Diffusion-weighted MRI with MRCP to detect tumor-related biliary blockages
The Role of Non-invasive Diffusion-weighted Imaging With MRCP in the Diagnosis of Neoplastic Biliary Obstruction
This study will try diffusion-weighted MRI with MRCP to see if it can tell tumor-related biliary blockages from benign causes in adults with suspected biliary obstruction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The General Authority for Teaching Hospitals and Institutes Research network |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07108725 on ClinicalTrials.gov |
What this trial studies
This observational study uses diffusion-weighted magnetic resonance imaging (DW-MRI) combined with MRCP as a non-invasive approach to differentiate malignant from benign biliary obstructions. Adults with clinically suspected biliary obstruction who are scheduled for MRCP and subsequent ERCP or biopsy will undergo DW-MRI and review of prior ultrasound or CT. Diagnostic performance of DW-MRI will be compared to the gold standards of ERCP findings and histopathology, with follow-up verification when available. Results will be analyzed to report sensitivity, specificity, and overall accuracy for detecting neoplastic biliary obstruction.
Who should consider this trial
Good fit: Adults (≥18) with suspected biliary obstruction who are scheduled for MRCP and planned to undergo ERCP or biopsy and who have had prior ultrasound or CT.
Not a fit: Patients with MRI contraindications, prior major biliary surgery or stent placement, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could allow faster, non-invasive diagnosis and reduce the need for some invasive ERCP procedures or biopsies.
How similar studies have performed: Previous studies have shown promising but not definitive results for DW-MRI in distinguishing malignant from benign biliary strictures, so additional confirmation against ERCP and histology is warranted.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years) with clinically suspected biliary obstruction (e.g., jaundice, elevated liver enzymes, cholestasis). * Patients who are scheduled for magnetic resonance cholangiopancreatography (MRCP) and have undergone conventional imaging \[ultrasound or computed tomography (CT)\]. * Patients who will undergo further invasive procedures, e.g., endoscopic retrograde cholangiopancreatography (ERCP), biopsy. Exclusion Criteria: * Patients with contraindications to magnetic resonance imaging (MRI) (e.g., pacemakers, metal implants). * Patients who have previously undergone major biliary surgery or stent placement. * Pregnant or lactating women.
Where this trial is running
Cairo
- General Authority for Teaching Hospitals and Institutes — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Hekmat S Baumey, MD
- Email: hekmattsamir@gmail.com
- Phone: 00201555433546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.