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Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis

RecruitingNAAges 18 Years - anyAllChanghai Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • endoscopic retrograde biliary drainage (single plastic stent)
  • endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)
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Where

1 site
Shanghai Changhai Hospital Clinical Research Ward
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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