Bile Duct Disease
Conditions
Keywords
Metal stent, Bile duct stricture, Stent migration, Feasibility, Safety, Removability
Brief summary
The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.
Detailed description
Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.
Interventions
DEVICEBona stent® (Flared end FCSEMS)
Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
DEVICEHanarostent® (Anchoring FCSEMS)
Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient over 18 years old * Patient with benign bile duct stricture
Exclusion criteria
* No written informed consent * Malignant biliary obstruction * Patients with uncorrectable severe coagulopathy * Patients with severe cardiopulmonary disease precluding sedation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent migration rate | one year |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility (Technical success rate and functional success rate) | one year |
| Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure) | one year |
| Removability | one year |
Countries
South Korea
Outcome results
None listed