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EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
Sponsor: Hospital Universitari de Bellvitge
Summary
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.
Official title: Multicenter Study of EUS-guided Gallbladder Drainage vs Choledochoduodenostomy as First Line in Malignant Distal Obstruction in Palliative Patients (CARPEGIEM Trial): an Open-label, Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2024-10-18
Completion Date
2027-10
Last Updated
2025-07-29
Healthy Volunteers
No
Interventions
Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
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, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader. * DPPS size: 7Fr x 3-5-7cm.
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 Universitari de Bellvitge
L'Hospitalet de Llobregat, BARCELONA, Spain
Hospital General Alicante
Alicante, Valencia, Spain
Hospital Universitari de Castello
Castellon, Valencia, Spain
Hospital Santa Creu I Sant Pau
Barcelona, Spain
Hospital Virgen de Las Nieves
Granada, Spain
Complejo Hospitalario de Pamplona
Pamplona, Spain
Hospital Santiago de Compostela
Santiago de Compostela, Spain
Hospital Mutua de Terrassa
Terrassa, Spain
Hospital Clinic de Valencia
Valencia, Spain
Hospital Cunqueiro de Vigo
Vigo, Spain