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Pancreatic Metal Stents in Chronic Pancreatitis

CompletedNot applicableNCT02135809
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Fully Covered Self Expanding Metal Stents (FCSEMS) for Refractory Pancreatic Duct Strictures in Patients With Chronic Pancreatitis
Conditions
  • Refractory Pancreatic Duct Strictures
  • Painful Chronic Pancreatitis
Interventions
  • Device: WallFlex Pancreatic Stent
Sponsor
Boston Scientific Corporation
Start date
2014-06
Primary completion
2015-06
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Belgium
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02135809