MDCT Esoghageal VaricesNCT06707298
Role of MDCT in Grading of Esophageal Varices
An observational study of MDCT Esoghageal Varices, run by Assiut University.
Trial summary
Esophageal varices are one of the major complications of liver cirrhosis.Accurate grading of these varices is essential for effective management . Traditionally, esophagogastroduodenoscopy is the gold standard for diagnosing and grading esophageal varices,Multi detector computed tomography (MDCT) has emerged as a… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- MDCT Esoghageal Varices
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Cirrhotic pateints with esophageal varices with no previous history of intervention andnot contraindicated to endoscopy.
Who may be able to join
- -Cirrhotic patients with portal hypertension undergoing upper GI endoscopy.
Who cannot join
- -Contraindication to contrast:( severe renal insufficiency, allergy to contrast agents).
- -Previous history of upper GI endoscopy with intervention (band ligation or sclerotherapy).-
- Pregnancy.
- Patients with previous transjagular intrahepatic portosystemic shunt (TIPS).
- Patients with contraindication to endoscopy (severe cardiopulmonary conditions, coma "unless the patient is intubated", and cardiac arrhythmias)
About this study
Official title: The Role of Multidetector Computed Tomography(MDCT) in Grading of Oesophageal Varices in Cirrhotic Patients in Comparison to Endoscopy
Esophageal varices are one of the major complications of liver cirrhosis.Accurate grading of these varices is essential for effective management . Traditionally, esophagogastroduodenoscopy is the gold standard for diagnosing and grading esophageal varices,Multi detector computed tomography (MDCT) has emerged as a non-invasive alternative for evaluating esophageal varices.it particularly appealing for patients who contraindicated to endoscopy .
Read the detailed description
Esophageal varices are one of the major complications of liver cirrhosis, with an estimated prevalence of approximately 80% with decompensated patients and 50% in compensated cirrhosis, pose a significant risk of life-threatening of bleeding due to portal hypertension. Accurate grading of these varices is essential for effective management . Traditionally, esophagogastroduodenoscopy (EGD) is the gold standard for diagnosing and grading esophageal varices . IT provides direct visualization, allowing for detailed assessment of variceal size and other risk factors for bleeding . However, it is an invasive procedure that requires sedation and carries some risks, such as bleeding or perforation .
Multi detector computed tomography (MDCT) has emerged as a non-invasive alternative for evaluating esophageal varices. It offers detailed cross-sectional images and is widely available, providing a broader assessment of abdominal pathology. Its non-invasive nature makes it particularly appealing for patients who contraindicated to endoscopy .
- Conditions
- MDCT Esoghageal Varices
- Keywords
- MDCT, Esophageal varices
- Medical subject headings
- Esophageal and Gastric Varices
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between CT and endscopy in esophageal varices
Agreement between MDCT and endoscopy in the grading of esophageal varices
Measured: Baseline
Secondary outcomes (1)
Assessment other complication of varicesand cirrhosis in CT
Assessment of the presence of complications or additional findings (e.g., portal vein thrombosis,Liver pathology) and other complication related to portal hypertension as ascites or splenomegaly on MDCT.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
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 MDCT Esoghageal VaricesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Saad Wally, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707298
- Sponsor's protocol ID
- MDCT in esophageal varices
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kumar R, Nandolia KK, Sharma P, Bhadoria AS, Chauhan U, Patnaik I, Saxena S. Computed tomography virtual oesophagography for the grading of oesophageal varices in cirrhotic liver disease patients with upper gastrointestinal endoscopic examination as the gold standard: a diagnostic validation study. Pol J Radiol. 2023 Apr 5;88:e187-e193. doi: 10.5114/pjr.2023.126459. eCollection 2023.
PubMed 37234460Li J, Zhu Y, Ni J, Wang L, Lei J. Computed tomography for the diagnosis of gastroesophageal varices and risk assessment in patients with cirrhosis: a systematic review and meta-analysis. Diagn Interv Radiol. 2024 Nov 6;30(6):335-350. doi: 10.4274/dir.2024.242723. Epub 2024 May 20.
PubMed 38767277Zhang YH, Hu B. Future directions of noninvasive prediction of esophageal variceal bleeding: No worry about the present computed tomography inefficiency. World J Gastrointest Endosc. 2024 Mar 16;16(3):108-111. doi: 10.4253/wjge.v16.i3.108.
PubMed 38577650Gunda DW, Kilonzo SB, Mamballah Z, Manyiri PM, Majinge DC, Jaka H, Kidenya BR, Mazigo HD. The magnitude and correlates of esophageal Varices among newly diagnosed cirrhotic patients undergoing screening fibre optic endoscope before incident bleeding in North-Western Tanzania; a cross-sectional study. BMC Gastroenterol. 2019 Nov 29;19(1):203. doi: 10.1186/s12876-019-1123-9.
