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Clinical Trials/NCT05786326
NCT05786326CompletedNot Applicable

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.

Zagazig University1 site in 1 country50 target enrollmentStarted: March 28, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

multiholes fully covered metaalic stents group

Experimental

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

Intervention: group 1 (Device)

parially covered metallic stents group

Active Comparator

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

Intervention: group 2 (Device)

unocoered metaalic stents group

Active Comparator

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

Intervention: group 3 (Device)

Outcomes

Primary Outcomes

Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction

Time Frame: 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 Outcomes

  • Stent dysfunction (obstruction or migration)(after 3 and 6 months from stents insertion)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

H Abdelkader

lecturer at tropical medicine department, faculty of medicine,Zagazig

Zagazig University

Study Sites (1)

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