Malignant Biliary Obstruction
Conditions
Brief summary
multiholes fully covered metallic stents in the management of malignant biliary obstruction
Detailed description
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
Interventions
DEVICEgroup 1
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
DEVICEgroup 2
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.
DEVICEgroup 3
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.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent dysfunction (obstruction or migration) | after 3 and 6 months from stents insertion | detect the stents dysfunction either obstruction or migration by clinical examination and abdominal ultrasound |
Countries
Egypt
Outcome results
None listed