EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.

Study Overview
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Brief Summary
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Liver cirrhosis with the further development of portal hypertension implies structural and vasculature alteration in the portosplenic circulation. Esophagogastroduodenoscopy is the standard of care for the detection and treatment of esophageal varices, as esophageal varices serve as a surrogate for estimating a portal pressure gradient > 10 mmHG. Endoscopic ultrasound evaluation allows the detection of peri-esophageal collateral veins, perforating veins and para-esophageal collateral veins, which has demonstrated to be effective for the prediction of esophageal varices recurrence after variceal eradication. The investigators aimed to compare esophagogastroduodenoscopy versus endoscopic ultrasound evaluation for the early diagnosis of portal hypertension in cirrhotic patients.

Detailed Description
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A randomized control trial of 70 cirrhotic patients randomly submitted for esophagogastroduodenoscopy (35 patients) or EUS evaluation (35 patients) for the diagnosis of portal hypertension. The portal pressure gradient will be defined based on portal vein catheterization via interventional radiology. Esophagogastroduodenoscopy will evaluate the presence and grade of esophageal varices, presence and type of gastric varices, presence and signs of hypertensive gastropathy. Endoscopic ultrasound will evaluate the presence of esophageal varices, the presence of gastric varices and the EUS- signs og hypertensive gastropathy, Azygos vein diameter, mean velocity and blood flow volume index.

Official Title
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A Randomized Controlled Trial Comparing Endoscopic Ultrasound Evaluation Versus Esophagogastroduodenoscopy in the Diagnosis of Portal Hypertension in Cirrhotic Patients

Conditions
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Liver Cirrhoses, Portal Hypertension

Intervention / Treatment
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* Diagnostic Test: Esophagogastroduodenoscopy
* Diagnostic Test: Endoscopic ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 18 years old Willingness to participate in the study Compensated liver cirrhosis based on clinical and imaging findings Written informed consent provided Exclusion Criteria: Decompensated liver cirrhosis: ascitis, encephalopathy, gastrointestinal bleeding, infection Hemodynamic instability Pregant or nursing patients Patients with history of esophageal, gastric, liver, pancreas and spleen tumors Severe uncontrolled coagulopathy Any contraindication for portal pressure gradient meassurement via radiological evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: EGD evaluation<br>Esophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard. | Diagnostic Test: Esophagogastroduodenoscopy<br>* Esophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard.<br>|
| Experimental: EUS evaluation<br>Endoscopic ultrasound evaluation for the presence of esophageal varices, peri and para-esophageal collateral veins, gastric varices, portal hypertensive gastropathy, azygos vein diameter, blood flow and BFVI. Portal pressure gradient will be evaluated via interventional radiology as gold standard. | Diagnostic Test: Endoscopic ultrasound<br>* Endoscopic ultrasound evaluation for the presence of esophageal varices, peri and para-esophageal collateral veins, gastric varices, portal hypertensive gastropathy, azygos vein diameter, blood flow and BFVI. Portal pressure gradient will be evaluated via interventional radiology as gold standard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of portal hypertension | Portal hypertension diagnosis based on portal pressure gradient | During portal pressure gradient meassurement up to 4 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of esophagogastroduodenoscopy | Overall accuracy of esophagogastroduodenoscopy in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy. | during esophagogastroduodenoscopy procedure up to 2 weeks after randomization | 
| diagnostic accuracy of endoscopic ultrasound | Overall accuracy of endoscopc ultrasound evaluation in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy. | during endoscopic ultrasound evaluation up yo 2 weeks after randomization |