Ireland
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Starting soon Not applicable

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

NCT06375954 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-05-01
Last updated
2024-04-19

Condition(s) studied

Malignant Biliary ObstructionPancreatic CancerBiliary Tract Neoplasms

Investigational drug(s) / intervention(s)

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

Endoscopic biliary drainage: Decompression of the bile duct by endoscopic aproach.

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.

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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.

Primary outcome measure(s)

  • Delay in days between endoscopic biliary drainage and chemotherapy treatment start — 1 day to 12 months
    Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06375954 on ClinicalTrials.gov ↗ ← All trials in Spain