Viewing Study NCT03857958


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Study NCT ID: NCT03857958
Status: UNKNOWN
Last Update Posted: 2019-04-04
First Post: 2019-02-27
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction
Sponsor: Seoul National University Hospital
Organization:

Study Overview

Official Title: Comparison of Metal Versus Plastic Side-by-side Stent Insertion in Malignant Hilar Biliary Obstruction
Status: UNKNOWN
Status Verified Date: 2019-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.
Detailed Description: In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: