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A comparison of a fully covered self-expandable metal stent with an external anchoring plastic stent and uncovered stent

A comparison of a fully covered self-expandable metal stent with an external anchoring plastic stent and uncovered stent: Prospective Randomized Multicenter Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005961
Enrollment
108
Registered
2021-03-05
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

None listed

Interventions

Medical Device : In patients with malignant distal biliary duct obstruction, stent patency is compared by inserting a stent as follows. Test group : a plastic stent inserted side-by-side with full cov

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Adults over 19 years of age, voluntarily consenting to clinical trials and signing written consent - Patients of unresectable malignant extrahepatic biliary obstruction

Exclusion criteria

Exclusion criteria: - Patients who have previously undergone surgical biliary drainage - Patients who need continuous percutaneous transcutaneous biliary drainage (PTBD) - Patients who had previously undergone self-expanding metal stent implantation - Patients with malignant stenosis of intrahepatic bile duct or patients with malignant stenosis within 2 cm of the hilum - Patients with an expected life expectancy of 3 months or less - Pregnant patient - Patients who cannot undergo endoscopy at the discretion of the researcher

Design outcomes

Primary

MeasureTime frame
Duration of stent patency

Secondary

MeasureTime frame
During follow-up period, patency rate, occlusion rate, migration rate, rate and frequency of reoperation, rate, cause, severity of adverse reaction, overall survival rate

Countries

Korea, Republic of

Contacts

Public ContactSang Hyub Lee

Seoul National University Hospital

Outcome results

None listed

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