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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique
Procedure/SurgeryRescue techniques, such as pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique, wire-guided cannulation over a pancreatic stent and transpancreatic biliary sphincterotomy, will be used at the discretion of the endoscopist \[12\]. After deep cannulation, a cholangiogram to better define the characteristics of the stenosis will be done. The stent will then be inserted over a guidewire and deployed across the stenosis. All stents will be fully covered SEMSs or partially covered SEMSs of 10 mm diameter. The length of the stent will be chosen at the discretion of the endoscopist performing the procedure. A prophylactic pancreatic stent will be placed in patients who will be thought to be at high risk of post-procedure pancreatitis at the discretion of the treating endoscopist.
Treatment groups
Trial outcomes
Primary outcomes
Rate of AE
such as the occurrence of unintentional perforation, bleeding requiring hemostasis, pancreatitis, stent malposition or migration, cholecystitis or cholangitis, jaundice, peritonitis, symptomatic bile leak, subcapsular liver hematoma, pneumoperitoneum, retained sheared wire, and procedure-related death
Secondary outcomes
Rate of any of the specific adverse events
such as the occurrence of unintentional perforation, bleeding requiring hemostasis, pancreatitis, stent malposition or migration, cholecystitis or cholangitis, jaundice, peritonitis, symptomatic bile leak, subcapsular liver hematoma, pneumoperitoneum, retained sheared wire, and procedure-related death
Rate of technical success
Defined as the rate of successful stent placement in the desired duct at the initial procedure)
Rate of clinical success
Defined as decrease of bilirubin level to either half the initial level, or less than 3 dl/mg -in order to allow to start chemotherapy
Time needed for technical success
duration of a successful procedure
Locations
Sponsors and contacts
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