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EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

NCT06653192 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-06

No results posted yet for this study

Summary

The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction.

Conditions

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 General Universitario de Castellón

    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 · Hospital Universitari de Bellvitge, SEED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2027-06-06
Completion
2028-05-06
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06653192 on ClinicalTrials.gov