Non-invasive Diffusion-weighted Imaging With MRCP in the Diagnosis of Neoplastic Biliary Obstruction

NCT07108725 | Recruiting

• 1 other identifier: HMH00013
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the diagnostic value of non-invasive diffusion-weighted magnetic resonance imaging (DW-MRI) in detecting neoplastic biliary obstruction.

Conditions

Non-invasive Diffusion-weighted Imaging; Magnetic Resonance Cholangiopancreatography; Diagnosis; Neoplastic Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

• Sensitivity of magnetic resonance cholangiopancreatography

  Sensitivity of magnetic resonance cholangiopancreatography to predict of a tumor will be recorded.

  Immediately after magnetic resonance cholangiopancreatography (Up to 1 hour)

Study Arms (1)

Study group

Patients who are scheduled for magnetic resonance cholangiopancreatography and have undergone conventional imaging

Other: Magnetic Resonance Cholangiopancreatography

Interventions

Magnetic Resonance Cholangiopancreatography OTHER

Patients who are scheduled for magnetic resonance cholangiopancreatography and have undergone conventional imaging

Study group

Eligibility Criteria

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

Study Population

This is a prospective, observational, diagnostic accuracy study. The study will include patients with suspected biliary obstruction, referred to our hospital for diagnostic imaging.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The General Authority for Teaching Hospitals and Institutes: lead

Study Sites (1)

General Authority for Teaching Hospitals and Institutes

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hekmat S Baumey, MD

CONTACT

00201555433546; hekmattsamir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Diagnostic Radiology, Damnhour National Medical Institute

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)