Portal Vein ThrombosisNCT06117488
Risk Factors and Management Outcome of Chronic Portal Vein Thrombosis in Children
An observational study of Portal Vein Thrombosis, run by Assiut University.
Trial summary
The aim of study is to evaluate different etiological and risk factors that lead to chronic portal vein thrombosis and to delineate a management plan for chronic portal vein thrombosis in children. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- endoscopy
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Dec 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 3 months to 18 years
- All sexes
- Child, Adult
Study population: Children and adolescents aged from 3 months to 18 years' old. Those with chronic portal vein thrombosis.
Who may be able to join
- Children and adolescents with Chronic Portal vein thrombosis admitted to Pediatric Gastroenterology, Hepatology and Endoscopy units at Assiut university children hospital (AUCH) in the previous year 2022 from 1/1/2022 to 31/12/2022.
- Those with chronic portal vein thrombosis aged from 3 months to 18 years' old.
Who cannot join
- Patients aged less than 3 months and more than 18 years' old. Those with acute portal vein thrombosis. Children with portal hypertension in absence of chronic portal vein thrombosis.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of study is to evaluate different etiological and risk factors that lead to chronic portal vein thrombosis and to delineate a management plan for chronic portal vein thrombosis in children.
Read the detailed description
Chronic Portal vein thrombosis (PVT) is defined as thrombosis that develops in the trunk of the portal vein, including its right and/or left intrahepatic branches of more than 5 weeks duration. This thrombus may extend to the splenic or superior mesenteric veins. The causes of chronic PVT in children are not entirely known, but several factors that predispose to this pathology are described. These are classified into three categories: local factors that can cause injury to the portal vein (abdominal infections, abdominal surgery, umbilical catheter), general factors (procoagulant status), and, less often, vascular malformation. The most common cause is umbilical vein catheterization (UVC). Among the general factors that predispose to venous thrombosis are thrombophilia, sepsis, and dehydration. Deficiency or qualitative abnormalities of anti-coagulation factors (antithrombin III, protein C, protein S, and activated protein C resistance) often predispose to thrombotic events, including PVT. Thrombophilia is incriminated in 35% of cases of PVT in children. For this reason, children with PVT, and especially those that associate other risk factors (UVC), should be screened for inherited prothrombotic disorders: prothrombin 20210 mutation (PTHR), factor V Leiden (FVL), methylenetetrahydrofolate reductase (MTHFR) genes deficiency, or metabolic defects like hyper homocysteinemia. Congenital abnormalities (portal vein stenosis, atresia, or agenesis) are rarely involved in PVT. Furthermore, early PVT after liver transplantation with cadaveric graft was described in adults. Even less often in children, PVT after splenectomy for hematologic diseases was also described. An association between more than one factor is frequently observed, which further increases the risk of thrombosis. In almost 50% of cases, the etiology of PVT remains unknown.
PVT patients initially present with upper gastrointestinal bleeding (UGIB) or splenomegaly on routine clinical examination in asymptomatic individuals. The initial presence of hematemesis is usually dramatic in a previously healthy child, with past history of morbidity, often without remarkable intercurrent events. Melena may also be observed, but it is less common than hematemesis. The child can be lethargic, with signs of orthostatic hypotension. The clinical examination revealing splenomegaly in a child with UGIB indicates esophageal varices as the most probable site for the bleeding. Less frequently, the diagnosis can be based on the investigation of a child with abdominal pain or with complications related to hypersplenism. The physical examination may reveal splenomegaly; hepatomegaly is not common in children with PVT without underlying liver disease, as well as stigmata of chronic liver disease. PVT should be suspected in all children with splenomegaly, without hepatomegaly and hematemesis, with normal liver function test results. Liver biopsy is normal in children without associated cirrhosis.
Abdominal Doppler ultrasonography is the most widely used diagnostic exam in pediatric patients, with a high sensitivity and specificity, even though it is an operator-dependent diagnostic method. Chronicity of PVT is defined by Doppler ultrasonography by means of visualization of the formation of new vessels around the thrombus (cavernoma). Some diagnostic exams should not be routinely used in pediatric patients due to their risk: splenoportography and arterial portography, nuclear magnetic resonance (angiography), computed tomography (portogram). All patients must be submitted to upper gastrointestinal endoscopy to check for the presence of esophagogastric varices, which will allow for a better planned therapeutic approach. Laboratory exams show normal liver function in most patients, except in those who have a prolonged decrease in portal circulation, or portal biliopathy.
