Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

Study Overview
=================
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.

Official Title
-----------------
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study

Conditions
-----------------
Bile Duct Disease

Intervention / Treatment
-----------------
* Device: Bona stent® (Flared end FCSEMS)
* Device: Hanarostent® (Anchoring FCSEMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flared end FCSEMS<br>Flared end FCSEMS will be inserted for the benign bile duct stricture. | Device: Bona stent® (Flared end FCSEMS)<br>* Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.<br>* Other names: Bona stent® (Sewoon medical Co., LTD., Seoul, Korea);|
| Active Comparator: Anchoring FCSEMS<br>Anchoring FCSEMS will be inserted for benign bile duct stricture | Device: Hanarostent® (Anchoring FCSEMS)<br>* Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.<br>* Other names: Hanarostent® (M.I.Tech, Seoul, Korea);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent migration rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metal stent, Bile duct stricture, Stent migration, Feasibility, Safety, Removability