Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375954
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease CARPEDIEM-2 Trial
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Hospital Universitari de Bellvitge
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 in Borderline Disease An Open-label Multicenter Randomized Trial CARPEDIEM-2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
The aim of this clinical trial is to evaluate temporal delay days between biliary drainage EUS-CDS vs ERCP as first line therapy and chemotherapy start in patients with borderline 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 borderline patients is still limited
A recent retrospective study Janet J et al Ann Surg Oncol 2023 which included borderline patients found that EUS-CDS group had significantly less delay days between biliary drainage and neoadjuvant chemotherapy start than the ERCP group with fewer endoscopy and surgery AEs
Thus our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage and neoadjuvant chemotherapy start when compared to ERCP in MDBO in borderline patients
A recent retrospective study Janet J et al Ann Surg Oncol 2023 which included borderline patients found that EUS-CDS group had significantly less delay days between biliary drainage and neoadjuvant chemotherapy start than the ERCP group with fewer endoscopy and surgery AEs
Thus our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage and neoadjuvant chemotherapy start when compared to ERCP in MDBO in borderline patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None