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

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.

Conditions

• Malignant Biliary Obstruction
• Biliary Tract Neoplasms
• Pancreatic Cancer Non-resectable

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.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valencia

  collaborator OTHER

• Hospital General Universitario de Alicante

  collaborator OTHER

• Hospital Mutua de Terrassa

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital General Universitario de Castellón

  collaborator OTHER

• Complejo Hospitalario de Navarra

  collaborator OTHER

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Hospital de Sant Pau

  collaborator OTHER

• University of Salamanca

  collaborator OTHER

• Complejo Hospitalario Universitario de Santiago

  collaborator OTHER

• Complejo Hospitalario Universitario de Vigo

  collaborator OTHER

• Hospital Universitari de Bellvitge

  lead OTHER

Principal Investigators

• Joan B Gornals Soler · Study Principal Investigator

• Carme Loras · Hospital Universitari Mutua de Terrassa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-18

Primary Completion

2026-10-31

Completion

2027-10-31

FDA Device

Yes

Countries

• Spain

Study Locations