Clinical trial NCT06707298: Role of MDCT in Grading of Esophageal Varices
Official title: The Role of Multidetector Computed Tomography(MDCT) in Grading of Oesophageal Varices in Cirrhotic Patients in Comparison to Endoscopy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: MDCT Esoghageal Varices
Keywords: MDCT
Esophageal varices
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhotic pateints with esophageal varices with no previous history of intervention andnot contraindicated to endoscopy.

Brief 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 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 .

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison between CT and endscopy in esophageal varices
timeFrame: Baseline
Secondary outcomes:
measure: Assessment other complication of varicesand cirrhosis in CT
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.