EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.

Instituto Ecuatoriano de Enfermedades Digestivas

Status: Unknown

Conditions: Liver Cirrhoses; Portal Hypertension

Treatments: Diagnostic Test: Endoscopic ultrasound; Diagnostic Test: Esophagogastroduodenoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04191369

EUS-EGD-PH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

EGD evaluation

Placebo Comparator group

Description:

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

Treatment:

Diagnostic Test: Esophagogastroduodenoscopy

EUS evaluation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Endoscopic ultrasound