Biliary drainage using a fully covered self-expandable metal stent in patients with malignant distal bile duct obstruction

Biliary drainage using a newly designed fully covered self-expandable metal stent in patients with malignant distal bile duct obstruction: A prospective multicenter feasibility study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007263

Enrollment

Registered

2022-05-09

Start date

2022-04-12

Completion date

Unknown

Last updated

2022-05-30

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, Procedure/Surgery : 1. The procedure is performed under fluoroscopic endoscopic guidance, and the exact location and length of the biliary stricture are determined in advance. 2. A gui

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Anyone who meets all of the following criteria can enroll this study. 1. Adults over 19 years old. 2. unresectable distal biliary malignancy which was radiologically or pathologically diagnosed 3. Expected life expectancy > 3 months based on Karnofsky performance score 4. Patients with informed consent

Exclusion criteria

Exclusion criteria: 1. Surgically altered anatomy except cholecystectomy 2. History of prior biliary metal stenting 3. Coagulopathy (International normalized ratio >1.5, platelet count <50,000) 4. Unsuitable for ERCP 5. Duodenal stricture

Design outcomes

Primary

Measure	Time frame
cumulative stent patency rate	—

Secondary

Measure	Time frame
Overall patient survival;overall patient survival rate without stent dysfunction;Functional success rate	—

Countries

Korea, Republic of

Contacts

Public ContactMin Jae Yang

Ajou University Hospital

creator1999@hanmail.net+82-31-219-7821

Outcome results