Comparison of WallFlex Biliary Fully Covered metal stents to plastic stents in patients with Chronic Pancreatitis
- Registration Number
- CTRI/2012/11/003103
- Lead Sponsor
- Boston Scientific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Chronic pancreatitis
Stricture not previously dilated
Symptomatic bile duct stricture
Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
Stricture within 2 cm of the upper esophageal sphincter.
Dysphagia related to motility disorder.
Non-anastomotic esophageal strictures.
Esophagocolonic strictures.
Planned adjuvant radiation therapy post esophagectomy.
Prior esophageal stent placements post esophagectomy.
Active erosive esophagitis.
Sensitivity to any components of the stent or delivery system.
Concurrent medical condition that would affect the investigatorâ??s ability to evaluate the patientâ??s condition or could compromise patient safety.
Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
Stricture length 5 cm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stricture resolution at 24 monthsTimepoint: 24 months following initial study treatment
- Secondary Outcome Measures
Name Time Method Occurence of adverse events <br/ ><br>Number of ERCP procedures <br/ ><br>Ability to deploy stent <br/ ><br>Ability to remove stent <br/ ><br>Liver Function Test <br/ ><br>Number of outpatient procedures <br/ ><br>Number of hospitalizations <br/ ><br>Duration of hospitalizations <br/ ><br>Length of procedure <br/ ><br>Number of devicesTimepoint: 24 months following initial study treatment