NCT06117488

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

October 6, 2023

Last Update Submit

November 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Interventions

endoscopyDEVICE

gastro duodenal endoscoe

Also known as: drug

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents aged from 3 months to 18 years' old. Those with chronic portal vein thrombosis.

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

EndoscopyDosage Forms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Ashraf Mohammed Alsagheer, Lecturer

    Assiut university, Faculty of midicine

    STUDY DIRECTOR

Central Study Contacts

Asmaa Aly Fathy, resident doctor

CONTACT

Mohammed Mahmoud Hamdy Alghazally, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2023

First Posted

November 7, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

November 7, 2023

Record last verified: 2023-11