Portal HypertensionNCT06097715
Clinical,Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases
A study testing upper gastrointestinal endoscopy and 1- Complete blood count 2- Coagulation profile in people with Portal Hypertension, run by Sohag University at 1 site in Egypt.
Trial summary
Portal hypertension is a significant cause of morbidity and mortality in children with chronic liver disease and portal vein obstruction. It results in severe complications such as ascites, hepatic encephalopathy and gastrointestinal variceal bleeding. (Sutton et. al., 2018). Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- upper gastrointestinal endoscopy and 1- Complete blood count 2- Coagulation profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2023to Oct 2024
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1- Age: < 18 years 2- Manifestations of hepatic disease like jaundice, hepatic encephalopathy, organomegally.
- 3- Children previously diagnosed with chronic liver disease
Who cannot join
- 1- Age: > 18 years. 2- Non compliant child during technique of elastography. 3- Patient with ascites. 4- Patient with portosystemic shunt surgery
Trial locations and contacts
1 site in 1 country.
Mohamed M Fawaz, professor contact
About this study
Official title: Clinical, Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases
Portal hypertension is a significant cause of morbidity and mortality in children with chronic liver disease and portal vein obstruction. It results in severe complications such as ascites, hepatic encephalopathy and gastrointestinal variceal bleeding. (Sutton et. al., 2018).
Esophageal varices is an important manifestation of portal hypertension that develops over time in children with chronic liver disease. The risk of esophageal varices hemorrhage increases depending on the underlying disease as well as the duration of the disease and the mortality rate as high as 5% - 20 % during patient follow up. Invasive procedures such as gastroscopy are performed repeatedly to detect the presence and progression of esophageal varices. Many non-invasive methods have been investigated to their efficacy in determining the presence of esophageal varices and the risk of complications in the presence of portal hypertension. (Taşkın et.al., 2023).
Read more
Early diagnosis of portal hypertension is often difficult as it can be asymptomatic. During this stage, the patient may feel nothing except for mild fatigue or abdominal discomfort and therefore, patients mostly go undiagnosed (Hartl et.al., 2021). (Selicean et.al., 2021). However, it is worth noting that some of the results from medical investigation may be abnormal during this stage. These include abnormal liver function, abnormal routine blood examination (thrombocytopenia), and changes in the stiffness of the liver which can be found during ultrasound despite the patient being asymptomatic. ( Mohanty et al., 2021).
Though the gold standard to diagnose portal hypertension is hepatic venous pressure gradient (HVPG) and a value more than 10 mmHg defines clinically significant portal hypertension (CSPH) ( Man Zhang et.al., 2022). Since HVPG measurement is scarcely available and invasive, several non-invasive tests are used as surrogate markers of CSPH. Amongst them, elastography techniques measuring liver stiffness (LS) and spleen stiffness (SS) are the extensively studied ones which can be done by elastography machines that can be attached to conventional ultrasound (USG) machines . Amongst them, 2D-shear wave elastography (2D-SWE) is the most recent one, and it assesses stiffness and related parameters by tracking shear waves propagated through a media. (Sattanathan et.al., 2023).
- Conditions
- Portal Hypertension
- Being tested
- upper gastrointestinal endoscopy, 1- Complete blood count 2- Coagulation profile
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper gastrointestinal endoscopyDiagnostic test
Upper gastrointestinal endoscopy to asses present of esophageal varices and will be done to all patient group
1- Complete blood count 2- Coagulation profileDiagnostic test
cmplete blood count to detect thrombocytopenia, liver function test to detect if they are elevated,and any impaired coagulation profile
| Study group | Role | What they receive |
|---|---|---|
| patient group | Active comparator | patients which previosly diagnosed with chronic liver diseases or presented with manifestations of chronic liver diseases Receives: Diagnostic Test: upper gastrointestinal endoscopy; Diagnostic Test: 1- Complete blood count 2- Coagulation profile |
| control group | Active comparator | children in the same age and sex of the patient group and presented to Sohag Universty Hospital due to any complaint rather than hepatic and gastrointestinal disease. Receives: Diagnostic Test: 1- Complete blood count 2- Coagulation profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with early detection of portal hypertension in patient with chronic liver diseases
we aim to early of portal hypertension in patient with chronic liver diseases before occurance of complications as esophageal bleeding
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (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 Portal HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Abuelfadl, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097715
- Sponsor's protocol ID
- Soh-Med-23-10-02MD
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sutton H, Dhawan A, Grammatikopoulos T. Non-invasive Markers of Portal Hypertension: Appraisal of Adult Experience and Potential Utilisation in Children. J Pediatr Gastroenterol Nutr. 2018 Apr;66(4):559-569. doi: 10.1097/MPG.0000000000001882.
