Cirrhosis PortalPortalflowNCT05228509
Portal Vein Flow Velocity as a Screening Tool for Oesophageal Varices in Cirrhotic Patients
An observational study of Cirrhosis Portal, run by Peter atef at 2 sites in Egypt.
Trial summary
Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cirrhosis Portal
- How many people
- 75 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 May 2021to 30 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Cirrhotic patients with or without E
Who may be able to join
- cirrhotic patients with oesophageal varices
- cirrhotic patients without oesophageal varices
Who cannot join
- Patients with hepato-cellular carcinomas [HCCs], portal vein thrombosis, hepatic encephalopathy.
- Patients with positive HCV antibody, but without liver cirrhosis diagnostic criteria
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
43
Asyut, Manfalout, 088
- Recruiting
Egypt .assiut.manfalout
Asyut, Manfalout, 088
About this study
Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy
Read the detailed description
Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy with its high cost \& complications Using portal vein flow velocity and the relation between it \& presence of oesophageal varices in cirrhotic patient \& its efficacy as a primary tool for these cases
- Conditions
- Cirrhosis Portal
What is being measured
The primary outcome is the main question the study is designed to answer.
Using upper GIT endoscopy to detect the presence or absence of oesophageal varices
Non-invasive screening tool for esophageal varices:
Aspartate aminotransferase-to-platelet ratio index (APRI) ... Doppler ultrasound of portal system Elastography both of liver and spleen... -Research outcome measures:
- Primary (main): Using upper GIT endoscopy to detect the presence or absence of oesophageal varices, and to detect the best and most available non- invasive predictor for it.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start4 May 2021
- Primary completion2 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis PortalStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peter atef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter atef, Assiut University
- Investigators
- Peter At Munir, Master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228509
- Sponsor's protocol ID
- Patef
- Acronym
- Portalflow
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Vein Flow Velocity as a Screening Tool for Oesophageal Varices in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT05228509
- Acronym / sponsor ID
- Portalflow / Patef
- Conditions
- Cirrhosis Portal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Peter atefUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 2 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Feb 2022 (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.
Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy
Detailed description
Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy with its high cost \& complications Using portal vein flow velocity and the relation between it \& presence of oesophageal varices in cirrhotic patient \& its efficacy as a primary tool for these cases
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cirrhotic patients with or without E
Key inclusion criteria (2 listed)
- cirrhotic patients with oesophageal varices
- cirrhotic patients without oesophageal varices
Key exclusion criteria (2 listed)
- Patients with hepato-cellular carcinomas [HCCs], portal vein thrombosis, hepatic encephalopathy.
- Patients with positive HCV antibody, but without liver cirrhosis diagnostic criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Using upper GIT endoscopy to detect the presence or absence of oesophageal varices
Time frame: 3 years
Non-invasive screening tool for esophageal varices: Aspartate aminotransferase-to-platelet ratio index (APRI) ... Doppler ultrasound of portal system Elastography both of liver and spleen... -Research outcome measures: a. Primary (main): Using upper GIT endoscopy to detect the presence or absence of oesophageal varices, and to detect the best and most available non- invasive predictor for it.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
Related trials for Cirrhosis Portal
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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. This study is not recruiting at the moment.
Peter At Munir, Master principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis Portal, run by Peter atef at 2 sites in Egypt.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter At Rizk (01553529181, Peteratef662@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using upper GIT endoscopy to detect the presence or absence of oesophageal varices (time frame: 3 years). 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 18 Jan 2024.