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Effectiveness of Metal Clips Prevent Biliary Fully Covered Self-Expandable Metal Stents Migration: a Randomized Controlled Trial

Effectiveness of Metal Clips Prevent Biliary Fully Covered Self-Expandable Metal Stents Migration: a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053429
Enrollment
Unknown
Registered
2021-11-21
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-09-26

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

Conditions

Biliary stricture

Interventions

intervention group:Hemostatic clips secure the biliary fully covered self-expandable metal stent
control group:the biliary fully covered self-expandable metal stent without any fixation.

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Adult patients; 2. Patients are diagnosed with a benign stenosis of the lower segment of the common bile duct (>=2cm from Hepatic hilum) by CT or MRCP. Patients are diagnosed with a malignant stenosis of the lower segment of the common bile duct (>=2cm from Hepatic hilum) by CT or MRCP, with an anticipated survival time of over 6 months, and without the opportunity of surgery when diagnosed.

Exclusion criteria

Exclusion criteria: 1. The patient has contraindications to endoscopy and ERCP; 2. Pregnant or lactating women; 3. CT or MRCP imaging confirmed the existence of hilar bile duct stricture; 4. Drug-induced, hemolytic, hepatocellular jaundice.

Design outcomes

Primary

MeasureTime frame
The rate of stent migration at 3 months and 6 months after stent placement.;

Secondary

MeasureTime frame
Successful fixed rate of hemostatic clips;Duration of stent patency after stent placement;Stent patency rates after stent placement;The rate of complications occurred ;

Countries

China

Contacts

Public ContactDong Jinpei

Peking University First Hospital

917364326@qq.com+86 13651284107

Outcome results

None listed

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