Pancreatic Metal Stents in Chronic Pancreatitis

NCT ID: NCT02135809

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-03-30

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.

Conditions

Refractory Pancreatic Duct Strictures; Painful Chronic Pancreatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FCSEMS

Patients will receive the WallFlex Pancreatic Stent.

Group Type: EXPERIMENTAL

WallFlex Pancreatic Stent

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

Jacques Devière, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ULB Erasme Hospital

Locations

ULB Erasme Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

E7093

Identifier Type: -

Identifier Source: org_study_id