Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-06 @ 5:29 PM
Study NCT ID:
NCT06671418
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-04
First Post:
2024-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction
Sponsor:
Erasmus Medical Center
Organization:
Study Overview
Official Title:
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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:
TESLA RCT
Brief Summary:
The goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (PPS) in patients with malignant hilar biliary obstruction (MHBO). The main question it aims to answer is:
To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection.
Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur.
Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.
To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection.
Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur.
Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: