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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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 groups

220 Participants
are divided into 2 treatment groups
Group A: EUS-guided biliary drainageNo intervention 0 interventions
Group B: Rescue techniquesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
0 to 3 months

Secondary outcomes

1

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

Time frame
0 to 3 months
2

Rate of technical success

Defined as the rate of successful stent placement in the desired duct at the initial procedure)

Time frame
0 to 3 months
3

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 frame
0 to 3 months
4

Time needed for technical success

duration of a successful procedure

Time frame
during procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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