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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT06655051
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 or older;
2. Patients diagnosed with CP;
3. Symptomatic biliary stricture documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted: cholangitis, and/or an increase in total bilirubin or alkaline phosphatase levels(\> 2 times the upper limit of normal) for more than 4 weeks;
4. Confirmation of bile duct stricture by imaging assessment.
Exclusion Criteria:
1. Prior plastic stenting exceeding six months or any metal stenting;
2. Incomplete removal of stones from the main pancreatic duct located in the head of the pancreas during ERCP procedures;
3. Biliary stricture of benign etiology other than chronic pancreatitis;
4. Developing obstructive biliary symptoms associated with an attack of acute pancreatitis;
5. Stricture within 2 cm of common bile duct bifurcation;
6. Biliary stricture of malignant etiology;
7. Patients with acute or chronic hepatitis, cirrhosis, primary sclerosing cholangitis, congenital biliary malformations or biliary fistula;
8. Symptomatic duodenal stenosis (with gastric stasis);
9. Subjects for whom endoscopic techniques are contraindicated;
10. Pregnancy, incarceration;
11. Life expectancy \< 1 year;
12. Other conditions that inappropriate to participant in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06655051
Study Brief:
Protocol Section:
NCT06655051