EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.
NCT ID: NCT04191369
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2019-11-01
2020-11-30
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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EGD evaluation
Esophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard.
Esophagogastroduodenoscopy
Esophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard.
EUS evaluation
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.
Endoscopic 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.
Interventions
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Esophagogastroduodenoscopy
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 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.
Eligibility Criteria
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Inclusion Criteria
* Willingness to participate in the study
* Compensated liver cirrhosis based on clinical and imaging findings
* Written informed consent provided
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Instituto Ecuatoriano de Enfermedades Digestivas
OTHER
Responsible Party
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Locations
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Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, Ecuador
Countries
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Facility Contacts
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Carlos A Robles-Medranda, MD
Role: primary
References
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Boustiere C, Dumas O, Jouffre C, Letard JC, Patouillard B, Etaix JP, Barthelemy C, Audigier JC. Endoscopic ultrasonography classification of gastric varices in patients with cirrhosis. Comparison with endoscopic findings. J Hepatol. 1993 Sep;19(2):268-72. doi: 10.1016/s0168-8278(05)80581-1.
Hammoud GM, Ibdah JA. Utility of endoscopic ultrasound in patients with portal hypertension. World J Gastroenterol. 2014 Oct 21;20(39):14230-6. doi: 10.3748/wjg.v20.i39.14230.
Other Identifiers
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EUS-EGD-PH
Identifier Type: -
Identifier Source: org_study_id