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

NCT06550973 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-08-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-09-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06550973 on ClinicalTrials.gov