stent removal

Secondary Outcome Measures

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		Duration of study participation, an average of 27-30 months
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.	Study Stent Placement Procedure
Type of additional intervention within pancreatic duct		Duration of study participation, an average of 27-30 months
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	Study Stent Removal
Change of pain medication intake	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	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	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.		Up to surgery
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	Up to time of study stent removal,average of 3-6 months on study
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	Study Stent Removal
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.	Duration of study participation, an average of 27-30 months
Reason for additional intervention within pancreatic duct		Duration of study participation, an average of 27-30 months
Timing of additional intervention within pancreatic duct		Duration of study participation, an average of 27-30 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Jacques Deviere, MD, PhD, ULB Erasme Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: May 2, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Constriction, Pathologic; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: E7093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No