Efficacy of the 6-mm fully covered metal stents forpatients with malignant hilar biliary obstruction

Efficacy of the 6-mm fully covered metal stents for endoscopic bilateral side-by-side stent placement in patients with malignant hilar biliary obstruction: a multicenter prospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003755

Enrollment

Registered

2019-04-12

Start date

2019-04-22

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 : Following the placement of two guidewires into the targeted bilateral intrahepatic branches across the hilar stricture, the first 6-mm fully covered stent is then inserted into either

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 20 years of age 2. malignant hilar biliary obstruction of Bismuth type II or higher, causing jaundice 3. cholangiocarcinoma or gallbladder cancer or metastatic cancer 4. unsuitable for curative resection due to locally advanced stage, metastasis, or high surgical risk 5. life expectancy > 4 months

Exclusion criteria

Exclusion criteria: 1. hepatocellular carcinoma 2. surgically altered upper gastrointestinal anatomy following hepatobiliary or gastric surgery except cholecystectomy 3. uncontrolled coagulopathy (International normalized ratio > 1.5 or platelet count < 50,000 /mm3) 4. liver atrophy

Design outcomes

Primary

Measure	Time frame
Stent dysfunction rate	—

Secondary

Measure	Time frame
early advere event;late adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactMin Jae Yang

Ajou University Hospital

creator1999@hanmail.net+82-31-219-6939

Outcome results