NCT06653192

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

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: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or 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.

Conditions

• Malignant Biliary Obstruction
• Pancreatic Cancer
• Biliary Tract Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Endoscopic biliary drainage	Decompression of the bile duct by endoscopic aproach.
DEVICE	Self-expandable metallic stent (SEMS)	Self-expandable metallic stent (SEMS) deployment: Covering: Uncovered or Partially Covered. Non covered if gallbladder is present. Size: 10x40mm or 10x60mm or 10x80mm.
DEVICE	Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)	Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct \> 18mm. DPPS size: 7Fr x 3-7cm.

Timeline

• Start date: 2025-05-06
• Primary completion: 2027-06-06
• Completion: 2028-05-06
• First posted: 2024-10-22
• Last updated: 2025-07-29

Locations

10 sites across 1 country: Spain

Regulatory

• FDA-regulated device study