PubMed 29287004Zhang M, Jin H, Cao J, Ren R, Jia M, Yang Y, Li X, Chen M, Li S, Huang L, Ling W. Application of Ultrasound Elastography in Assessing Portal Hypertension. Diagnostics (Basel). 2022 Sep 29;12(10):2373. doi: 10.3390/diagnostics12102373.
PubMed 36292062Hartl L, Jachs M, Desbalmes C, Schaufler D, Simbrunner B, Paternostro R, Schwabl P, Bauer DJM, Semmler G, Scheiner B, Bucsics T, Eigenbauer E, Marculescu R, Szekeres T, Peck-Radosavljevic M, Kastl S, Trauner M, Mandorfer M, Reiberger T. The differential activation of cardiovascular hormones across distinct stages of portal hypertension predicts clinical outcomes. Hepatol Int. 2021 Oct;15(5):1160-1173. doi: 10.1007/s12072-021-10203-9. Epub 2021 May 21.
PubMed 34021479Selicean S, Wang C, Guixe-Muntet S, Stefanescu H, Kawada N, Gracia-Sancho J. Regression of portal hypertension: underlying mechanisms and therapeutic strategies. Hepatol Int. 2021 Feb;15(1):36-50. doi: 10.1007/s12072-021-10135-4. Epub 2021 Feb 5.
PubMed 33544313
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases
- ClinicalTrials.gov ID
- NCT06097715
- Acronym / sponsor ID
- Soh-Med-23-10-02MD
- Conditions
- Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 24 Oct 2023 (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 hypertension is a significant cause of morbidity and mortality in children with chronic liver disease and portal vein obstruction. It results in severe complications such as ascites, hepatic encephalopathy and gastrointestinal variceal bleeding. (Sutton et. al., 2018).
Esophageal varices is an important manifestation of portal hypertension that develops over time in children with chronic liver disease. The risk of esophageal varices hemorrhage increases depending on the underlying disease as well as the duration of the disease and the mortality rate as high as 5% - 20 % during patient follow up. Invasive procedures such as gastroscopy are performed repeatedly to detect the presence and progression of esophageal varices. Many non-invasive methods have been investigated to their efficacy in determining the presence of esophageal varices and the risk of complications in the presence of portal hypertension. (Taşkın et.al., 2023).
Early diagnosis of portal hypertension is often difficult as it can be asymptomatic. During this stage, the patient may feel nothing except for mild fatigue or abdominal discomfort and therefore, patients mostly go undiagnosed (Hartl et.al., 2021). (Selicean et.al., 2021). However, it is worth noting that some of the results from medical investigation may be abnormal during this stage. These include abnormal liver function, abnormal routine blood examination (thrombocytopenia), and changes in the stiffness of the liver which can be found during ultrasound despite the patient being asymptomatic. ( Mohanty et al., 2021).
