Role of MDCT in Grading of Esophageal Varices | NCT06707298

Studies
Role of MDCT in Grading of Esophageal Varices

NCT06707298

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Nov 27, 2024Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

MDCT Esoghageal Varices

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2024Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Nov 24, 2024

First Submission Date that Met QC Criteria

Nov 24, 2024

First Posted Date

Nov 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2024

Last Update Posted Date

Nov 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between CT and endscopy in esophageal varices	Agreement between MDCT and endoscopy in the grading of esophageal varices	Baseline

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Cirrhotic pateints with esophageal varices with no previous history of intervention andnot contraindicated to endoscopy.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37234460	Background	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.
38767277

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006975	Hypertension, Portal