Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flared end FCSEMS | Active Comparator | Flared end FCSEMS will be inserted for the benign bile duct stricture. |
|
| Anchoring FCSEMS | Active Comparator | Anchoring FCSEMS will be inserted for benign bile duct stricture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bona stent® (Flared end FCSEMS) | Device | Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stent migration rate | one year |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Do Hyun Park, MD, PhD | Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21184871 | Derived | Park DH, Lee SS, Lee TH, Ryu CH, Kim HJ, Seo DW, Park SH, Lee SK, Kim MH, Kim SJ. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc. 2011 Jan;73(1):64-70. doi: 10.1016/j.gie.2010.09.039. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hanarostent® (Anchoring FCSEMS) | Device | Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP. |
|
|
| Removability | one year |