Zagazig University
Zagazig, Sharkia Governorate, 44519, Egypt
NCT Number: NCT05786326
multiholes fully covered metallic stents in the management of malignant biliary obstruction
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Zagazig, Sharkia Governorate, 44519, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: multiholes fully covered metallic stent
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.
Other names: partially covered metallic stents
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.
Other names: uncovered metallic stents
Time frame: at 3 and 6 months follow up after stents ineration
Detect the stent in his place. Patients clinically improved, and bilirubin decrease or reach normal values.
Time frame: after 3 and 6 months from stents insertion
detect the stents dysfunction either obstruction or migration by clinical examination and abdominal ultrasound
Zagazig University
Other Gov
The Use of Multi Holes Fully Covered Metallic Stents Versus Uncovered and Partially Covered Metallic Stents in the Management of Malignant Biliary Obstruction: Randomized Parallel Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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