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A Comparative Study on the Efficacy of Novel Antimicrobial-CoatedStents and Traditional Plastic Stents in the Management of MalignantDistal Biliary Stricture: A Single-Center Randomized Trial

A Comparative Study on the Efficacy of Novel Antimicrobial-CoatedStents and Traditional Plastic Stents in the Management of MalignantDistal Biliary Stricture: A Single-Center Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107680
Enrollment
Unknown
Registered
2025-08-18
Start date
2025-08-18
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

maglinant biliary stricture

Interventions

Intervention group:A new antibacterial coated bile duct stent was inserted
Control group:Place a traditional plastic bracket

Sponsors

Department of Gastroenterology, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Laboratory examination, imaging examination and pathological diagnosis are clear as malignant distal bile duct stenosis; 2. Unable or refusal to undergo surgical procedures, and can tolerate ERCP treatment as assessed by anesthesiologists and endoscopists; 3. Age: 18-80 years old; 4. Patients and their families are able to understand the study protocol and voluntarily participate in this study, and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient's basic condition is poor and cannot tolerate ERCP surgery; 2. Special populations: children, pregnant or lactating women, patients with mental illness; 3. The investigator thinks that it is not suitable for selection; 4. Has previously received percutaneous transhepatic biliary drainage or ERCP-guided bile duct stent drainage; 5. Life expectancy less than 6 months.

Design outcomes

Primary

MeasureTime frame
Stent patency duration;

Secondary

MeasureTime frame
Clinical success rate;Unplanned endoscopic re-intervention rate;Stent occlusion rate;Time to unplanned re-intervention;Stent migration rate;Post-ERCP complication rate;

Countries

China

Contacts

Public ContactYaqi Zhai

Chinese PLA General Hospital

astaring@163.com+86 135 0123 3558

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026