The treatment of portal venous obstruction depends upon the patient's age, the site and nature of the obstruction and the clinical features. Endoscopic variceal ligation (EVL) is the primary choice for the management of variceal bleeding in children. This treatment may be technically difficult in young and small children; sclerotherapy is then recommended as an alternative approach in such cases. Beta adrenergic blockade may play a role in secondary prophylaxis as they reduce the risk of rebleeding and improve survival after variceal bleed. Decompressive shunt surgery should be considered in cases with failed endotherapy. It is also indicated for correcting symptomatic portal hypertensive biliopathy, symptomatic hypersplenism and 'on demand' one-time treatment. Oesophageal transection with or without splenectomy is less useful to control bleeding because of a high risk of late rebleeding and reappearance of varices, but can be resorted to as a nonshunt option in patients with portosystemic encephalopathy, hepatopulmonary syndrome or portopulmonary syndrome. Portal vein thrombosis was considered a major obstacle to liver transplantation which led to increased surgical complexity and perioperative morbidity and mortality.
- Conditions
- Portal Vein Thrombosis
- Being tested
- endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyDevice
Also called drug
gastro duodenal endoscoe
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Factors and Management Outcome of Chronic Portal Vein Thrombosis in Children
-Describe demographic and clinical data of children and adolescents with (PVT) admitted to Pediatric Gastroenterology, Hepatology and Endoscopy units at Assiut university children hospital (AUCH) in the previous year 2022. Assess the outcome of (PVT) in children and adolescents admitted to (AUCH).
Describe the distribution of etiologies of (PVT) in children and adolescents at Assiut University Children's Hospital.
-Clinical examination which include:
- Vital signs: heart rate, blood pressure, respiratory rate, and temperature.
- General examination: pallor, jaundice and cyanosis.
- Anthropometric measurements: weight (kg), height (m) and BMI.
- Cardiac, chest and neurological examination.
- Local abdominal examination for: abdominal distention, hepatomegaly, splenomegaly, ascites and dilated abdominal wall veins.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Aly Fathy Shehata, Assiut University
- Investigators
- Ashraf Mohammed Alsagheer, Lecturer, Study director, Assiut university, Faculty of midicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117488
- Sponsor's protocol ID
- chronic portal vein thrombosis
- Status last verified
- Nov 2023
- First submitted
- 6 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Management Outcome of Chronic Portal Vein Thrombosis in Children
- ClinicalTrials.gov ID
- NCT06117488
- Acronym / sponsor ID
- chronic portal vein thrombosis
- Conditions
- Portal Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Nov 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.
The aim of study is to evaluate different etiological and risk factors that lead to chronic portal vein thrombosis and to delineate a management plan for chronic portal vein thrombosis in children.
Detailed description
Chronic Portal vein thrombosis (PVT) is defined as thrombosis that develops in the trunk of the portal vein, including its right and/or left intrahepatic branches of more than 5 weeks duration. This thrombus may extend to the splenic or superior mesenteric veins. The causes of chronic PVT in children are not entirely known, but several factors that predispose to this pathology are described. These are classified into three categories: local factors that can cause injury to the portal vein (abdominal infections, abdominal surgery, umbilical catheter), general factors (procoagulant status), and, less often, vascular malformation. The most common cause is umbilical vein catheterization (UVC). Among the general factors that predispose to venous thrombosis are thrombophilia, sepsis, and dehydration. Deficiency or qualitative abnormalities of anti-coagulation factors (antithrombin III, protein C, protein S, and activated protein C resistance) often predispose to thrombotic events, including PVT. Thrombophilia is incriminated in 35% of cases of PVT in children. For this reason, children with PVT, and especially those that associate other risk factors (UVC), should be screened for inherited prothrombotic disorders: prothrombin 20210 mutation (PTHR), factor V Leiden (FVL), methylenetetrahydrofolate reductase (MTHFR) genes deficiency, or metabolic defects like hyper homocysteinemia. Congenital abnormalities (portal vein stenosis, atresia, or agenesis) are rarely involved in PVT. Furthermore, early PVT after liver transplantation with cadaveric graft was described in adults. Even less often in children, PVT after splenectomy for hematologic diseases was also described. An association between more than one factor is frequently observed, which further increases the risk of thrombosis. In almost 50% of cases, the etiology of PVT remains unknown.
