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

NANot yet recruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Malignant Biliary Obstruction
Interventions
PROCEDURE

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

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.

All Listed Sponsors
lead

Istituto Clinico Humanitas

OTHER

NCT06550973 - PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial | Biotech Hunter | Biotech Hunter