Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2025-12-16 @ 8:16 PM
Study NCT ID:
NCT04801160
Status:
None
Last Update Posted:
2023-12-18 00:00:00
First Post:
2021-03-15 00:00:00
Brief Title:
REMS Combined With TAI for Unresectable HC
Sponsor:
Zhongda Hospital
Organization:
Zhongda Hospital
Study Overview
Official Title:
Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) Versus Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
Status:
None
Status Verified Date:
2023-12
Last Known Status:
None
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:
This is a multicentric, open-labal, randomized controlled trial which aims to evaluate the efficacy and safety of Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) versus Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma. The primary hypotheses are that Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) is superior to Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) with respect to Over survival(OS). The primary endpoint is overall survival. The secondary endpoints include quality of life, progression free survival, relief of jaundice, patency, and adverse events.
Detailed Description:
This is a multicentric open-labal randomized controlled trial which aims to evaluate the efficacy and safety of Radiation-Emitting Metallic Stents REMS combined with Trans-Arterial Infusion TAI versus Uncovered Self-Expandable Metallic Stent SEMS Combined With Trans-Arterial Infusion TAI for Unresectable Hilar Cholangiocarcinoma The primary hypotheses are that Radiation-Emitting Metallic Stents REMS combined with Trans-Arterial Infusion TAI is superior to Uncovered Self-Expandable Metallic Stent SEMS Combined With Trans-Arterial Infusion TAI with respect to Over survivalOS The primary endpoint is overall survival The secondary endpoints include quality of life progression free survival relief of jaundice patency and adverse events
Study Oversight
Has Oversight DMC:
None
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?:
None