NCT06375954

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (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 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.

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: 2024-05-01
• Primary completion: 2026-06-01
• Completion: 2027-05-01
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study