RecruitingNot ApplicableNCT06375967

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

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

Sponsor

Hospital Universitari de Bellvitge

Enrollment

128 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Neoplasms Pancreatic Cancer Non-resectable Malignant Biliary Obstruction

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two procedures used to drain a blocked bile duct in patients with cancers that have blocked the lower part of the duct (like pancreatic cancer): one uses an ultrasound-guided gallbladder drainage (EUS-GBD) and the other uses a traditional stent placement through a scope (choledocho-duodenostomy, or CDS). **You may be eligible if...** - You have a malignant (cancer-related) blockage of the lower bile duct - Your cancer is being managed with palliative (comfort-focused) care and you need bile drainage - Your case has been reviewed and confirmed by a specialist team - You are able to understand and sign informed consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a severe bleeding disorder - You have had your gallbladder removed or it has been perforated - Cancer is blocking the cystic duct (the tube to the gallbladder) - More than 30% of your liver is affected by metastases 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.

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

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.