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.
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
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.
Parallel
Endoscopic biliary drainage
Procedure/SurgeryDecompression of the bile duct by endoscopic aproach.
Self-expandable metallic stent (SEMS)
DeviceSelf-expandable metallic stent (SEMS) deployment: * Covering: Uncovered or Partially Covered. Non covered if gallbladder is present. * Size: 10x40mm or 10x60mm or 10x80mm.
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
DeviceLumen-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.
Delay in days between endoscopic biliary drainage and chemotherapy treatment start
Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.
Technical success
ERCP group: cannulation, cholangiogram, correct deployment of SEMS
Clinical success
In jaundice: decreasing \> 50% of bilirrubin or normalization of bilirrubin levels 14 days after endoscopic procedure.
AE - biliary drainage
Adverse events rate related to biliary drainage according to the AGREE classification
AE - surgery
Adverse events rate related to surgery according to the Claiven and Dindo classification.
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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
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