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RECRUITING
NCT06375967
NA

EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

Sponsor: Hospital Universitari de Bellvitge

View on ClinicalTrials.gov

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

PROCEDURE

Endoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

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, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader. * DPPS size: 7Fr x 3-5-7cm.

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 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