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Completed

NCT Number: NCT05786326

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University

Zagazig, Sharkia Governorate, 44519, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group 1

Device

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

Group 2

Device

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

Group 3

Device

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2023
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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