Actively Recruiting
Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis
Led by Changhai Hospital · Updated on 2025-05-18
134
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the efficacy and safety of a single plastic stent versus a fully covered self-expanded metal stent in relieving benign biliary stricture secondary to chronic pancreatitis. The main questions it aims to answer is: Whether the efficacy of a single plastic stent is non-inferior to that of a fully covered metal stent in patients with benign biliary stricture secondary to chronic pancreatitis？ Participants will be randomly assigned to receive either a single plastic stent (SPS) placement or fully covered self-expanded metal stent placement treatment for 6 months, and they will be followed up for 18 months.
CONDITIONS
Official Title
Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Diagnosis of chronic pancreatitis
- Symptomatic biliary stricture with cholangitis or increased bilirubin/alkaline phosphatase for over 4 weeks
- Confirmation of bile duct stricture by imaging
You will not qualify if you...
- Prior plastic stenting longer than six months or any metal stenting
- Incomplete removal of stones from the main pancreatic duct during ERCP
- Biliary stricture caused by conditions other than chronic pancreatitis
- Obstructive biliary symptoms due to acute pancreatitis attack
- Stricture within 2 cm of the common bile duct bifurcation
- Malignant biliary stricture
- Acute or chronic hepatitis, cirrhosis, primary sclerosing cholangitis, congenital biliary malformations, or biliary fistula
- Symptomatic duodenal stenosis with gastric stasis
- Contraindications to endoscopic techniques
- Pregnancy or incarceration
- Life expectancy less than 1 year
- Other conditions making participation inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital Clinical Research Ward
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
L
Lianghao Hu, M.D.
CONTACT
Z
Zhaoshen Li, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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