Esophageal VaricesNCT05485714
Non-invasive Prediction of Esophageal Varices in Patients With Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis
An observational study of Esophageal Varices and Non-alcoholic Fatty Liver, run by United Arab Emirates University at 1 site in United Arab Emirates.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is defined as accumulation of fat in the liver which is not related to either alcohol excess or other causes such viral infection, immune-mediated, or medication related which can lead to fibrosis and later-on, cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Varices, Non-alcoholic Fatty Liver, Compensated Cirrhosis
- What is being tested?
- Reviewing records retrospectively of patients undergoing screening endoscopy
- How many people
- 73 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 5 Oct 2022to 1 Aug 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with Non-alcoholic fatty liver related advanced liver fibrosis confirmed on Fibroscan (stage F3 or F4) referred to Endoscopy Unit Tawam Hospital, Al Ain Abu Dhabi for screening of esophageal varices fulfilling the above-mentioned criteria will be selected. All consecutive patients over the last five years will be selected
Who may be able to join
- Patient diagnosed to have non-alcohol fatty liver disease
- Evidence of Liver stiffness measurement of > 9.9 KPa (indicative of >F3 fibrosis ).
- Periportal hepatic fibrosis and liver echotexture changes confirmed by an experienced radiologist with expertise in Ultrasound.
- Vitally stable patients (without massive bleeding, encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, shock).
- Compensated Liver cirrhosis (no evidence of decompensation previously)
Who cannot join
- Active alcohol abuse (abstinence of alcohol for less than six months).
- Evidence of other etiology for liver cirrhosis like viral infection (HBsAg +ve or Anti-HCV seropositivity or viral DNA seen in past/present) or immune/ congenital cause of liver cirrhosis (like autoimmune, congenital hepatic fibrosis etc)
- Co-morbid liver or biliary disease (hepatoma, biliary channel obstruction).
- Evidence of band ligation/sclerotherapy, portosystemic shunting procedure or surgery for portal hypertension in the past
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Internal Medicine, College of Medicine and Health Sciences
Al Ain City, Abu Dhabi Emirate, 15551
About this study
Official title: Non-invasive Prediction of Esophageal Varices in Patients With Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis; A Single Centre United Arab Emirates Experience
Non-alcoholic fatty liver disease (NAFLD) is defined as accumulation of fat in the liver which is not related to either alcohol excess or other causes such viral infection, immune-mediated, or medication related which can lead to fibrosis and later-on, cirrhosis. Over the last years NAFLD related liver cirrhosis has become the commonest cause of chronic liver disease worldwide. Portal hypertension is the major complication caused by increased splanchnic blood flow which leads to development of oesophageal varices (OV). Almost all of the patients with portal hypertension can develop OV sometime in their life and one third of those will bleed, hence identifying the presence of OV is a an important aspect of diagnostic workup of these patients with portal hypertension.
Upper digestive camera test/endoscopy is the only means to diagnose and grade OV but endoscopy is an invasive procedure and its cost effectiveness for screening is also questionable. These limitations and the ever-increasing workload on endoscopy units has led many researchers to identify some parameters that can non-invasively diagnose OV. Researchers have proposed use of platelet count/spleen diameter ratio, liver stiffness on Fibroscan among many non-invasive tools to predict OV in patients with portal hypertension with success. Recently criteria proposed in Baveno VI conference, (Baveno-IV Criteria) recommended that screening endoscopy can be avoided in patients with compensated advanced chronic liver disease (cACLD) with liver stiffness measurement (LSM) less than 20 kPa and a platelet count more than than 150,000/μL with an expanded Baveno-IV criteria suggesting platelet count >110 × 109 cells/L and LSM <25 kPa can spare even more endoscopies with a risk of missing varices needing treatment (VNT) being minimal.
Read the detailed description
Background:
Non-alcoholic fatty liver disease (NAFLD) is defined as fatty infiltration of the liver not related to alcohol excess or other usual causes of hepatic steatosis e.g. viral or autoimmune hepatitis or secondary to medications and includes a spectrum ranging from steatosis, steatohepatitis, and fibrosis to cirrhosis; and is now the most common cause of chronic liver disease worldwide with prevalence of up to 30%. Although most patients with NAFLD may not progress to advanced fibrosis or cirrhosis, but as it has become so prevalent that still many patients develop cirrhosis and is now a leading indication for liver transplantation in Europe. In terms of global prevalence of NAFLD, it is quite high (32%) in the Middle East region. Portal hypertension is the major complication caused by increased splanchnic blood flow secondary to vasodilation and increased resistance to blood flow through periportal fibrosis which leads to development of oesophageal varices (OV). An estimated 90% of the portal hypertension patients will develop OV sometime in their life and 30% of those will bleed. Moreover 5-50% of the patients with acute variceal bleed will die within first days of the initial episode,6 hence identifying the presence of OV is a fundamental part of diagnostic workup of portal hypertension patients.
