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RECRUITING
NCT06653192
NA

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

Sponsor: Hospital Universitari de Bellvitge

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-05-06

Completion Date

2028-05-06

Last Updated

2025-07-29

Healthy Volunteers

No

Interventions

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.

Locations (10)

Hospital General Universitario Dr. Balmis

Alicante, Alicante, Spain

Hospital General Universitario de Castellón

Castellon, Castellón, Spain

Hospital de Sant Pau i de la Santa Creu

Barcelona, Catalonia, Spain

Hospital Universitari de Bellvitge

Hospitalet de Llobregat, Barcelona, Catalonia, Spain

Hospital Mútua de Terrassa

Terrassa, Catalonia, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain