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EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

Pancreatic Cancer Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06375954
Study type Interventional
Source Hospital Universitari de Bellvitge
Contact Maria Puigcerver-Mas, MD,
Phone +34 687332007
Email mariapuigcervermas@gmail.com
Status Not yet recruiting
Phase N/A
Start date May 1, 2024
Completion date May 1, 2027
View Details
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