EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.

NCT04191369 | Unknown DMC

• 1 other identifier: EUS-EGD-PH
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhoses; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Diagnosis of portal hypertension

  Portal hypertension diagnosis based on portal pressure gradient

  During portal pressure gradient meassurement up to 4 weeks after randomization

Secondary Outcomes (2)

• diagnostic accuracy of esophagogastroduodenoscopy

  during esophagogastroduodenoscopy procedure up to 2 weeks after randomization

• diagnostic accuracy of endoscopic ultrasound

  during endoscopic ultrasound evaluation up yo 2 weeks after randomization

Study Arms (2)

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.

Diagnostic Test: Esophagogastroduodenoscopy

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.

Diagnostic Test: Endoscopic ultrasound

Interventions

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.

EGD evaluation

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.

EUS evaluation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 18 years old
• Willingness to participate in the study
• Compensated liver cirrhosis based on clinical and imaging findings
• Written informed consent provided

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

RECRUITING

Related Publications (2)

• 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.

  PMID: 8301060 BACKGROUND

• 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.

  PMID: 25339809 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Endoscopy, Digestive System; Endosonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Ultrasonography; Diagnostic Imaging

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: December 9, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 30, 2020
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)