PVT patients initially present with upper gastrointestinal bleeding (UGIB) or splenomegaly on routine clinical examination in asymptomatic individuals. The initial presence of hematemesis is usually dramatic in a previously healthy child, with past history of morbidity, often without remarkable intercurrent events. Melena may also be observed, but it is less common than hematemesis. The child can be lethargic, with signs of orthostatic hypotension. The clinical examination revealing splenomegaly in a child with UGIB indicates esophageal varices as the most probable site for the bleeding. Less frequently, the diagnosis can be based on the investigation of a child with abdominal pain or with complications related to hypersplenism. The physical examination may reveal splenomegaly; hepatomegaly is not common in children with PVT without underlying liver disease, as well as stigmata of chronic liver disease. PVT should be suspected in all children with splenomegaly, without hepatomegaly and hematemesis, with normal liver function test results. Liver biopsy is normal in children without associated cirrhosis.
Abdominal Doppler ultrasonography is the most widely used diagnostic exam in pediatric patients, with a high sensitivity and specificity, even though it is an operator-dependent diagnostic method. Chronicity of PVT is defined by Doppler ultrasonography by means of visualization of the formation of new vessels around the thrombus (cavernoma). Some diagnostic exams should not be routinely used in pediatric patients due to their risk: splenoportography and arterial portography, nuclear magnetic resonance (angiography), computed tomography (portogram). All patients must be submitted to upper gastrointestinal endoscopy to check for the presence of esophagogastric varices, which will allow for a better planned therapeutic approach. Laboratory exams show normal liver function in most patients, except in those who have a prolonged decrease in portal circulation, or portal biliopathy.
The treatment of portal venous obstruction depends upon the patient's age, the site and nature of the obstruction and the clinical features. Endoscopic variceal ligation (EVL) is the primary choice for the management of variceal bleeding in children. This treatment may be technically difficult in young and small children; sclerotherapy is then recommended as an alternative approach in such cases. Beta adrenergic blockade may play a role in secondary prophylaxis as they reduce the risk of rebleeding and improve survival after variceal bleed. Decompressive shunt surgery should be considered in cases with failed endotherapy. It is also indicated for correcting symptomatic portal hypertensive biliopathy, symptomatic hypersplenism and 'on demand' one-time treatment. Oesophageal transection with or without splenectomy is less useful to control bleeding because of a high risk of late rebleeding and reappearance of varices, but can be resorted to as a nonshunt option in patients with portosystemic encephalopathy, hepatopulmonary syndrome or portopulmonary syndrome. Portal vein thrombosis was considered a major obstacle to liver transplantation which led to increased surgical complexity and perioperative morbidity and mortality.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged from 3 months to 18 years' old. Those with chronic portal vein thrombosis.
Key inclusion criteria (2 listed)
- Children and adolescents with Chronic Portal vein thrombosis admitted to Pediatric Gastroenterology, Hepatology and Endoscopy units at Assiut university children hospital (AUCH) in the previous year 2022 from 1/1/2022 to 31/12/2022.
- Those with chronic portal vein thrombosis aged from 3 months to 18 years' old.
Key exclusion criteria (1 listed)
- Patients aged less than 3 months and more than 18 years' old. Those with acute portal vein thrombosis. Children with portal hypertension in absence of chronic portal vein thrombosis.
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 |
|---|---|---|
| endoscopyAlso: druggastro duodenal endoscoe | Device | – |
Primary outcome
Risk Factors and Management Outcome of Chronic Portal Vein Thrombosis in Children
Time frame: baseline
-Describe demographic and clinical data of children and adolescents with (PVT) admitted to Pediatric Gastroenterology, Hepatology and Endoscopy units at Assiut university children hospital (AUCH) in the previous year 2022. Assess the outcome of (PVT) in children and adolescents admitted to (AUCH). Describe the distribution of etiologies of (PVT) in children and adolescents at Assiut University Children's Hospital. -Clinical examination which include: * Vital signs: heart rate, blood pressure, respiratory rate, and temperature. * General examination: pallor, jaundice and cyanosis. * Anthropometric measurements: weight (kg), height (m) and BMI. * Cardiac, chest and neurological examination. * Local abdominal examination for: abdominal distention, hepatomegaly, splenomegaly, ascites and dilated abdominal wall veins.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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. This study is not recruiting at the moment.
Ashraf Mohammed Alsagheer, Lecturer study director
Assiut university, Faculty of midicine
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Vein Thrombosis, 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 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 7 Nov 2023. 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 Asmaa Aly Fathy, resident doctor (01096925454, asmaaali199732@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Factors and Management Outcome of Chronic Portal Vein Thrombosis in Children (time frame: baseline). 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 7 Nov 2023.