Clinical trial NCT06550973: PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial
Official title: Randomized, Multicentric Trial, PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Biliary Obstruction
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of AE
timeFrame: 0 to 3 months
Secondary outcomes:
measure: Rate of any of the specific adverse events
timeFrame: 0 to 3 months
measure: Rate of technical success
timeFrame: 0 to 3 months
measure: Rate of clinical success
timeFrame: 0 to 3 months
measure: Time needed for technical success
timeFrame: during procedure
measure: Rate of reintervention
timeFrame: 0-3 months
measure: Rate of cross-over
timeFrame: 0-3 months
Other outcomes:
Locations:
Study officials:
References: