EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge

About this trial

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.

Eligibility criteria

Qualifiers

Malignant distal biliary obstruction diagnosed in patient considered BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.

Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)

Patient capable of understanding and/or singning the informed consent.

Patient who understands the type of study and will comply with all follow-up tests throughout its duration

Disqualifiers

Pregnancy or lactation.

Severe coagulation disorder: INR > 1.5 non correctable with plasma administration and/or platelet count < 50.000/mm3.

Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative

Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.

Trial design

Treatments tested in this trial

  • Endoscopic biliary drainage
  • Self-expandable metallic stent (SEMS)
  • Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital Universitari de Bellvitge

Lead sponsor

Hospital Mutua de Terrassa

Collaborator

Hospital Clínico Universitario de Valencia

Collaborator

Hospital General Universitario de Alicante

Collaborator

Hospital Universitario Ramon y Cajal

Collaborator

Hospital General Universitario de Castellón

Collaborator

Hospital Álvaro Cunqueiro

Collaborator

Complejo Hospitalario Universitario de Santiago

Collaborator

University Hospital Virgen de las Nieves

Collaborator

Complejo Hospitalario de Navarra

Collaborator

Hospital de Sant Pau

Collaborator

University of Salamanca

Collaborator