NCT06754397

Brief Summary

Evaluate the diagnostic accuracy of Magnetic Resonance Cholangiopancreatography (MRCP) compared with Ultrasound and Computed Tomography (CT) in patients with obstructive jaundice taking findings of ERCP/ PTC and histopathology as gold standard.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

December 22, 2024

Last Update Submit

December 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of Magnetic Resonance Cholangiopancreatography in patients with obstructive jaundice according to the findings

    Magnetic Resonance Cholangiopancreatography findings in patients with obstructive jaundice comparing to findings of ERCP/ PTC and histopathology .

    Within twelve months

Study Arms (1)

Patients diagnosed with obstructive jaundice

MRCP as a role that is used as a non-invasive diagnostic tool for visualizing the pancreaticobiliary tree without the use of contrast media

Diagnostic Test: Magnetic Resonance Cholangiopancreatography

Interventions

Three most important sequences included axial T2 weighted scan from liver to ampullary region followed by T2 weighted 3D FSE sequence acquired in coronal oblique plane using respiratory triggering by tying bellows over abdomen. After this breath hold HASTE sequence is acquired in coronal plane. Maximum intensity projection (MIP) and thick slab images are also used for interpretation. US, CECT and MRCP scans are interpreted by radiologists blinded to other imaging findings

Also known as: Ultrasound, Computed tomography
Patients diagnosed with obstructive jaundice

Eligibility Criteria

Age15 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.

You may qualify if:

  • Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.

You may not qualify if:

  • Patients with non-obstructive (prehepatic/hepatic) cause of jaundice. Patients having contraindications to perform MRI (Patients with any electrically, magnetically or mechanically activated implants, pacemaker, cochlear implants or any metallic orthopedic implants and claustrophobic patients).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Jaundice, Obstructive

Interventions

Cholangiopancreatography, Magnetic ResonanceUltrasonographyTomography, X-Ray Computed

Condition Hierarchy (Ancestors)

JaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemImage Interpretation, Computer-AssistedRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-Ray

Study Officials

  • Magdy M Amin, Professor

    Medical research ethics committee - Sohag university

    STUDY DIRECTOR

Central Study Contacts

Demiana M Soliman, Resident

CONTACT

Hisham A Amin, A. professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiological resident

Study Record Dates

First Submitted

December 22, 2024

First Posted

December 31, 2024

Study Start

January 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 31, 2024

Record last verified: 2024-12