Upper digestive endoscopy is the only means to diagnose and grade OV but endoscopy is an invasive procedure and its cost effectiveness for screening is also questionable. These limitations and the ever-increasing workload on endoscopy units has led many researchers to identify some parameters that can non-invasively diagnose OV. The factor most commonly associated with varices in most of these studies was thrombocytopenia, though it lacked sensitivity and specificity. Previously researchers proposed normalizing the platelet count to ultrasonographic spleen diameter and used platelet count/spleen diameter ratio of 909 to predict OV non-invasively in patients with portal hypertension, with 100% prevalence adjusted negative predictive value, and further validation studies showed the generalisability of results. Recent criteria in Baveno-IV conference, (Baveno-IV Criteria), recommends that screening endoscopy can be avoided in patients with compensated advanced chronic liver disease (cACLD) with liver stiffness measurement (LSM) less than 20 kPa and a platelet count more than than 150,000/μL. A new expanded Baveno-IV criteria suggesting platelet count >110 × 109 cells/L and LSM <25 kPa, likely to spare even more endoscopies with a risk of missing varices needing treatment (VNT) of only 1.6% (95% confidence interval, 0.7%-3.5%) in patients within the criteria and 0.6% (95% confidence interval, 0.3%-1.4%) in the overall population of 925 patients with cACLD.
Aim:
The purpose of this study is to compare the ability of various non-invasive methods including Baveno-IV \& expanded Baveno-IV criteria, platelet count/spleen diameter, and platelet count/(spleen diameter + LSM), in prediction of VNT in NAFLD with advance liver fibrosis
Patients \& Methods:
We plan to include minimum 100 patients of NAFLD related liver fibrosis as per selection criteria
All the patients with NAFLD related liver fibrosis confirmed on Fibroscan referred to Endoscopy Unit, Tawam Hospital for screening of esophageal varices fulfilling the selection criteria will be selected from medical records and their documented demographic data and data pertaining to history of present illness and positive physical signs will be obtained. The biochemical workup (bilirubin, prothrombin time, albumin, creatinine), ultrasound for presence of ascites and bipolar splenic diameter, and data for liver stiffness measurement and results of upper GI endoscopy will be obtained. The Baveno-IV criteria and expanded Baveno-IV criteria and platelet count (in /mm3) to spleen diameter (in mm) ratio will be calculated/applied in all these patients and compared with outcomes of gold standard i.e Endoscopy results. All this information will be collected in excel sheet for further transfer on statistical software for further analysis.
- Being tested
- Reviewing records retrospectively of patients undergoing screening endoscopy
- Keywords
- Platelet count, Spleen diameter, Baveno VI, non-invasive prediction, liver Stiffness, varices needing treatment, Endoscopy
- Medical subject headings
- Esophageal and Gastric Varices, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reviewing records retrospectively of patients undergoing screening endoscopyOther
Reviewing records retrospectively of patients undergoing screening endoscopy to assess Baveno VI, expanded Baveno VI, Platelet count/spleen diameter and other non-invasive predictors of esophageal varices or varices needing treatment
| Study group | Role | What they receive |
|---|---|---|
| Patient with non-alcoholic fatty liver with advanced liver fibrosis | Patient with non-alcoholic fatty liver with advanced liver fibrosis with F3 or F4 stage on Fibroscan without any evidence of previous decompensation like ascites, jaundice or encephalopathy Receives: Other: Reviewing records retrospectively of patients undergoing screening endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing non-invasive parameters with gold standard Endoscopy in prediction of esophageal varices in patients with fatty liver with advanced fibrosis
To compare various previous known non-invasive predictors of esophageal varices and compare their ability to predict esophageal varices when compared to gold standard i.e. endoscopy.
The predictors include;
- Platelet count to ultrasonographic spleen diameter ratio ((N/mm3)/mm) of > 909 suggesting esophageal varices are unlikely
- Baveno VI criteria i.e. liver stiffness measurement (LSM) less than 20 kPa and a platelet count more than than 150,000/μL suggesting esophageal varices are unlikely 3 New expanded Baveno VI criteria i.e. platelet count >110 × 109 cells/L and LSM <25 kPa suggesting esophageal varices are unlikely
Measured: Chart review of selected patients who underwent screening endoscopy over the last 5 years; to be completed in 6 months
Secondary outcomes (1)
Assessing a new non-invasive parameters with gold standard Endoscopy in prediction of esophageal varices in patients with fatty liver with advanced fibrosis
To look at various previous suggested predictors and see if there is cut off that exists for a new predictor that involves that all three know risk factors for esophageal varices i.e. Platelet count, spleen diameter on ultrasound and liver stiffness in kPa on fibroscan in the form of novel platelet count/(spleen diameter and Liver stiffness measurement) [(N/cm3)/(cm +kpa)] and compare with with gold standard Upper GI Endoscopy to see if this tool can predict the absence of varices needing treatment in patient with fatty liver and advanced hepatic fibrosis (fibrosis stage F3 or F4) in a tertiary care hospital in Al Ain, Abu Dhabi, United Arab Emirates.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start5 Oct 2022
- Primary completion1 May 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Collaborators
- Tawam Hospital
- Responsible party
- Principal investigator, Dr Adnan Agha, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485714
- Sponsor's protocol ID
- UAEU_TWM_MF2058-2022-856
- Status last verified
- Jan 2024
- First submitted
- 1 Aug 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agha A, Anwar E, Bashir K, Savarino V, Giannini EG. External validation of the platelet count/spleen diameter ratio for the diagnosis of esophageal varices in hepatitis C virus-related cirrhosis. Dig Dis Sci. 2009 Mar;54(3):654-60. doi: 10.1007/s10620-008-0367-y. Epub 2008 Jul 2.
PubMed 18594972Agha A, Abdulhadi MM, Marenco S, Bella A, Alsaudi D, El-Haddad A, Inferrera S, Savarino V, Giannini EG. Use of the platelet count/spleen diameter ratio for the noninvasive diagnosis of esophageal varices in patients with schistosomiasis. Saudi J Gastroenterol. 2011 Sep-Oct;17(5):307-11. doi: 10.4103/1319-3767.84483.
PubMed 21912056Giannini E, Botta F, Borro P, Risso D, Romagnoli P, Fasoli A, Mele MR, Testa E, Mansi C, Savarino V, Testa R. Platelet count/spleen diameter ratio: proposal and validation of a non-invasive parameter to predict the presence of oesophageal varices in patients with liver cirrhosis. Gut. 2003 Aug;52(8):1200-5. doi: 10.1136/gut.52.8.1200.
PubMed 12865282Pizzamiglio M, Weicker A, de Terwangne C, Henrion J, Descamps OS, De Vos M. Validation of Baveno VI and Expanded-Baveno VI Criteria for predicting gastroesophageal varices in patients with alcoholic and non-alcoholic fatty liver disease. Acta Gastroenterol Belg. 2022 Apr-Jun;85(2):321-329. doi: 10.51821/88.2.9553.
PubMed 35709776
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Prediction of Esophageal Varices in Patients With Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis; A Single Centre United Arab Emirates Experience
- ClinicalTrials.gov ID
- NCT05485714
- Acronym / sponsor ID
- UAEU_TWM_MF2058-2022-856
- Keywords
- Platelet count, Spleen diameter, Baveno VI, non-invasive prediction, liver Stiffness, varices needing treatment, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Collaborators
- Tawam Hospital
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 3 Aug 2022 (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.
Non-alcoholic fatty liver disease (NAFLD) is defined as accumulation of fat in the liver which is not related to either alcohol excess or other causes such viral infection, immune-mediated, or medication related which can lead to fibrosis and later-on, cirrhosis. Over the last years NAFLD related liver cirrhosis has become the commonest cause of chronic liver disease worldwide. Portal hypertension is the major complication caused by increased splanchnic blood flow which leads to development of oesophageal varices (OV). Almost all of the patients with portal hypertension can develop OV sometime in their life and one third of those will bleed, hence identifying the presence of OV is a an important aspect of diagnostic workup of these patients with portal hypertension.
Upper digestive camera test/endoscopy is the only means to diagnose and grade OV but endoscopy is an invasive procedure and its cost effectiveness for screening is also questionable. These limitations and the ever-increasing workload on endoscopy units has led many researchers to identify some parameters that can non-invasively diagnose OV. Researchers have proposed use of platelet count/spleen diameter ratio, liver stiffness on Fibroscan among many non-invasive tools to predict OV in patients with portal hypertension with success. Recently criteria proposed in Baveno VI conference, (Baveno-IV Criteria) recommended that screening endoscopy can be avoided in patients with compensated advanced chronic liver disease (cACLD) with liver stiffness measurement (LSM) less than 20 kPa and a platelet count more than than 150,000/μL with an expanded Baveno-IV criteria suggesting platelet count >110 × 109 cells/L and LSM <25 kPa can spare even more endoscopies with a risk of missing varices needing treatment (VNT) being minimal.
