PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

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

Treatment groups

220 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators