EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)
NCT06375928 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2024-04-19
Summary
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.
Conditions
- Malignant Biliary Obstruction
- Pancreatic Cancer Resectable
- Biliary Tract Neoplasms
Interventions
- PROCEDURE
-
Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
- DEVICE
-
Self-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.
- 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 Mutua de Terrassa
collaborator OTHER -
Hospital Clínico Universitario de Valencia
collaborator OTHER -
Hospital General Universitario de Alicante
collaborator OTHER -
Hospital Universitario Ramon y Cajal
collaborator OTHER -
Hospital General Universitario de Castellón
collaborator OTHER -
Hospital Álvaro Cunqueiro
collaborator OTHER -
Complejo Hospitalario Universitario de Santiago
collaborator OTHER -
University Hospital Virgen de las Nieves
collaborator OTHER -
Complejo Hospitalario de Navarra
collaborator OTHER -
Hospital de Sant Pau
collaborator OTHER -
University of Salamanca
collaborator OTHER -
Hospital Universitari de Bellvitge
lead OTHER
Principal Investigators
-
Joan B Gornals, PhD · Bellvitge University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2026-02-01
- Completion
- 2026-05-01
- FDA Device
- Yes
Countries
- Spain
Study Locations
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