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

NCT06550973 | Not Yet Recruiting DMC

• 1 other identifier: 4113
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Biliary Obstruction

Outcome Measures

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

  0 to 3 months

Secondary Outcomes (6)

• Rate of any of the specific adverse events

  0 to 3 months

• Rate of technical success

  0 to 3 months

• Rate of clinical success

  0 to 3 months

• Time needed for technical success

  during procedure

• Rate of reintervention

  0-3 months

Study Arms (2)

EUS-guided biliary drainage

NO INTERVENTION

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

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.

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

Interventions

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

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.

Rescue techniques

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Alessandro Repici, Prof.,MD

CONTACT

0282247493; alessandro.repici@hunimed.eu

Marco Spadaccini, PhD,MD

CONTACT

0282247097; marco.spadaccini@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08