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

Efficacy and Safety of Single Plastic Stent Compared With Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Single Center，Prospective，Non-inferiority, Open Label, Randomized, Controlled Trial

This study is testing whether a plastic stent works just as well as a metal stent for treating bile duct problems caused by chronic pancreatitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06655051 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older diagnosed with chronic pancreatitis and experiencing symptomatic biliary stricture.

Not a fit: Patients with prior plastic stenting exceeding six months, any metal stenting, or biliary stricture of malignant etiology may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and cost-efficient treatment option for patients with benign biliary stricture due to chronic pancreatitis.

How similar studies have performed: Previous studies have indicated limitations in the effectiveness of single plastic stents, but this trial's approach of managing chronic pancreatitis effectively before stent placement is novel and may yield different results.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• 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.

Conditions Chronic Pancreatitis; Benign Biliary Stricture; chronic pancreatitis; benign biliary stricture; ERCP; ERBD; stent