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

January 22, 2024 updated by: H Abdelkader, Zagazig University

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia Governorate
      • Zagazig, Sharkia Governorate, Egypt, 44519
        • Recruiting
        • Zagazig University
        • Contact:
        • Principal Investigator:
          • Aya Elsawy
        • Principal Investigator:
          • Mohamed Magdy
        • Contact:
        • Principal Investigator:
          • Abeer H Abdelkader

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: multiholes fully covered metaalic stents group
Insertion of multiholes fully covered self-expandable metallic stents in the biliary tree through Endoscopic retrogrades cholangiopancreatography (ERCP)patients with malignant biliary obstruction.
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
Other Names:
  • multiholes fully covered metallic stent
Active Comparator: parially covered metallic stents group
Insertion of partially covered metallic stents in patients with malignant biliary obstruction.
Device: 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.
Other Names:
  • partially covered metallic stents
Active Comparator: unocoered metaalic stents group
Insertion of uncovered metallic stents in patients with malignant biliary obstruction.
Device: 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.
Other Names:
  • uncovered metallic stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 3 and 6 months follow up after stents ineration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent dysfunction (obstruction or migration)
Time Frame: after 3 and 6 months from stents insertion
detect the stents dysfunction either obstruction or migration by clinical examination and abdominal ultrasound
after 3 and 6 months from stents insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Director: Mohamed I Magdy, profeesor, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ZU-IRB #10426/1-3-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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