Liver Cirrhoses, Portal Hypertension
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTEsophagogastroduodenoscopy
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_TESTEndoscopic ultrasound
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.
Sponsors
Instituto Ecuatoriano de Enfermedades Digestivas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of portal hypertension | During portal pressure gradient meassurement up to 4 weeks after randomization | Portal hypertension diagnosis based on portal pressure gradient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accuracy of esophagogastroduodenoscopy | during esophagogastroduodenoscopy procedure up to 2 weeks after randomization | Overall accuracy of esophagogastroduodenoscopy in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy. |
| diagnostic accuracy of endoscopic ultrasound | during endoscopic ultrasound evaluation up yo 2 weeks after randomization | Overall accuracy of endoscopc ultrasound evaluation in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy. |
Countries
Ecuador
Outcome results
None listed