EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.

Portal Hypertension Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Endoscopic Ultrasound Evaluation Versus Esophagogastroduodenoscopy in the Diagnosis of Portal Hypertension in Cirrhotic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191369
• Other study ID #: EUS-EGD-PH
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2019
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: November 30, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Cirrhoses
• Liver Cirrhosis
• Portal Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ecuador	Ecuadorian Institute of Digestive Diseases	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (2)

Boustière C, Dumas O, Jouffre C, Letard JC, Patouillard B, Etaix JP, Barthélémy 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of portal hypertension	Portal hypertension diagnosis based on portal pressure gradient	During portal pressure gradient meassurement up to 4 weeks after randomization
Secondary	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
Secondary	diagnostic accuracy of endoscopic ultrasound	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