Though the gold standard to diagnose portal hypertension is hepatic venous pressure gradient (HVPG) and a value more than 10 mmHg defines clinically significant portal hypertension (CSPH) ( Man Zhang et.al., 2022). Since HVPG measurement is scarcely available and invasive, several non-invasive tests are used as surrogate markers of CSPH. Amongst them, elastography techniques measuring liver stiffness (LS) and spleen stiffness (SS) are the extensively studied ones which can be done by elastography machines that can be attached to conventional ultrasound (USG) machines . Amongst them, 2D-shear wave elastography (2D-SWE) is the most recent one, and it assesses stiffness and related parameters by tracking shear waves propagated through a media. (Sattanathan et.al., 2023).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | Active comparator | Diagnostic Test: upper gastrointestinal endoscopy, Diagnostic Test: 1- Complete blood count 2- Coagulation profilepatients which previosly diagnosed with chronic liver diseases or presented with manifestations of chronic liver diseases |
| control group | Active comparator | Diagnostic Test: 1- Complete blood count 2- Coagulation profilechildren in the same age and sex of the patient group and presented to Sohag Universty Hospital due to any complaint rather than hepatic and gastrointestinal disease. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1- Age: < 18 years 2- Manifestations of hepatic disease like jaundice, hepatic encephalopathy, organomegally.
- 3- Children previously diagnosed with chronic liver disease
Key exclusion criteria (1 listed)
- 1- Age: > 18 years. 2- Non compliant child during technique of elastography. 3- Patient with ascites. 4- Patient with portosystemic shunt surgery
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 |
|---|---|---|
| upper gastrointestinal endoscopyUpper gastrointestinal endoscopy to asses present of esophageal varices and will be done to all patient group | Diagnostic test | patient group |
| 1- Complete blood count 2- Coagulation profilecmplete blood count to detect thrombocytopenia, liver function test to detect if they are elevated,and any impaired coagulation profile | Diagnostic test | control group, patient group |
Primary outcome
Number of participants with early detection of portal hypertension in patient with chronic liver diseases
Time frame: 1 year
we aim to early of portal hypertension in patient with chronic liver diseases before occurance of complications as esophageal bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 29287004Sutton H, Dhawan A, Grammatikopoulos T. Non-invasive Markers of Portal Hypertension: Appraisal of Adult Experience and Potential Utilisation in Children. J Pediatr Gastroenterol Nutr. 2018 Apr;66(4):559-569. doi: 10.1097/MPG.0000000000001882.
- Background: PubMed 36292062Zhang M, Jin H, Cao J, Ren R, Jia M, Yang Y, Li X, Chen M, Li S, Huang L, Ling W. Application of Ultrasound Elastography in Assessing Portal Hypertension. Diagnostics (Basel). 2022 Sep 29;12(10):2373. doi: 10.3390/diagnostics12102373.
- Background: PubMed 34021479Hartl L, Jachs M, Desbalmes C, Schaufler D, Simbrunner B, Paternostro R, Schwabl P, Bauer DJM, Semmler G, Scheiner B, Bucsics T, Eigenbauer E, Marculescu R, Szekeres T, Peck-Radosavljevic M, Kastl S, Trauner M, Mandorfer M, Reiberger T. The differential activation of cardiovascular hormones across distinct stages of portal hypertension predicts clinical outcomes. Hepatol Int. 2021 Oct;15(5):1160-1173. doi: 10.1007/s12072-021-10203-9. Epub 2021 May 21.
- Background: PubMed 33544313Selicean S, Wang C, Guixe-Muntet S, Stefanescu H, Kawada N, Gracia-Sancho J. Regression of portal hypertension: underlying mechanisms and therapeutic strategies. Hepatol Int. 2021 Feb;15(1):36-50. doi: 10.1007/s12072-021-10135-4. Epub 2021 Feb 5.
- Individual participant dataSharing planned: Undecided
Related trials for Portal Hypertension
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
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.
Mohamed M Fawaz, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper gastrointestinal endoscopy and 1- Complete blood count 2- Coagulation profile in people with Portal Hypertension, run by Sohag University at 1 site 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 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Sarah M Abo El Fadl, spcialist (01061264464, sara_abuelfadl_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with early detection of portal hypertension in patient with chronic liver diseases (time frame: 1 year). 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 NCT06097715, 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 24 Oct 2023.