Color Doppler US and TE as Predictors for Presence of Gastroesophageal Varices and Variceal Bleeding in Patients With LC

NCT05891184 | Unknown

• 1 other identifier: Dopper Us and TE in LC
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the ability of Doppler ultrasonography of the portal vein and liver stiffness measurement using Transient Elestoghraphy in predicting prescence of gastroesophageal variceal and variceal bleeding in patients with liver cirrhosis

Conditions

Gastroesophageal Varices Hemorrhage

Keywords

color doppler ultrasound; transient elastography; liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• comparing the ability of ultrasound and transient elastography in detecting presence of gastroesoghageal varices to upper endoscopy in liver cirrhosis

  evaluate the ability of Doppler ultrasonography of the portal vein and liver stiffness measurement using Transient Elestoghraphy in predicting prescence of gastroesophageal varices and variceal bleeding in patients with liver cirrhosis

  baseline

Study Arms (3)

1

the 1st group will be patients with current or past history of variceal bleeding,

Device: color doppler ultrasound, transient elastography, upper endoscopy

2

the 2nd group will be patients having gastroesophageal varices without variceal bleeding,

Device: color doppler ultrasound, transient elastography, upper endoscopy

3

3ed group will be patients without gastroesophageal varices or variceal bleeding.

Device: color doppler ultrasound, transient elastography, upper endoscopy

Interventions

color doppler ultrasound, transient elastography, upper endoscopy DEVICE

Abdominal US: for detecting the portal hypertension, splenomegaly and portosystemic abdominal collaterals . Doppler US: detecting the diameter and mean blood flow velocity, blood flow volume, perfusion pressure gradient, congestion index, resistive index, pulsatility index of hepatic artery and platelet count-to-spleen diameter ratio will be performed using logic 10 with a 3.5-MHz duplex convex transducer, in supine position after overnight fasting, with holding their breath in maximal expiration in order to minimize the effect of respiration, body position and postprandial changes on the portal flow Endoscopy : Using Sarin classification ( The presence of esophageal varices, their number, exact location, shape, size and cherry-red spots ) Fibroscan: using the standard-probe, and on a fasting (4 h) patient lying flat on his/her back, with the right arm tucked behind the head to facilitate access to the right upper quadrant.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A case control study will be performed on outpatients and hospitalized patients presented with liver cirrhosis to the department of Tropical medicine, Gastroenterology and Hepatology, Al-Rajhi liver hospital

You may qualify if:

• Patients \> 18 years old.
• with Liver cirrhosis presented with or without variceal bleeding.
• or any other complaint, or coming for follow up for their chronic liver disease.
• with body mass index less than 35.

You may not qualify if:

• Patients suffering from grade III or grade IV encephalopathy, hepatocellular carcinoma, portal vein thrombosis, and moderate or marked ascites
• Patients who received drugs that may have a major effect on portal pressure.
• Patients less than 18 years, patients with BMI more than or equal to 35.
• pregnant patient.
• Patients who refused to be involved in our study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Plestina S, Pulanic R, Kralik M, Plestina S, Samarzija M. Color Doppler ultrasonography is reliable in assessing the risk of esophageal variceal bleeding in patients with liver cirrhosis. Wien Klin Wochenschr. 2005 Oct;117(19-20):711-7. doi: 10.1007/s00508-005-0424-x.

  PMID: 16416372 BACKGROUND

• Xia S, Ren X, Ni Z, Zhan W. A Noninvasive Method-Shear-Wave Elastography Compared With Transient Elastography in Evaluation of Liver Fibrosis in Patients With Chronic Hepatitis B. Ultrasound Q. 2019 Jun;35(2):147-152. doi: 10.1097/RUQ.0000000000000399.

  PMID: 30724863 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Hanan Nafeh, professor

  Vice president of graduate studies of Assiut University

  STUDY DIRECTOR

Central Study Contacts

Reham Mamdouh, lesnce

CONTACT

01025242310; rehamkemaly22@gmail.com

Waleed Attia, A.professor

CONTACT

01554544895; wallo403a@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Waleed Attia, Hanan Nafeh

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-07