Malignant Biliary Obstruction
Conditions
Keywords
Fully Covered Self Expandable Metal Stent, Uncovered Self Expandable Metal Stent
Brief summary
Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction
Detailed description
This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.
Interventions
DEVICEfully covered self-expandable metal stent with an anchoring external plastic stent
Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent
DEVICEuncovered self-expandable metal stent
Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with 19 years of age or older * Those who voluntarily consented to the trial and signed a written consent * Inoperable malignant biliary obstruction
Exclusion criteria
* Previous surgical biliary drainage * Patients continuosly requiring percutaneous transhepatic biliary drainage * History of biliary drainage with metal stent * Biliary obstruction located in hilum or intrahepatic duct * Patients with life expectancy of 3 months or less * On pregnancy * Unable to underwent endoscopic procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patent stent | 1 year | The number of patient without stent dysfuction divided by total number of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent obstruction | 1 year | Suspected by jaundice (Total bilirubin \> 2 upper normal limit) or radiologic finding of stent occlusion which is confirmed by ERCP |
| Stent migration | 1 year | Radiologic finding of migration through Abdomen X-ray or CT scan |
| Re-intervention | 1 year | Endoscopic retrograde biliary drainage or Percutaneous transhepatic biliary drainage |
| Adverse event | 1 year | acute cholangitis, acute cholecystitis, acute pancreatitis |
| Overall survival | 1 year | Timespan from the diagnosis to the death |
Countries
South Korea
Contacts
Primary ContactSang Hyub Lee, MD, PhD
Outcome results
None listed