Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-04 @ 4:05 PM
Study NCT ID:
NCT04805450
Status:
UNKNOWN
Last Update Posted:
2023-03-21
First Post:
2015-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Status:
UNKNOWN
Status Verified Date:
2023-03
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:
SEMS
Brief Summary:
Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered \[1\]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents \[2-5\].
The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.
The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: