Portosystemic Collateral VeinsNCT04538209
Effect of Variceal Eradication on Portal Circulation
An observational study of Portosystemic Collateral Veins, run by Assiut University.
Trial summary
Study the effect of variceal eradication on portal circulation, liver stiffness and Child-Pugh and MELD scores in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Portosystemic Collateral Veins
- What is being tested?
- Abdominal computed tomography with angiography.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 15 May 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with documented liver cirrhosis (Based on clinical, laboratory and ultrasonographic findings) undergoing either primary or secondary prophylaxis variceal eradication at endoscopy unit of El-Rajhi hospital, Assuit University.
Who may be able to join
- • Age between 18 and 70 years old.
- Patient with documented liver cirrhosis undergoing either primary or secondary prophylactic variceal eradication.
- Liver cirrhosis with Child-Pugh score A and B.
Who cannot join
- • Age less than 18 years.
- Have contraindications to computed abdominal CT-angiography (e.g. allergy to all suitable contrast agents, renal failure).
- Patients with history of recent significant bleeding varices.
- Previous history of variceal ligation, sclerotherapy, and TIPS operation.
- Patients with isolated gastric varices.
- Patients with HCC or other malignancies.
Show all 10Show fewer
- End-stage liver disease (Child score more than 9).
- Patients with malignant portal vein thrombosis.
- Patients with non-cirrhotic portal hypertension.
- Patients refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Portal Circulation Before and After Variceal Eradication in Patients With Liver Cirrhosis.
Study the effect of variceal eradication on portal circulation, liver stiffness and Child-Pugh and MELD scores in patients with liver cirrhosis.
Read the detailed description
Portosystemic collateral circulation is a consequence of portal hypertension, which occurs in chronic liver disease and is responsible for numerous complications.
Gastric and oesophageal varices are two of common portosystemic collaterals, patients usually presented with hematemesis, melena, or both, ultimately 20% is the mortality during the first attack.
Although both band ligation and sclerotherapy are effective modalities of treatment in controlling acute variceal bleeding, in preventing future variceal bleeding as well as in eradicating varices with very few complications , their effects on portal circulation have raised concerns among hepatologist.
Information about collateral pathways is especially relevant when interventional procedures or surgery is indicated because inadvertent distribution of these vessels can cause significant bleeding.
Few studies pointed on development of new portosystemic collaterals post variceal eradication depending on abdominal computed tomography (CT ) compared to pre-variceal eradication as showed paraoesophageal varices, retro-gastric varices not visualized with endoscopy ,or large deep gastric collaterals that may increase risk for rebleeding.
Also, liver stiffness measurement and indirect markers of portal hypertension have been correlated with the severity of portal hypertension and have been used to predict the presence of varices, and there is rising question what about effect of variceal eradication on liver stiffness.
The Child-Pugh and MELD scores were significantly higher for patients with gastric variceal bleeding , and the question here is variceal eradication can improve Child-Pugh and MELD scores or there is no effect.
- Conditions
- Portosystemic Collateral Veins
- Being tested
- Abdominal computed tomography with angiography.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal computed tomography with angiography.Radiation
technique of combing a Computed Tomography scan with the injection of dye to create pictures of the portal circulation and portosystemic collaterals veins.
| Study group | Role | What they receive |
|---|---|---|
| canditates for variceal eradication | patients with documented liver cirrhosis (Based on clinical, laboratory and ultrasonographic findings) undergoing either primary or secondary prophylaxis variceal eradication at endoscopy unit of El-Rajhi hospital, Assuit University Receives: Radiation: Abdominal computed tomography with angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the effect of variceal eradication on portal circulation, liver stiffness and Child-Pugh and MELD scores in patients with liver cirrhosis.
Study the effect of variceal eradication on portal circulation and development of new portosystemic collaterals had not be found before variceal eradication in patients with liver cirrhosis
Measured: 4 years
Secondary outcomes (1)
Study the effect of variceal eradication on liver stiffness and Child-Pugh and MELD scores in patient with liver cirrhosis
study how can variceal eradication affect liver elasticity, liver function so can calculate Child-Pugh and MELD scores which can life expectancy of patients with liver cirrhosis
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start15 Jan 2021 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Portosystemic Collateral VeinsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Yousef Mohammed, Assiut University
- Investigators
- Esraa Swifee, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538209
- Sponsor's protocol ID
- portal circulation assessment
- Status last verified
- Aug 2020
- First submitted
- 30 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdel-Aty M, Fouad M, Sallam MM, Elgohary EA, Ismael A, Nawara A, Hawary B, Tag-Adeen M, Khaled S. Incidence of HCV induced-Esophageal varices in Egypt: Valuable knowledge using data mining analysis. Medicine (Baltimore). 2017 Jan;96(4):e5647. doi: 10.1097/MD.0000000000005647.
PubMed 28121921Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
PubMed 27786365Augustin S, Millan L, Gonzalez A, Martell M, Gelabert A, Segarra A, Serres X, Esteban R, Genesca J. Detection of early portal hypertension with routine data and liver stiffness in patients with asymptomatic liver disease: a prospective study. J Hepatol. 2014 Mar;60(3):561-9. doi: 10.1016/j.jhep.2013.10.027. Epub 2013 Nov 6.
PubMed 24211744Lahbabi M, Mellouki I, Aqodad N, Elabkari M, Elyousfi M, Ibrahimi SA, Benajah DA. Esophageal variceal ligation in the secondary prevention of variceal bleeding: Result of long term follow-up. Pan Afr Med J. 2013 May 3;15:3. doi: 10.11604/pamj.2013.15.3.2098. Print 2013.
PubMed 23847700
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Portal Circulation Before and After Variceal Eradication in Patients With Liver Cirrhosis.
- ClinicalTrials.gov ID
- NCT04538209
- Acronym / sponsor ID
- portal circulation assessment
- Conditions
- Portosystemic Collateral Veins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 4 Sep 2020 (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.
Study the effect of variceal eradication on portal circulation, liver stiffness and Child-Pugh and MELD scores in patients with liver cirrhosis.
Detailed description
Portosystemic collateral circulation is a consequence of portal hypertension, which occurs in chronic liver disease and is responsible for numerous complications.
Gastric and oesophageal varices are two of common portosystemic collaterals, patients usually presented with hematemesis, melena, or both, ultimately 20% is the mortality during the first attack.
Although both band ligation and sclerotherapy are effective modalities of treatment in controlling acute variceal bleeding, in preventing future variceal bleeding as well as in eradicating varices with very few complications , their effects on portal circulation have raised concerns among hepatologist.
Information about collateral pathways is especially relevant when interventional procedures or surgery is indicated because inadvertent distribution of these vessels can cause significant bleeding.
Few studies pointed on development of new portosystemic collaterals post variceal eradication depending on abdominal computed tomography (CT ) compared to pre-variceal eradication as showed paraoesophageal varices, retro-gastric varices not visualized with endoscopy ,or large deep gastric collaterals that may increase risk for rebleeding.
Also, liver stiffness measurement and indirect markers of portal hypertension have been correlated with the severity of portal hypertension and have been used to predict the presence of varices, and there is rising question what about effect of variceal eradication on liver stiffness.
The Child-Pugh and MELD scores were significantly higher for patients with gastric variceal bleeding , and the question here is variceal eradication can improve Child-Pugh and MELD scores or there is no effect.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| canditates for variceal eradication | – | Radiation: Abdominal computed tomography with angiography.patients with documented liver cirrhosis (Based on clinical, laboratory and ultrasonographic findings) undergoing either primary or secondary prophylaxis variceal eradication at endoscopy unit of El-Rajhi hospital, Assuit University |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with documented liver cirrhosis (Based on clinical, laboratory and ultrasonographic findings) undergoing either primary or secondary prophylaxis variceal eradication at endoscopy unit of El-Rajhi hospital, Assuit University.
Key inclusion criteria (3 listed)
- • Age between 18 and 70 years old.
Key exclusion criteria (10 listed)
- • Age less than 18 years.
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 |
|---|---|---|
| Abdominal computed tomography with angiography.technique of combing a Computed Tomography scan with the injection of dye to create pictures of the portal circulation and portosystemic collaterals veins. | Radiation | canditates for variceal eradication |
Primary outcome
Study the effect of variceal eradication on portal circulation, liver stiffness and Child-Pugh and MELD scores in patients with liver cirrhosis.
Time frame: 4 years
Study the effect of variceal eradication on portal circulation and development of new portosystemic collaterals had not be found before variceal eradication in patients with liver cirrhosis
1 secondary outcome
Study the effect of variceal eradication on liver stiffness and Child-Pugh and MELD scores in patient with liver cirrhosis
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Background: PubMed 28121921Abdel-Aty M, Fouad M, Sallam MM, Elgohary EA, Ismael A, Nawara A, Hawary B, Tag-Adeen M, Khaled S. Incidence of HCV induced-Esophageal varices in Egypt: Valuable knowledge using data mining analysis. Medicine (Baltimore). 2017 Jan;96(4):e5647. doi: 10.1097/MD.0000000000005647.
- Background: PubMed 27786365Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
- Background: PubMed 24211744Augustin S, Millan L, Gonzalez A, Martell M, Gelabert A, Segarra A, Serres X, Esteban R, Genesca J. Detection of early portal hypertension with routine data and liver stiffness in patients with asymptomatic liver disease: a prospective study. J Hepatol. 2014 Mar;60(3):561-9. doi: 10.1016/j.jhep.2013.10.027. Epub 2013 Nov 6.
- Background: PubMed 23847700Lahbabi M, Mellouki I, Aqodad N, Elabkari M, Elyousfi M, Ibrahimi SA, Benajah DA. Esophageal variceal ligation in the secondary prevention of variceal bleeding: Result of long term follow-up. Pan Afr Med J. 2013 May 3;15:3. doi: 10.11604/pamj.2013.15.3.2098. Print 2013.
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.
Esraa Swifee principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Portosystemic Collateral Veins, run by Assiut 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 3 inclusion and 10 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 4 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Swifee, M.A gastroenterology (+201000700150, esraayousef27@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the effect of variceal eradication on portal circulation, liver stiffness and Child-Pugh and MELD scores in patients with liver cirrhosis. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538209, which also lists 4 linked publications.
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 4 Sep 2020.