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
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