Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653192
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction CARPEDIEM Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction An Open-label Multicenter Randomized Trial CARPEDIEM Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to evaluate the biliary drainage technical failure rate andor the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction
Detailed Description:
Ecoendoscopy-guided choledochoduodenostomy EUS-CDS has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction MDBO However there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients showing similar clinical and technical success and adverse events AEs rate between both techniques Data about the benefit of this techique in potentially surgical patients is still limited
Recent retrospective study Janet J et al Ann Surg Oncol 2023 and two recent meta-analysis Barbosa E et al GIE 2024 Gopakumar H et al AM J Gastr 2024 both with 500 cases found that EUS-CDS group had significantly less technical failure rate and less postprocedure pancreatitis rate
Thus our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates technical failure postprocedure pancreatitis when compared to ERCP in MDBO in potentially surgical patients with resectable and borderline disease
Recent retrospective study Janet J et al Ann Surg Oncol 2023 and two recent meta-analysis Barbosa E et al GIE 2024 Gopakumar H et al AM J Gastr 2024 both with 500 cases found that EUS-CDS group had significantly less technical failure rate and less postprocedure pancreatitis rate
Thus our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates technical failure postprocedure pancreatitis when compared to ERCP in MDBO in potentially surgical patients with resectable and borderline disease
Study Oversight
Has Oversight DMC:
None
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?:
None