Clinical trial NCT02135809: 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
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Pancreatic Duct Strictures
Painful Chronic Pancreatitis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
timeFrame: 3 months after study stent removal
Secondary outcomes:
measure: Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal
timeFrame: Duration of study participation, an average of 27-30 months
measure: Stent placement success
timeFrame: Study Stent Placement Procedure
measure: Type of additional intervention within pancreatic duct
timeFrame: Duration of study participation, an average of 27-30 months
measure: Stent removal success
timeFrame: Study Stent Removal
measure: Change of pain medication intake
timeFrame: Duration of study participation, an average of 27-30 months
measure: Number of device events
timeFrame: Duration of study participation, an average of 27-30 months
measure: Stricture resolution of pancreatic duct after stent removal
timeFrame: Study Stent Removal
measure: For patients who proceed to surgery, impact of prior SEMS on surgical outcomes.
timeFrame: Up to surgery
measure: Stent functionality
timeFrame: Up to time of study stent removal,average of 3-6 months on study
measure: Stricture Resolution at stent removal
timeFrame: Study Stent Removal
measure: Time to Recurrence of Stricture
timeFrame: Duration of study participation, an average of 27-30 months
measure: Reason for additional intervention within pancreatic duct
timeFrame: Duration of study participation, an average of 27-30 months
measure: Timing of additional intervention within pancreatic duct
timeFrame: Duration of study participation, an average of 27-30 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ULB Erasme Hospital
Study officials:
affiliation: ULB Erasme Hospital
name: Jacques Devière, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: