EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.
Primary Purpose
Liver Cirrhoses, Portal Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Esophagogastroduodenoscopy
Endoscopic ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Cirrhoses
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.
Sites / Locations
- Ecuadorian Institute of Digestive DiseasesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
EGD evaluation
EUS evaluation
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Diagnosis of portal hypertension
Portal hypertension diagnosis based on portal pressure gradient
Secondary Outcome Measures
diagnostic accuracy of esophagogastroduodenoscopy
Overall accuracy of esophagogastroduodenoscopy in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.
diagnostic accuracy of endoscopic ultrasound
Overall accuracy of endoscopc ultrasound evaluation in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.
Full Information
NCT ID
NCT04191369
First Posted
November 7, 2019
Last Updated
December 5, 2019
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
1. Study Identification
Unique Protocol Identification Number
NCT04191369
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses, Portal Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGD evaluation
Arm Type
Placebo Comparator
Arm Description
Esophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard.
Arm Title
EUS evaluation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Esophagogastroduodenoscopy
Intervention Description
Esophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard.
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoscopic ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnosis of portal hypertension
Description
Portal hypertension diagnosis based on portal pressure gradient
Time Frame
During portal pressure gradient meassurement up to 4 weeks after randomization
Secondary Outcome Measure Information:
Title
diagnostic accuracy of esophagogastroduodenoscopy
Description
Overall accuracy of esophagogastroduodenoscopy in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.
Time Frame
during esophagogastroduodenoscopy procedure up to 2 weeks after randomization
Title
diagnostic accuracy of endoscopic ultrasound
Description
Overall accuracy of endoscopc ultrasound evaluation in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.
Time Frame
during endoscopic ultrasound evaluation up yo 2 weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ecuadorian Institute of Digestive Diseases
City
Guayaquil
State/Province
Guayas
ZIP/Postal Code
090505
Country
Ecuador
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos A Robles-Medranda, MD
Phone
+593989158865
Email
carlosoakm@yahoo.es
First Name & Middle Initial & Last Name & Degree
Carlos A Robles-Medranda, MD
First Name & Middle Initial & Last Name & Degree
Roberto A Oleas, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8301060
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.
Results Reference
background
PubMed Identifier
25339809
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.
Results Reference
background
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EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.
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