RecruitingNot ApplicableNCT06653192

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)

Sponsor

Hospital Universitari de Bellvitge

Enrollment

120 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Biliary Tract Neoplasms Malignant Biliary Obstruction

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria11

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.

Interventions

PROCEDUREEndoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

DEVICESelf-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.

DEVICELumen-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.