EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.

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.

Full Title of Study: “A Randomized Controlled Trial Comparing Endoscopic Ultrasound Evaluation Versus Esophagogastroduodenoscopy in the Diagnosis of Portal Hypertension in Cirrhotic Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: November 1, 2020

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 Test: 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.
  • Diagnostic Test: 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.

Arms, Groups and Cohorts

  • Placebo Comparator: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Diagnosis of portal hypertension
    • Time Frame: During portal pressure gradient meassurement up to 4 weeks after randomization
    • Portal hypertension diagnosis based on portal pressure gradient

Secondary Measures

  • diagnostic accuracy of esophagogastroduodenoscopy
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto Ecuatoriano de Enfermedades Digestivas
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

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