PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial
NCT Number: NCT06550973
Acronym: PROMETHEUS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Malignant Biliary Obstruction
Interventions: PROCEDURE: pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique
Sponsor: Istituto Clinico Humanitas
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-09-30

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.

Primary Outcome Measures: 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, 0 to 3 months
Secondary Outcome Measures: 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, 0 to 3 months|Rate of technical success, Defined as the rate of successful stent placement in the desired duct at the initial procedure), 0 to 3 months|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, 0 to 3 months|Time needed for technical success, duration of a successful procedure, during procedure|Rate of reintervention, in the 3 months following the procedure, will evaluate the patients who need a reintervention, 0-3 months|Rate of cross-over, Defined as in case of failure of the procedure established by the randomization the rate of crossover to the other procedure done., 0-3 months