Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01543256
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Chronic pancreatitis
* Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had one prior plastic stent inserted.12
* Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
Exclusion Criteria:
* Biliary stricture of benign etiology other than chronic pancreatitis
* Prior biliary metal stent or any plastic stenting other than one plastic stent of 10 Fr or less for 6 months or fewer
* Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
* Biliary stricture of malignant etiology
* Stricture within 2 cm of common bile duct bifurcation
* Known bile duct fistula or leak
* Subjects for whom endoscopic techniques are contraindicated
* Known sensitivity to any components of the stent or delivery system
* Symptomatic duodenal stenosis (with gastric stasis)
* Participation in another investigational study within 90 days prior to consent
* Investigator Discretion
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01543256
Study Brief:
Protocol Section:
NCT01543256