Liver CirrhosesNCT04191369
EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.
A study testing Esophagogastroduodenoscopy and Endoscopic ultrasound in people with Liver Cirrhoses and Portal Hypertension, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhoses, Portal Hypertension
- What is being tested?
- Esophagogastroduodenoscopy and Endoscopic ultrasound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Nov 2019to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old
- Willingness to participate in the study
- Compensated liver cirrhosis based on clinical and imaging findings
- Written informed consent provided
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, 090505
Carlos A Robles-Medranda, MD, +593989158865, carlosoakm@yahoo.es
Carlos A Robles-Medranda, MD
About this study
Official title: A Randomized Controlled Trial Comparing Endoscopic Ultrasound Evaluation Versus Esophagogastroduodenoscopy in the Diagnosis of Portal Hypertension in Cirrhotic Patients
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.
Read more
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.
Read the 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.
- Conditions
- Liver Cirrhoses, Portal Hypertension
- Being tested
- Esophagogastroduodenoscopy, Endoscopic ultrasound
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogastroduodenoscopyDiagnostic 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.
Endoscopic ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Endoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of portal hypertension
Portal hypertension diagnosis based on portal pressure gradient
Measured: During portal pressure gradient meassurement up to 4 weeks after randomization
Secondary outcomes (2)
diagnostic accuracy of esophagogastroduodenoscopy
Overall accuracy of esophagogastroduodenoscopy in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.
Measured: during esophagogastroduodenoscopy procedure up to 2 weeks after randomization
diagnostic accuracy of endoscopic ultrasound
Overall accuracy of endoscopc ultrasound evaluation in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.
Measured: during endoscopic ultrasound evaluation up yo 2 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Nov 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191369
- Sponsor's protocol ID
- EUS-EGD-PH
- Status last verified
- Dec 2019
- First submitted
- 7 Nov 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8301060Hammoud 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.
PubMed 25339809
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Endoscopic Ultrasound Evaluation Versus Esophagogastroduodenoscopy in the Diagnosis of Portal Hypertension in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04191369
- Acronym / sponsor ID
- EUS-EGD-PH
- Conditions
- Liver Cirrhoses, Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EGD evaluation | Placebo comparator | Diagnostic Test: EsophagogastroduodenoscopyEsophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard. |
| EUS evaluation | Experimental | Diagnostic Test: Endoscopic ultrasoundEndoscopic 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 18 years old
- Willingness to participate in the study
- Compensated liver cirrhosis based on clinical and imaging findings
- Written informed consent provided
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagogastroduodenoscopyEsophogagastroduodenoscopy 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 | EGD evaluation |
| Endoscopic ultrasoundEndoscopic 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 | EUS evaluation |
Primary outcome
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
2 secondary outcomes
diagnostic accuracy of esophagogastroduodenoscopy
Time frame: during esophagogastroduodenoscopy procedure up to 2 weeks after randomization
diagnostic accuracy of endoscopic ultrasound
Time frame: during endoscopic ultrasound evaluation up yo 2 weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 8301060Boustiere 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.
- Background: PubMed 25339809Hammoud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagogastroduodenoscopy and Endoscopic ultrasound in people with Liver Cirrhoses and Portal Hypertension, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of portal hypertension (time frame: During portal pressure gradient meassurement up to 4 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191369, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.