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

Not Applicable

Completed

• Conditions: Malignant Biliary Obstruction
• Interventions: Device: group 2; Device: group 1; Device: group 3

• Registration Number: NCT05786326
• Lead Sponsor: Zagazig University

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

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-03-27
• Study Start: 2023-03-28
• Primary Completion: 2024-03-01
• Status Verified: 2024-07
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
parially covered metallic stents group	group 2	Insertion of partially covered metallic stents in patients with malignant biliary obstruction.
multiholes fully covered metaalic stents group	group 1	Insertion of multiholes fully covered self-expandable metallic stents in the biliary tree through Endoscopic retrogrades cholangiopancreatography (ERCP)patients with malignant biliary obstruction.
unocoered metaalic stents group	group 3	Insertion of uncovered metallic stents in patients with malignant biliary obstruction.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Sharkia Governorate, Egypt