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

Malignant Biliary Obstruction Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786326
• Other study ID #: ZU-IRB #10426/1-3-2023
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

multiholes fully covered metallic stents in the management of malignant biliary obstruction

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Biliary Obstruction

Intervention

Device:
• group 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
• group 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.
• group 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.

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig	Sharkia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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