Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-05 @ 5:36 PM
Study NCT ID:
NCT04191369
Status:
UNKNOWN
Last Update Posted:
2019-12-09
First Post:
2019-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D019160', 'term': 'Endosonography'}], 'ancestors': [{'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of portal hypertension', 'timeFrame': 'During portal pressure gradient meassurement up to 4 weeks after randomization', 'description': 'Portal hypertension diagnosis based on portal pressure gradient'}], 'secondaryOutcomes': [{'measure': 'diagnostic accuracy of esophagogastroduodenoscopy', 'timeFrame': 'during esophagogastroduodenoscopy procedure up to 2 weeks after randomization', 'description': 'Overall accuracy of esophagogastroduodenoscopy in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.'}, {'measure': 'diagnostic accuracy of endoscopic ultrasound', 'timeFrame': 'during endoscopic ultrasound evaluation up yo 2 weeks after randomization', 'description': 'Overall accuracy of endoscopc ultrasound evaluation in the detection and grading of esophageal varices, gastric varices and hypertensive gastropathy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhoses', 'Portal Hypertension']}, 'referencesModule': {'references': [{'pmid': '8301060', 'type': 'BACKGROUND', '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.'}, {'pmid': '25339809', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Liver cirrhosis with the further development of portal hypertension implies structural and vasculature alteration in the portosplenic circulation.\n\nEsophagogastroduodenoscopy 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.\n\nEndoscopic 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.\n\nThe investigators aimed to compare esophagogastroduodenoscopy versus endoscopic ultrasound evaluation for the early diagnosis of portal hypertension in cirrhotic patients.', 'detailedDescription': '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.\n\nThe portal pressure gradient will be defined based on portal vein catheterization via interventional radiology.\n\nEsophagogastroduodenoscopy will evaluate the presence and grade of esophageal varices, presence and type of gastric varices, presence and signs of hypertensive gastropathy.\n\nEndoscopic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years old\n* Willingness to participate in the study\n* Compensated liver cirrhosis based on clinical and imaging findings\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis: ascitis, encephalopathy, gastrointestinal bleeding, infection\n* Hemodynamic instability\n* Pregant or nursing patients\n* Patients with history of esophageal, gastric, liver, pancreas and spleen tumors\n* Severe uncontrolled coagulopathy\n* Any contraindication for portal pressure gradient meassurement via radiological evaluation.'}, 'identificationModule': {'nctId': 'NCT04191369', 'briefTitle': 'EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Ecuatoriano de Enfermedades Digestivas'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Endoscopic Ultrasound Evaluation Versus Esophagogastroduodenoscopy in the Diagnosis of Portal Hypertension in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'EUS-EGD-PH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'EGD evaluation', '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.', 'interventionNames': ['Diagnostic Test: Esophagogastroduodenoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'EUS evaluation', '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.\n\nPortal pressure gradient will be evaluated via interventional radiology as gold standard.', 'interventionNames': ['Diagnostic Test: Endoscopic ultrasound']}], 'interventions': [{'name': 'Esophagogastroduodenoscopy', 'type': 'DIAGNOSTIC_TEST', '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.', 'armGroupLabels': ['EGD evaluation']}, {'name': 'Endoscopic ultrasound', 'type': 'DIAGNOSTIC_TEST', '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.\n\nPortal pressure gradient will be evaluated via interventional radiology as gold standard.', 'armGroupLabels': ['EUS evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '090505', 'city': 'Guayaquil', 'state': 'Guayas', 'status': 'RECRUITING', 'country': 'Ecuador', 'contacts': [{'name': 'Carlos A Robles-Medranda, MD', 'role': 'CONTACT', 'email': 'carlosoakm@yahoo.es', 'phone': '+593989158865'}, {'name': 'Carlos A Robles-Medranda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roberto A Oleas, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ecuadorian Institute of Digestive Diseases', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Ecuatoriano de Enfermedades Digestivas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}