Gastroesophageal Varices HemorrhageNCT05891184
Color Doppler US and TE as Predictors for Presence of Gastroesophageal Varices and Variceal Bleeding in Patients With LC
An observational study of Gastroesophageal Varices Hemorrhage, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroesophageal Varices Hemorrhage
- What is being tested?
- color doppler ultrasound, transient elastography, upper endoscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Aug 2024
- 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 18 to 90 years
- All sexes
- Adult, Older adult
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
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Color Doppler Ultrasound and Transient Elestoghraphy as Predictors for Presence of Gastroesophageal Varices and Variceal Bleeding in Patients With Liver Cirrhosis
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
Read the detailed description
Liver cirrhosis incidence and prevalence have been increasing significantly over the years with varying evolutions of etiologies. It is a major cause of mortality and morbidity throughout the world, causing two million deaths per year worldwide (3.5% of all death) with 50% related to cirrhosis complications and 50% related to Hepatocellular Carcinoma and viral hepatitis infections.
Variceal bleeding is among leading causes of death in patients with liver cirrhosis and portal hypertension, In current clinical practice, evaluation of the risk of upper digestive tract bleeding is based on osephagogastroduodenoscopy. Although the occurrence of esophageal varices and the time of gastrointestinal bleeding in portal hypertension cannot be exactly predicted, there are some endoscopic and clinical signs associated with a high risk of bleeding: the size of the esophageal varices, the presence of cherry-red spots (red signs) Recent studies demonstrated that the severity of liver fibrosis, especially the presence of advanced fibrosis defined as stage F3 or F4 fibrosis, is the main driver of prognosis in cirrhosis and the main risk factor for developing not only liver-related events but also extrahepatic complications.
Liver stiffness measurement is a widely used non-invasive tool for the diagnosis of liver fibrosis and has high accuracy, and if combined with platelets count, it can be also used to identify patients at high risk for esophageal varices without the need for endoscopic screening.
Previous studies have demonstrated that liver stiffness can reflect the prognosis of patients with liver cirrhosis because it can indirectly reflect portal hypertension. Liver stiffness measured using transient elastography has been validated as a prognostic quantitative marker for the occurrence of liver-related complications, survival without liver-related death, and overall survival. However, LSM has not been well-verified in the esophageal variceal rebleeding, which is a critical event.
Recent studies indicate also that Doppler ultrasound findings of the portal system and hepatic artery could predict both the presence of varices and the risk of variceal bleeding in patient with portal hypertension and liver cirrhosis.
- Conditions
- Gastroesophageal Varices Hemorrhage
- Being tested
- color doppler ultrasound, transient elastography, upper endoscopy
- Keywords
- color doppler ultrasound, transient elastography, liver cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color doppler ultrasound, transient elastography, upper endoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | the 1st group will be patients with current or past history of variceal bleeding, Receives: Device: color doppler ultrasound, transient elastography, upper endoscopy | |
| 2 | the 2nd group will be patients having gastroesophageal varices without variceal bleeding, Receives: Device: color doppler ultrasound, transient elastography, upper endoscopy | |
| 3 | 3ed group will be patients without gastroesophageal varices or variceal bleeding. Receives: Device: color doppler ultrasound, transient elastography, upper endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Varices HemorrhageStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mamdouh Kemaly, Assiut University
- Investigators
- Hanan Nafeh, professor, Study director, Vice president of graduate studies of Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891184
- Sponsor's protocol ID
- Dopper Us and TE in LC
- Status last verified
- Jul 2023
- First submitted
- 26 May 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16416372Xia 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.
PubMed 30724863
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Doppler Ultrasound and Transient Elestoghraphy as Predictors for Presence of Gastroesophageal Varices and Variceal Bleeding in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05891184
- Acronym / sponsor ID
- Dopper Us and TE in LC
- Conditions
- Gastroesophageal Varices Hemorrhage
- Keywords
- color doppler ultrasound, transient elastography, liver cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 6 Jun 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 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
Detailed description
Liver cirrhosis incidence and prevalence have been increasing significantly over the years with varying evolutions of etiologies. It is a major cause of mortality and morbidity throughout the world, causing two million deaths per year worldwide (3.5% of all death) with 50% related to cirrhosis complications and 50% related to Hepatocellular Carcinoma and viral hepatitis infections.
Variceal bleeding is among leading causes of death in patients with liver cirrhosis and portal hypertension, In current clinical practice, evaluation of the risk of upper digestive tract bleeding is based on osephagogastroduodenoscopy. Although the occurrence of esophageal varices and the time of gastrointestinal bleeding in portal hypertension cannot be exactly predicted, there are some endoscopic and clinical signs associated with a high risk of bleeding: the size of the esophageal varices, the presence of cherry-red spots (red signs) Recent studies demonstrated that the severity of liver fibrosis, especially the presence of advanced fibrosis defined as stage F3 or F4 fibrosis, is the main driver of prognosis in cirrhosis and the main risk factor for developing not only liver-related events but also extrahepatic complications.
Liver stiffness measurement is a widely used non-invasive tool for the diagnosis of liver fibrosis and has high accuracy, and if combined with platelets count, it can be also used to identify patients at high risk for esophageal varices without the need for endoscopic screening.
Previous studies have demonstrated that liver stiffness can reflect the prognosis of patients with liver cirrhosis because it can indirectly reflect portal hypertension. Liver stiffness measured using transient elastography has been validated as a prognostic quantitative marker for the occurrence of liver-related complications, survival without liver-related death, and overall survival. However, LSM has not been well-verified in the esophageal variceal rebleeding, which is a critical event.
Recent studies indicate also that Doppler ultrasound findings of the portal system and hepatic artery could predict both the presence of varices and the risk of variceal bleeding in patient with portal hypertension and liver cirrhosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: color doppler ultrasound, transient elastography, upper endoscopythe 1st group will be patients with current or past history of variceal bleeding, |
| 2 | – | Device: color doppler ultrasound, transient elastography, upper endoscopythe 2nd group will be patients having gastroesophageal varices without variceal bleeding, |
| 3 | – | Device: color doppler ultrasound, transient elastography, upper endoscopy3ed group will be patients without gastroesophageal varices or variceal bleeding. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
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 |
|---|---|---|
| color doppler ultrasound, transient elastography, upper endoscopyAbdominal 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. | Device | 1, 2, 3 |
Primary outcome
comparing the ability of ultrasound and transient elastography in detecting presence of gastroesoghageal varices to upper endoscopy in liver cirrhosis
Time frame: baseline
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 16416372Plestina 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.
- Background: PubMed 30724863Xia 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.
- Related InfoLink provided by the sponsor.
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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.
Hanan Nafeh, professor study director
Vice president of graduate studies of Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Varices Hemorrhage, 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?
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 11 Jul 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 Reham Mamdouh, lesnce (01025242310, rehamkemaly22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the ability of ultrasound and transient elastography in detecting presence of gastroesoghageal varices to upper endoscopy in liver cirrhosis (time frame: baseline). 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 NCT05891184, which also lists 2 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 11 Jul 2023.