Pancreatic Metal Stents in Chronic Pancreatitis

Boston Scientific

Status: Completed

Conditions: Painful Chronic Pancreatitis; Refractory Pancreatic Duct Strictures

Treatments: Device: WallFlex Pancreatic Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02135809

E7093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

FCSEMS

Experimental group

Description:

Patients will receive the WallFlex Pancreatic Stent.

Treatment:

Device: WallFlex Pancreatic Stent