Safety and efficacy of anti-biofilm and anti-inflammatory covered biliary metal stent

Safety and efficacy of a novel immobilization of silver in silicone membrane-covered metal stent for endoscopic draining a malignant biliary obstruction

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002310

Enrollment

Registered

2017-04-13

Start date

2017-06-08

Completion date

Unknown

Last updated

2019-04-23

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 : To determine safety and efficacy of this novel silver-integrated silicone covered metal stent in patients with malignant distal biliary obstruction, we conducted this pilot study. The

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Only adults over 19 years old 2. A patient required biliary drainage with a malignant biliary obstruction 3. A patient with distal malignant biliary obstruction located below 2 cm lower part to the hepatic hilum. 4. Patients who are unable to perform surgery or who are unable to perform due to systemic or comorbid conditions 5. A person who understands in this clinical trial and agrees to participate and has agreed in writing with the subject or legal representative.

Exclusion criteria

Exclusion criteria: 1. Under 18 years old 2. Patients with suspected benign biliary strictures 3. If the life expectancy is less than 1 month due to multiple systemic metastasis 4. Patients who can not understand or agree with this study 5. Patients with uncontrolled bleeding and bleeding tendencies. 6. Patients who have difficulty in endoscopic procedures due to anatomic deformity by existing surgery.

Design outcomes

Primary

Measure	Time frame
stent patency	—

Secondary

Measure	Time frame
The detection rate of silver ion in serum and urine;stent related adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactJi Seon Lee

Asan Medical Center

jisun-asan@naver.com+82-2-3010-4663

Outcome results