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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGD evaluation | Placebo Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagogastroduodenoscopy | Diagnostic 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ecuadorian Institute of Digestive Diseases | Recruiting | Guayaquil | Guayas | 090505 | Ecuador |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8301060 | Background | 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. | |
| 25339809 | Background |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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Randomized controlled trial
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| Endoscopic ultrasound | Diagnostic 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. |
|
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 |
| 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. |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |