Multihole Fully Covered Metallic Stents in the Management of Malignant Biliary Obstruction

Study Overview
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Brief Summary
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multiholes fully covered metallic stents in the management of malignant biliary obstruction

Detailed Description
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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

Official Title
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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.

Conditions
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Malignant Biliary Obstruction

Intervention / Treatment
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* Device: group 1
* Device: group 2
* Device: group 3


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinical diagnosis of malignant obstructive jaundice. Patient not eligible for surgery. Age above 18 years, any gender. Exclusion criteria: Benign obstructive jaundice. Patient eligible for surgery. Failure to stent insertion. Patient not fit for ERCP and/or anaesthesia. Surgical and anatomical abnormalities interfere with endoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multiholes fully covered metaalic stents group<br>Insertion of multiholes fully covered self-expandable metallic stents in the biliary tree through Endoscopic retrogrades cholangiopancreatography (ERCP)patients with malignant biliary obstruction. | Device: group 1<br>* 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<br>* Other names: multiholes fully covered metallic stent;|
| Active Comparator: parially covered metallic stents group<br>Insertion of partially covered metallic stents in patients with malignant biliary obstruction. | Device: group 2<br>* 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.<br>* Other names: partially covered metallic stents;|
| Active Comparator: unocoered metaalic stents group<br>Insertion of uncovered metallic stents in patients with malignant biliary obstruction. | Device: group 3<br>* 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.<br>* Other names: uncovered metallic stents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |