- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06707298
Role of MDCT in Grading of Esophageal Varices
The Role of Multidetector Computed Tomography(MDCT) in Grading of Oesophageal Varices in Cirrhotic Patients in Comparison to Endoscopy
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
-Cirrhotic patients with portal hypertension undergoing upper GI endoscopy.
Exclusion Criteria:
-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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison between CT and endscopy in esophageal varices
Time Frame: Baseline
|
Agreement between MDCT and endoscopy in the grading of esophageal varices
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment other complication of varicesand cirrhosis in CT
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Li 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.
- Zhang 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.
- Gunda 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDCT in esophageal varices
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MDCT Esoghageal Varices
-
Shanghai Zhongshan HospitalThe First Affiliated Hospital of Nanchang University; RenJi Hospital; Qilu Hospital... and other collaboratorsNot yet recruitingPortal Hypertension | Esophageal Varices | Gastric Varices | Gastroesophageal Varices Hemorrhage
-
National Science Council, TaiwanE-DA HospitalUnknownUlcer, on Gastric Varices | Rebleeding From Gastric VaricesTaiwan
-
Second Affiliated Hospital, School of Medicine,...RecruitingEsophagogastric VaricesChina
-
Yu ChangRecruitingGastric Varices BleedingChina
-
Asian Institute of Gastroenterology, IndiaRecruitingGastric Varices BleedingIndia
-
Indiana UniversityCompleted
-
Ruijin HospitalRecruiting
-
Centre Hospitalier Universitaire VaudoisNot yet recruitingGastric Varix | Gastric Varices Bleeding
-
Unity Health TorontoWithdrawnEndoscopic Ultrasound | Gastric Varices Bleeding
-
Baxter Healthcare CorporationCompletedEsophageal and/or Gastric VaricesGermany