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A pilot study on the safety and usefulness of a newly developed anti-reflux metal stent in patients with early occlusion of metal stents in patients with distal malignant biliary obstruction

A pilot study on the safety and usefulness of a newly developed anti-reflux metal stent in patien ts with early occlusion of metal stents in patients with distal malignant biliary obstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009993
Enrollment
40
Registered
2024-12-04
Start date
2024-12-02
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None listed

Interventions

None listed

Sponsors

Bundang CHA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among patients over 19 years of age with confirmed malignant distal biliary obstruction that cannot be surgically resected, patients who developed early obstruction due to food, biliary sludge, or stones within 3 months after previous metal stent insertion If you agree to participate in this study and voluntarily complete the subject consent form

Exclusion criteria

Exclusion criteria: ? Those who cannot obtain consent ? Those with a life expectancy of less than 3 months ? Those with acute cholecystitis ? When premature stent closure is due to cancer invasion ? Patients with malignant hilar bile duct obstruction ? Pregnant women ? When subjects who do not meet the selection/exclusion criteria participate in the study ? Patients for whom ERCP cannot be performed, such as when duodenoscope access fails or selective bile duct insertion fails. ? Other cases where the researcher determines that it is not appropriate to proceed with the research.

Design outcomes

Primary

MeasureTime frame
Stent patency maintenance period

Secondary

MeasureTime frame
other adverse events

Countries

Korea, Republic of

Contacts

Public Contactsungyong han

Pusan National University Hospital

mirsaint@hanmail.net+82-51-240-7869

Outcome results

None listed

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