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RECRUITINGINTERVENTIONAL

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

Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction: An Open-label, Multicenter Randomized Trial (CARPEDIEM Trial)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE or POTENTIALLY RESECTABLE/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 willing to sign a consent form. - Patient who understands the type of study and will comply with all follow-up tests throughout its duration Who Should NOT Join This Trial: - 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. - Patients with prior biliary stents or other biliary drainages (e.g., PTCD). - Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y). - Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla. - Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture). - Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available. - Patients incapable of maintaining follow-up appointments (lack of adherence). - Lack of willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE or POTENTIALLY RESECTABLE/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 Exclusion Criteria: * 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. * Patients with prior biliary stents or other biliary drainages (e.g., PTCD). * Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y). * Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla. * Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture). * Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available. * Patients incapable of maintaining follow-up appointments (lack of adherence). * Lack of informed consent.

Treatments Being Tested

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.

Locations (10)

Hospital General Universitario Dr. Balmis
Alicante, Alicante, Spain
Hospital General Universitario de Castellón
Castellon, Castellón, Spain
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Catalonia, Spain
Hospital Mútua de Terrassa
Terrassa, Catalonia, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain