Pancreatic Metal Stents in Chronic Pancreatitis

NCT02135809 | Completed

• 1 other identifier: E7093
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Pancreatic Duct Strictures; Painful Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

  Study Stent Placement Procedure

• Type of additional intervention within pancreatic duct

  Duration of study participation, an average of 27-30 months

• Stent removal success

  Study Stent Removal

• Change of pain medication intake

  Duration of study participation, an average of 27-30 months

Study Arms (1)

FCSEMS

EXPERIMENTAL

Patients will receive the WallFlex Pancreatic Stent.

Device: WallFlex Pancreatic Stent

Interventions

WallFlex Pancreatic Stent 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.

FCSEMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
• Chronic pancreatitis of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications.
• Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent
• 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)
• Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement with informed patient consent.

You may not qualify if:

• Strictures caused by malignancies
• Biliary strictures caused by chronic pancreatitis
• Perforated duct.
• Ansa pancreatica or H anatomy
• Pancreatic duct stenoses not located in the head of the pancreas
• Failed access during an attempted ERCP on a prior date
• Prior pancreatic metal stent(s)
• Concurrent ESWL (Extracorporeal Shock Wave Lithotripsy) during the same treatment session
• Patients for whom endoscopic techniques are contraindicated.
• Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
• Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational center that

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

ULB Erasme Hospital

Brussels, B-1070, Belgium

Location

Study Officials

• Jacques Devière, MD, PhD

  ULB Erasme Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 12, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: March 30, 2017
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)