Clinical trial NCT04191369: EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.
Official title: A Randomized Controlled Trial Comparing Endoscopic Ultrasound Evaluation Versus Esophagogastroduodenoscopy in the Diagnosis of Portal Hypertension in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhoses
Portal Hypertension
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnosis of portal hypertension
timeFrame: During portal pressure gradient meassurement up to 4 weeks after randomization
Secondary outcomes:
measure: diagnostic accuracy of esophagogastroduodenoscopy
timeFrame: during esophagogastroduodenoscopy procedure up to 2 weeks after randomization
measure: diagnostic accuracy of endoscopic ultrasound
timeFrame: during endoscopic ultrasound evaluation up yo 2 weeks after randomization
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Ecuadorian Institute of Digestive Diseases
state: Guayas
Study officials:
References:
citation: 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.
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.