About this trial
Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction. A premise element in achieving success during therapeutic ERCP is selective biliary cannulation (SBC). Nevertheless, SBC doesn't consistently yield favorable outcomes, even among expert endoscopists, failing in around 25% to 50% of cases with standard ERCP approach (sphincterotome and guidewire).
In such situations, depending on the endoscopist's experience and preference, various advanced techniques come into play. These encompass the double guidewire cannulation approach, needle-knife precut papillotomy or fistulotomy, and transpancreatic sphincterotomy, serving as potential rescue methods.
In recent times, the EUS-guided approach has been gaining increasing significance. Initially, it was viewed as a rescue option in cases where advanced ERCP techniques failed (5-15% of cases). More recently, it has proved its feasibility as a first line alternative to ERCP in scenarios involving malignant biliary obstruction.
Eligibility criteria
Qualifiers
Age ≥18 years
Patients with distal malignant biliary obstruction
Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing a dilated common bile duct > 15 mm diameter.
Difficult biliary cannulation defined as ESGE guidelines
Disqualifiers
Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000 103/mm3.
Use of anticoagulants that cannot be discontinued
Pregnant women
Previous ERCP or EUS-BD attempt
Trial design
Treatments tested in this trial
- pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique