Comparing two types of stents for treating bile duct issues from chronic pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of a single plastic stent versus a fully covered self-expanding metal stent in treating benign biliary stricture caused by chronic pancreatitis. Participants will be randomly assigned to receive one of the two stent types, with treatment lasting for six months and follow-up extending to 18 months. The study focuses on whether the single plastic stent can provide similar benefits as the metal stent while potentially being more cost-effective and having fewer complications. The trial is designed as a prospective, open-label, randomized controlled, non-inferiority trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Changhai Hospital Clinical Research Ward
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Liang-Hao Hu, M.D. — Changhai Hospital
• Study coordinator: Lianghao Hu, M.D.
• Email: lianghao-hu@smmu.edu.cn
• Phone: +86-13817593520

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.