RecruitingNot ApplicableNCT06653192

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)


Sponsor

Hospital Universitari de Bellvitge

Enrollment

120 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called CARPEDIEM) is comparing two ways to drain a blocked bile duct in patients with cancer causing an obstruction near the bottom of the bile duct. The two approaches are: an endoscopic ultrasound-guided procedure (EUS-CD) that creates a shortcut from the bile duct directly into the small intestine, versus the traditional scope-based drainage method (ERCP). **You may be eligible if...** - You have a malignant (cancer-related) blockage of the lower bile duct - Your cancer is considered resectable or potentially resectable (surgery may still be possible) - You have signs of bile duct blockage such as elevated liver enzymes or jaundice - You need bile duct drainage before possible surgery **You may NOT be eligible if...** - Your cancer has already been deemed completely inoperable - You have had a previous bile duct drainage procedure for this condition - You have anatomy or conditions that make either procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

DEVICESelf-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.

DEVICELumen-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

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NCT06653192


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