Detailed description
Background:
Non-alcoholic fatty liver disease (NAFLD) is defined as fatty infiltration of the liver not related to alcohol excess or other usual causes of hepatic steatosis e.g. viral or autoimmune hepatitis or secondary to medications and includes a spectrum ranging from steatosis, steatohepatitis, and fibrosis to cirrhosis; and is now the most common cause of chronic liver disease worldwide with prevalence of up to 30%. Although most patients with NAFLD may not progress to advanced fibrosis or cirrhosis, but as it has become so prevalent that still many patients develop cirrhosis and is now a leading indication for liver transplantation in Europe. In terms of global prevalence of NAFLD, it is quite high (32%) in the Middle East region. Portal hypertension is the major complication caused by increased splanchnic blood flow secondary to vasodilation and increased resistance to blood flow through periportal fibrosis which leads to development of oesophageal varices (OV). An estimated 90% of the portal hypertension patients will develop OV sometime in their life and 30% of those will bleed. Moreover 5-50% of the patients with acute variceal bleed will die within first days of the initial episode,6 hence identifying the presence of OV is a fundamental part of diagnostic workup of portal hypertension patients.
Upper digestive endoscopy is the only means to diagnose and grade OV but endoscopy is an invasive procedure and its cost effectiveness for screening is also questionable. These limitations and the ever-increasing workload on endoscopy units has led many researchers to identify some parameters that can non-invasively diagnose OV. The factor most commonly associated with varices in most of these studies was thrombocytopenia, though it lacked sensitivity and specificity. Previously researchers proposed normalizing the platelet count to ultrasonographic spleen diameter and used platelet count/spleen diameter ratio of 909 to predict OV non-invasively in patients with portal hypertension, with 100% prevalence adjusted negative predictive value, and further validation studies showed the generalisability of results. Recent criteria in Baveno-IV conference, (Baveno-IV Criteria), recommends that screening endoscopy can be avoided in patients with compensated advanced chronic liver disease (cACLD) with liver stiffness measurement (LSM) less than 20 kPa and a platelet count more than than 150,000/μL. A new expanded Baveno-IV criteria suggesting platelet count >110 × 109 cells/L and LSM <25 kPa, likely to spare even more endoscopies with a risk of missing varices needing treatment (VNT) of only 1.6% (95% confidence interval, 0.7%-3.5%) in patients within the criteria and 0.6% (95% confidence interval, 0.3%-1.4%) in the overall population of 925 patients with cACLD.
Aim:
The purpose of this study is to compare the ability of various non-invasive methods including Baveno-IV \& expanded Baveno-IV criteria, platelet count/spleen diameter, and platelet count/(spleen diameter + LSM), in prediction of VNT in NAFLD with advance liver fibrosis
Patients \& Methods:
We plan to include minimum 100 patients of NAFLD related liver fibrosis as per selection criteria
All the patients with NAFLD related liver fibrosis confirmed on Fibroscan referred to Endoscopy Unit, Tawam Hospital for screening of esophageal varices fulfilling the selection criteria will be selected from medical records and their documented demographic data and data pertaining to history of present illness and positive physical signs will be obtained. The biochemical workup (bilirubin, prothrombin time, albumin, creatinine), ultrasound for presence of ascites and bipolar splenic diameter, and data for liver stiffness measurement and results of upper GI endoscopy will be obtained. The Baveno-IV criteria and expanded Baveno-IV criteria and platelet count (in /mm3) to spleen diameter (in mm) ratio will be calculated/applied in all these patients and compared with outcomes of gold standard i.e Endoscopy results. All this information will be collected in excel sheet for further transfer on statistical software for further analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with non-alcoholic fatty liver with advanced liver fibrosis | – | Other: Reviewing records retrospectively of patients undergoing screening endoscopyPatient with non-alcoholic fatty liver with advanced liver fibrosis with F3 or F4 stage on Fibroscan without any evidence of previous decompensation like ascites, jaundice or encephalopathy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with Non-alcoholic fatty liver related advanced liver fibrosis confirmed on Fibroscan (stage F3 or F4) referred to Endoscopy Unit Tawam Hospital, Al Ain Abu Dhabi for screening of esophageal varices fulfilling the above-mentioned criteria will be selected. All consecutive patients over the last five years will be selected
Key inclusion criteria (5 listed)
- Patient diagnosed to have non-alcohol fatty liver disease
- Evidence of Liver stiffness measurement of > 9.9 KPa (indicative of >F3 fibrosis ).
