Skip to content

A prospective study for evaluation of efficacy of a 12mm diameter polytetrafluoroethylene partial covered stent in malignant extrahepatic biliary obstruction

A prospective study for evaluation of efficacy of a 12mm diameter polytetrafluoroethylene partial covered stent in malignant extrahepatic biliary obstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005989
Enrollment
161
Registered
2021-03-11
Start date
2021-03-23
Completion date
Unknown
Last updated
2026-03-02

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 : Percutaneous transhepatic biliary drainage (PTBD) is performed prior to stent treatment, and the area to be performed is determined and treated by investigator. Stent implantation is

Sponsors

Asan Medical Center
Lead Sponsor
GangNeung Asan Hospital
Collaborator
Koera University Guro Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult patients aged 19 to under 80 years of age 2) Patients who are closed to malignancy, which is not surgical or resectable 3) Patients with obstructive obstruction caused by lymph node metastasis in the primary carcinoma other than the liver 4) Patients who cannot or fail endoscopic stent implantation 5) Patients who have not previously undergone bile duct surgery 6) Patients with an expected survival rate of at least 2 months (Eastern Cooperative Oncology Group Performance Status [ECOG-PS] less than 3 points)

Exclusion criteria

Exclusion criteria: 1) Patients who had previously undergone endoscopic stent implantation or bile duct surgery 2) Patients with expansion of biliary tract in the liver or external biliary tract in the liver 3) Hemophilia patients 4) Patients with three or more ECOG points

Design outcomes

Primary

MeasureTime frame
Opening rate: Opening rate of 12mm diameter PTFE covered stent for treatment of malignant extrahepatic biliary obstruction.

Secondary

MeasureTime frame
Analysis of complications related to treatment;Analysis of survival rate of patients

Countries

Korea, Republic of

Contacts

Public ContactMINGYU LEE

S&G Biotech

2mingyuuu@naver.com+82-31-748-6625

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 14, 2026