A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent

NCT05220475 | Unknown

• 1 other identifier: H-2012-043-1179
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

Conditions

Malignant Biliary Obstruction

Keywords

Fully Covered Self Expandable Metal Stent; Uncovered Self Expandable Metal Stent

Outcome Measures

Primary Outcomes (1)

• Rate of patent stent

  The number of patient without stent dysfuction divided by total number of patients

  1 year

Secondary Outcomes (5)

• Stent obstruction

  1 year

• Stent migration

  1 year

• Re-intervention

  1 year

• Adverse event

  1 year

• Overall survival

  1 year

Study Arms (2)

fc-SEMS with anchoring plastic stent

EXPERIMENTAL

fully covered self-expanable metal stent with an external anchoring plastic stent

Device: fully covered self-expandable metal stent with an anchoring external plastic stent

uc-SEMS

ACTIVE COMPARATOR

uncovered self-expandable metal stent

Device: uncovered self-expandable metal stent

Interventions

fully covered self-expandable metal stent with an anchoring external plastic stent DEVICE

Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent

fc-SEMS with anchoring plastic stent

uncovered self-expandable metal stent DEVICE

Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent

uc-SEMS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with 19 years of age or older
• Those who voluntarily consented to the trial and signed a written consent
• Inoperable malignant biliary obstruction

You may not qualify if:

• Previous surgical biliary drainage
• Patients continuosly requiring percutaneous transhepatic biliary drainage
• History of biliary drainage with metal stent
• Biliary obstruction located in hilum or intrahepatic duct
• Patients with life expectancy of 3 months or less
• On pregnancy
• Unable to underwent endoscopic procedures

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Study Officials

• Sang Hyub Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Hyub Lee, MD, PhD

CONTACT

82-2072-2228; gidoctor@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 2, 2022
• Study Start: October 25, 2021
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2024
• Last Updated: February 2, 2022

Record last verified: 2022-01

Locations

KR (1)