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

NCT05786326 | Completed DMC

• 1 other identifier: ZU-IRB #10426/1-3-2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Stent dysfunction (obstruction or migration)

  after 3 and 6 months from stents insertion

Study Arms (3)

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.

Device: group 1

parially covered metallic stents group

ACTIVE COMPARATOR

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

Device: group 2

unocoered metaalic stents group

ACTIVE COMPARATOR

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

Device: group 3

Interventions

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

Also known as: multiholes fully covered metallic stent

multiholes fully covered metaalic stents group

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.

Also known as: partially covered metallic stents

parially covered metallic stents group

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.

Also known as: uncovered metallic stents

unocoered metaalic stents group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of malignant obstructive jaundice.
• Patient not eligible for surgery.
• Age above 18 years, any gender.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Sharkia Governorate, 44519, Egypt

Location

Study Officials

• Mohamed I Magdy, profeesor

  Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at tropical medicine department, faculty of medicine,Zagazig

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 27, 2023
• Study Start: March 28, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)