Obstructive JaundiceNCT06754397
Diagnostic Accuracy of Magnetic Resonance Cholangiopancreatography in Patients With Obstructive Jaundice
An observational study of Obstructive Jaundice, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 89 years
- Conditions the study is for
- Obstructive Jaundice
- What is being tested?
- Magnetic Resonance Cholangiopancreatography
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.
Who may be able to join
- Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hisham A Amin, A. professor contact
About this study
Official title: Diagnostic Accuracy of Magnetic Resonance Cholangiopancreatography as Compared to Ultrasound and Computed Tomography in Patients With Obstructive Jaundice
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.
Read the detailed description
MRCP as a diagnostic role to determine the presence and severity of biliary and pancreatic ductal dilatation. It can also detect the length of the stricture as well as the exact cause and location of the obstructing lesion in comparison to other modalities.
- Conditions
- Obstructive Jaundice
- Being tested
- Magnetic Resonance Cholangiopancreatography
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance CholangiopancreatographyDiagnostic test
Also called Ultrasound, Computed tomography
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Magnetic Resonance Cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Within twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demiana Mohsen Soliman, Sohag University
- Investigators
- Magdy M Amin, Professor, Study director, Medical research ethics committee - Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754397
- Sponsor's protocol ID
- Soh-Med--24-12-04MS
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Magnetic Resonance Cholangiopancreatography as Compared to Ultrasound and Computed Tomography in Patients With Obstructive Jaundice
- ClinicalTrials.gov ID
- NCT06754397
- Acronym / sponsor ID
- Soh-Med--24-12-04MS
- Conditions
- Obstructive Jaundice
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MRCP as a diagnostic role to determine the presence and severity of biliary and pancreatic ductal dilatation. It can also detect the length of the stricture as well as the exact cause and location of the obstructing lesion in comparison to other modalities.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with obstructive jaundice | – | Diagnostic Test: Magnetic Resonance CholangiopancreatographyMRCP as a role that is used as a non-invasive diagnostic tool for visualizing the pancreaticobiliary tree without the use of contrast media |
Who may qualify
- Ages
- 15 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.
Key inclusion criteria (1 listed)
- Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance CholangiopancreatographyAlso: Ultrasound, Computed tomographyThree 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 | Diagnostic test | Patients diagnosed with obstructive jaundice |
Primary outcome
Diagnostic accuracy of Magnetic Resonance Cholangiopancreatography in patients with obstructive jaundice according to the findings
Time frame: Within twelve months
Magnetic Resonance Cholangiopancreatography findings in patients with obstructive jaundice comparing to findings of ERCP/ PTC and histopathology .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hisham A Amin, A. professor contact
Magdy M Amin, Professor study director
Medical research ethics committee - Sohag university
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Jaundice, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demiana M Soliman, Resident (01211992362, r.demiana.mohsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of Magnetic Resonance Cholangiopancreatography in patients with obstructive jaundice according to the findings (time frame: Within twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.