- Periportal hepatic fibrosis and liver echotexture changes confirmed by an experienced radiologist with expertise in Ultrasound.
- Vitally stable patients (without massive bleeding, encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, shock).
- Compensated Liver cirrhosis (no evidence of decompensation previously)
Key exclusion criteria (4 listed)
- Active alcohol abuse (abstinence of alcohol for less than six months).
- Evidence of other etiology for liver cirrhosis like viral infection (HBsAg +ve or Anti-HCV seropositivity or viral DNA seen in past/present) or immune/ congenital cause of liver cirrhosis (like autoimmune, congenital hepatic fibrosis etc)
- Co-morbid liver or biliary disease (hepatoma, biliary channel obstruction).
- Evidence of band ligation/sclerotherapy, portosystemic shunting procedure or surgery for portal hypertension in the past
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 |
|---|---|---|
| Reviewing records retrospectively of patients undergoing screening endoscopyReviewing records retrospectively of patients undergoing screening endoscopy to assess Baveno VI, expanded Baveno VI, Platelet count/spleen diameter and other non-invasive predictors of esophageal varices or varices needing treatment | Other | Patient with non-alcoholic fatty liver with advanced liver fibrosis |
Primary outcome
Comparing non-invasive parameters with gold standard Endoscopy in prediction of esophageal varices in patients with fatty liver with advanced fibrosis
Time frame: Chart review of selected patients who underwent screening endoscopy over the last 5 years; to be completed in 6 months
To compare various previous known non-invasive predictors of esophageal varices and compare their ability to predict esophageal varices when compared to gold standard i.e. endoscopy. The predictors include; 1. Platelet count to ultrasonographic spleen diameter ratio ((N/mm3)/mm) of > 909 suggesting esophageal varices are unlikely 2. Baveno VI criteria i.e. liver stiffness measurement (LSM) less than 20 kPa and a platelet count more than than 150,000/μL suggesting esophageal varices are unlikely 3 New expanded Baveno VI criteria i.e. platelet count >110 × 109 cells/L and LSM <25 kPa suggesting esophageal varices are unlikely
1 secondary outcome
Assessing a new non-invasive parameters with gold standard Endoscopy in prediction of esophageal varices in patients with fatty liver with advanced fibrosis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 18594972Agha A, Anwar E, Bashir K, Savarino V, Giannini EG. External validation of the platelet count/spleen diameter ratio for the diagnosis of esophageal varices in hepatitis C virus-related cirrhosis. Dig Dis Sci. 2009 Mar;54(3):654-60. doi: 10.1007/s10620-008-0367-y. Epub 2008 Jul 2.
- Background: PubMed 21912056Agha A, Abdulhadi MM, Marenco S, Bella A, Alsaudi D, El-Haddad A, Inferrera S, Savarino V, Giannini EG. Use of the platelet count/spleen diameter ratio for the noninvasive diagnosis of esophageal varices in patients with schistosomiasis. Saudi J Gastroenterol. 2011 Sep-Oct;17(5):307-11. doi: 10.4103/1319-3767.84483.
- Background: PubMed 12865282Giannini E, Botta F, Borro P, Risso D, Romagnoli P, Fasoli A, Mele MR, Testa E, Mansi C, Savarino V, Testa R. Platelet count/spleen diameter ratio: proposal and validation of a non-invasive parameter to predict the presence of oesophageal varices in patients with liver cirrhosis. Gut. 2003 Aug;52(8):1200-5. doi: 10.1136/gut.52.8.1200.
- Background: PubMed 35709776Pizzamiglio M, Weicker A, de Terwangne C, Henrion J, Descamps OS, De Vos M. Validation of Baveno VI and Expanded-Baveno VI Criteria for predicting gastroesophageal varices in patients with alcoholic and non-alcoholic fatty liver disease. Acta Gastroenterol Belg. 2022 Apr-Jun;85(2):321-329. doi: 10.51821/88.2.9553.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices and Non-alcoholic Fatty Liver, run by United Arab Emirates University at 1 site in United Arab Emirates.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing non-invasive parameters with gold standard Endoscopy in prediction of esophageal varices in patients with fatty liver with advanced fibrosis (time frame: Chart review of selected patients who underwent screening endoscopy over the last 5 years; to be completed in 6 months). 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 NCT05485714, which also lists 4 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 Jan 2024.