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

Zagazig University

Status: Completed

Conditions: Malignant Biliary Obstruction

Treatments: Device: group 1; Device: group 3; Device: group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05786326

ZU-IRB #10426/1-3-2023

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 3 patient groups

multiholes fully covered metaalic stents group

Experimental group

Description:

Insertion of multiholes fully covered self-expandable metallic stents in the biliary tree through Endoscopic retrogrades cholangiopancreatography (ERCP)patients with malignant biliary obstruction.

Treatment:

Device: group 1

parially covered metallic stents group

Active Comparator group

Description:

Insertion of partially covered metallic stents in patients with malignant biliary obstruction.

Treatment:

Device: group 2

unocoered metaalic stents group

Active Comparator group

Description:

Insertion of uncovered metallic stents in patients with malignant biliary obstruction.

Treatment:

Device: group 3