PubMed 31783802
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Multidetector Computed Tomography(MDCT) in Grading of Oesophageal Varices in Cirrhotic Patients in Comparison to Endoscopy
- ClinicalTrials.gov ID
- NCT06707298
- Acronym / sponsor ID
- MDCT in esophageal varices
- Conditions
- MDCT Esoghageal Varices
- Keywords
- MDCT, Esophageal varices
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 27 Nov 2024 (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.
Esophageal varices are one of the major complications of liver cirrhosis.Accurate grading of these varices is essential for effective management . Traditionally, esophagogastroduodenoscopy is the gold standard for diagnosing and grading esophageal varices,Multi detector computed tomography (MDCT) has emerged as a non-invasive alternative for evaluating esophageal varices.it particularly appealing for patients who contraindicated to endoscopy .
Detailed description
Esophageal varices are one of the major complications of liver cirrhosis, with an estimated prevalence of approximately 80% with decompensated patients and 50% in compensated cirrhosis, pose a significant risk of life-threatening of bleeding due to portal hypertension. Accurate grading of these varices is essential for effective management . Traditionally, esophagogastroduodenoscopy (EGD) is the gold standard for diagnosing and grading esophageal varices . IT provides direct visualization, allowing for detailed assessment of variceal size and other risk factors for bleeding . However, it is an invasive procedure that requires sedation and carries some risks, such as bleeding or perforation .
Multi detector computed tomography (MDCT) has emerged as a non-invasive alternative for evaluating esophageal varices. It offers detailed cross-sectional images and is widely available, providing a broader assessment of abdominal pathology. Its non-invasive nature makes it particularly appealing for patients who contraindicated to endoscopy .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic pateints with esophageal varices with no previous history of intervention andnot contraindicated to endoscopy.
Key inclusion criteria (1 listed)
- -Cirrhotic patients with portal hypertension undergoing upper GI endoscopy.
Key exclusion criteria (5 listed)
- -Contraindication to contrast:( severe renal insufficiency, allergy to contrast agents).
- -Previous history of upper GI endoscopy with intervention (band ligation or sclerotherapy).-
- Pregnancy.
- Patients with previous transjagular intrahepatic portosystemic shunt (TIPS).
- Patients with contraindication to endoscopy (severe cardiopulmonary conditions, coma "unless the patient is intubated", and cardiac arrhythmias)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between CT and endscopy in esophageal varices
Time frame: Baseline
Agreement between MDCT and endoscopy in the grading of esophageal varices
1 secondary outcome
Assessment other complication of varicesand cirrhosis in CT
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 37234460Kumar R, Nandolia KK, Sharma P, Bhadoria AS, Chauhan U, Patnaik I, Saxena S. Computed tomography virtual oesophagography for the grading of oesophageal varices in cirrhotic liver disease patients with upper gastrointestinal endoscopic examination as the gold standard: a diagnostic validation study. Pol J Radiol. 2023 Apr 5;88:e187-e193. doi: 10.5114/pjr.2023.126459. eCollection 2023.
- Background: PubMed 38767277Li J, Zhu Y, Ni J, Wang L, Lei J. Computed tomography for the diagnosis of gastroesophageal varices and risk assessment in patients with cirrhosis: a systematic review and meta-analysis. Diagn Interv Radiol. 2024 Nov 6;30(6):335-350. doi: 10.4274/dir.2024.242723. Epub 2024 May 20.
- Background: PubMed 38577650Zhang YH, Hu B. Future directions of noninvasive prediction of esophageal variceal bleeding: No worry about the present computed tomography inefficiency. World J Gastrointest Endosc. 2024 Mar 16;16(3):108-111. doi: 10.4253/wjge.v16.i3.108.
- Background: PubMed 31783802Gunda DW, Kilonzo SB, Mamballah Z, Manyiri PM, Majinge DC, Jaka H, Kidenya BR, Mazigo HD. The magnitude and correlates of esophageal Varices among newly diagnosed cirrhotic patients undergoing screening fibre optic endoscope before incident bleeding in North-Western Tanzania; a cross-sectional study. BMC Gastroenterol. 2019 Nov 29;19(1):203. doi: 10.1186/s12876-019-1123-9.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of MDCT Esoghageal Varices, 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?
The sponsor lists 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Comparison between CT and endscopy in esophageal varices (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 NCT06707298, 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 27 Nov 2024.