Overview

This trial is active, not recruiting.

Conditions refractory pancreatic duct strictures, painful chronic pancreatitis
Treatment wallflex pancreatic stent
Sponsor Boston Scientific Corporation
Start date June 2014
End date September 2014
Trial size 10 participants
Trial identifier NCT02135809, 90895329

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
time frame: 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
time frame: Duration of study participation, an average of 27-30 months
Type of additional intervention within pancreatic duct
time frame: Duration of study participation, an average of 27-30 months
Stent placement success
time frame: Study Stent Placement Procedure
Stent removal success
time frame: Study Stent Removal
Change of pain medication intake
time frame: Duration of study participation, an average of 27-30 months
Number of device events
time frame: Duration of study participation, an average of 27-30 months
Stricture resolution of pancreatic duct after stent removal
time frame: Study Stent Removal
For patients who proceed to surgery, impact of prior SEMS on surgical outcomes.
time frame: Up to surgery
Stent functionality
time frame: Up to time of study stent removal,average of 3-6 months on study
Stricture Resolution at stent removal
time frame: Study Stent Removal
Time to Recurrence of Stricture
time frame: Duration of study participation, an average of 27-30 months
Reason for additional intervention within pancreatic duct
time frame: Duration of study participation, an average of 27-30 months
Timing of additional intervention within pancreatic duct
time frame: Duration of study participation, an average of 27-30 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Fully Covered Self Expanding Metal Stents (FCSEMS) for Refractory Pancreatic Duct Strictures in Patients With Chronic Pancreatitis
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.