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

Istituto Clinico Humanitas

Status: Not yet enrolling

Conditions: Malignant Biliary Obstruction

Treatments: Procedure: pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06550973

4113

Details and patient eligibility

About

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.

Full description

Rationale of the study Patients with distal malignant biliary obstruction have a higher risk of ERCP failure, related to the difficulty of bile duct cannulation. These patients after standard ERCP strategies failure, undergo advanced ERCP rescue strategies and in case of failure to EUS guided biliary drainage. HoweverEUS guided biliary drainage performed following the attempted advanced ERCP strategies, it may carry the risk of adverse events of advance ERCP strategies. We hypothesize that, in this setting of patients, early EUS guided biliary drainage in case of difficult biliary cannulation has a lower risk of post-procedural adverse events, as well as better overall safety and efficacy profiles. This could imply better outcomes such as for those patients who are planned to receive a chemotherapy before surgery in which a complication, such as acute pancreatitis, could delay the treatment.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Agree to receive follow up phone calls
• Able to provide written informed consent

Exclusion criteria

• 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
• Inability to sign the informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

EUS-guided biliary drainage

No Intervention group

Description:

EUS-guided biliary drainage will be performed using a bi-flanged lumen apposing metal stent (LAMS) mounted on an electrocautery-enhanced delivery. After EUS identification of the dilated CBD, a place without interposing vessels will be found by the endosonographer. Transduodenal puncture of the CBD will be performed directly with the LAMS that will be used to cautery the tract and enter the CBD. The diameter and length of the stent and the modality of placing the stent (under complete EUS view or with endoscopic or fluoroscopic guidance) will be chosen at the discretion of the endoscopist performing the procedure.

Rescue techniques

Experimental group

Description:

Rescue 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:

Procedure: pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique