NCT05228509

Brief Summary

Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

May 4, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

January 13, 2022

Last Update Submit

January 17, 2024

Conditions

Cirrhosis Portal

Outcome Measures

Primary Outcomes (1)

  • 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: 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.

    3 years

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cirrhotic patients with or without E

You may qualify if:

  • cirrhotic patients with oesophageal varices
  • cirrhotic patients without oesophageal varices

You may not qualify if:

  • Patients with hepato-cellular carcinomas \[HCCs\], portal vein thrombosis, hepatic encephalopathy.
  • Patients with positive HCV antibody, but without liver cirrhosis diagnostic criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

43

Asyut, Manfalout, 088, Egypt

RECRUITING

Egypt .assiut.manfalout

Asyut, Manfalout, 088, Egypt

RECRUITING

Study Officials

  • Peter At Munir, Master

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter At Rizk

CONTACT

01553529181Peteratef662@gmail.com

Atef Mu Rizk

CONTACT

01003938077Peteratef669@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Peter rizk

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 8, 2022

Study Start

May 4, 2021

Primary Completion

December 2, 2024

Study Completion

December 30, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

EG(2)