EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.

N/AUnknownNCT04191369

Instituto Ecuatoriano de Enfermedades Digestivas35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Liver Cirrhoses

Interventions

EsophagogastroduodenoscopyDIAGNOSTIC_TEST

Esophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard.

Endoscopic ultrasoundDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Diagnosis of portal hypertension

Portal hypertension diagnosis based on portal pressure gradient

Time frame: During portal pressure gradient meassurement up to 4 weeks after randomization

Secondary Outcomes

diagnostic accuracy of esophagogastroduodenoscopy

Overall accuracy of esophagogastroduodenoscopy in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.

Time frame: 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.

Time frame: during endoscopic ultrasound evaluation up yo 2 weeks after randomization