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multiholes fully covered metallic stents in the management of malignant biliary obstruction
Malignant biliary obstruction is still a diagnostic and therapeutic challenge requiring a multidisciplinary approach. Most cases are inoperable at the time of diagnosis. Relieving the obstruction and normalizing the serum bilirubin level is usually the first step by biliary catheterization and stent placement.
Biliary stent placement has largely replaced surgical bypass for the palliation of malignant biliary obstruction. Rigid plastic stents, despite it is cheap and easily removed, but with limited duration of stent patency. Self-expandable metal stents (SEMS) have larger luminal diameters and provide longer patency time than rigid plastic stents. SEMS are composed of a variety of metals and can be uncovered, partially covered, or fully covered.
Uncovered stents are prone to obstruction by tumor growths; however, covered stents may block bile duct branches and are at risk of migration. A multihole self-expandable metallic stent was developed to prevent the obstruction of bile duct branches. In addition, the holes may prevent migration due to small ingrowths which reduce the tension of the membrane
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multiholes fully covered metaalic stents group | Experimental | Insertion of multiholes fully covered self-expandable metallic stents in the biliary tree through Endoscopic retrogrades cholangiopancreatography (ERCP)patients with malignant biliary obstruction. |
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| parially covered metallic stents group | Active Comparator | Insertion of partially covered metallic stents in patients with malignant biliary obstruction. |
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| unocoered metaalic stents group | Active Comparator | Insertion of uncovered metallic stents in patients with malignant biliary obstruction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group 1 | Device | Insertion of fully covered self-expanding metallic stents with multi-holes (FCSEMS- MH) Biliary stent HANAROSTENT® CCC (M.I.Tech Co., Ltd, pyeongtaek, Korea) in a biliary tree through endoscopic retrograde cholangiopancreatography (ERCP) under general anesthesia by expertise in patients with malignant biliary obstruction |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction | Detect the stent in his place. Patients clinically improved, and bilirubin decrease or reach normal values. | at 3 and 6 months follow up after stents ineration |
| Measure | Description | Time Frame |
|---|---|---|
| Stent dysfunction (obstruction or migration) | detect the stents dysfunction either obstruction or migration by clinical examination and abdominal ultrasound | after 3 and 6 months from stents insertion |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed I Magdy, profeesor | Zagazig University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University | Zagazig | Sharkia Governorate | 44519 | Egypt |
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| group 2 | Device | Insertion of partially covered self-expanding metallic stents HANAROSTENT® Biliary (NCN) in the biliary tree through ERCP under general anesthesia by Expertise in patients with malignant biliary obstruction. |
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| group 3 | Device | Insertion of uncovered self-expanding metallic stents (Biliary stent HANAROSTENT® NNN) (M.I.Tech Co., Ltd. Pyeongtaek, Korea) in a biliary tree through ERCP under general anesthesia by Expertise in patients with malignant biliary obstruction. |
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