Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 6:30 PM
Study NCT ID:
NCT04075760
Status:
UNKNOWN
Last Update Posted:
2019-10-10
First Post:
2019-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}], 'ancestors': [{'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Endoscopic performing EUS evaluation on follow-up will be masked to initial patient allocation'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial, parallel location , 1:1 allocation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding rate secondary to gastric varices', 'timeFrame': '12 months', 'description': 'Number of patients with melena or hematemesis accompanied by Hemoglobin drop \\> 2g/dL'}, {'measure': 'Mortality secondary to gastrointestinal bleeding', 'timeFrame': '12 months', 'description': 'mortality rate'}], 'secondaryOutcomes': [{'measure': 'Number of reinterventions', 'timeFrame': '12 months', 'description': 'number of endoscopic or endoscopic ultrasound procedures requiered for the management of gastri varices'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Varix', 'Cirrhosis', 'GastroIntestinal Bleeding']}, 'referencesModule': {'references': [{'pmid': '21145834', 'type': 'RESULT', 'citation': 'Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.', 'detailedDescription': 'Gastric variceal bleeding is a severe condition associated with a high mortality. Bleeding from varices bleeding will be defined as the occurrence of hematemesis and/or melena requiring \\>2 U of blood or a decrease of 2 gm/dl of hemoglobin if no blood transfusion is given, with the confirmed endocopic visualization of GOV II and IGV I.\n\nThe beta blocker therapy is an effective method for the prevention of the first esophageal variceal bleeding; however, the efficacy in preventing first gastric variceal bleeding is controversial.\n\nThe investigators aimed to compare the efficacy in preventing the first gastric variceal bleeding in patients with documented GOV II and IGV I.'}, '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* Writeen informed consent provided.\n* Proven GV (GOV II or IGV I) on esophagogastroduodenoscopy and EUS.\n* Gastric varices with high-risk of bleeding (large diameter, high MELD score, presence of portal hypertensive gastropathy)\n* Patient preference for EUS-guided therapy.\n\nExclusion Criteria:\n\n* Under 18 years old.\n* Refuse to sign written informed consent.\n* Pregnancy or nursing.\n* Previous treatment of gastric varices.\n* Non-cirrhotic portal hypertension\n* Concurrent hepato-renal syndrome and/or multi-organ failure.\n* Proven malignancy including hepatocellular carcinoma\n* Platelet count less than 50,000/ml or International Normalized Rate (INR) \\>2.\n* Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.\n* Esophageal stricture.\n* Uncontrolled coagulopathy.'}, 'identificationModule': {'nctId': 'NCT04075760', 'briefTitle': 'EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Ecuatoriano de Enfermedades Digestivas'}, 'officialTitle': 'EUS-guided Combined Therapy of Coiling and 2-octyl-cyanoacrylate Injection With Beta Blocker Therapy Versus Beta Blocker Alone for the Primary Prophylaxis of GOV II and IGV I', 'orgStudyIdInfo': {'id': 'EUS-PP-GV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EUS-guided combined therapy', 'description': 'Patients with endoscopic and EUS documented GOV II and IGV I will be included. Procedure will be performed under general anesthesia using a linear array therapeuthic echoendoscope, coils and cyanoacrylate will be injected within the feeder vessel under EUS and fluroscopic guidance.', 'interventionNames': ['Procedure: Coils + Cyanoacrylate Group + beta-blocker']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Beta Blocker (Propranolol)', 'description': 'o Beta-blocker (propranolol) will be started at dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose will be increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was \\> 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure \\< 90 mm Hg or pulse rate \\< 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication will be attempted if cessation of the medication did not result in improvement of the reported side-effect.', 'interventionNames': ['Drug: beta blocker therapy']}], 'interventions': [{'name': 'Coils + Cyanoacrylate Group + beta-blocker', 'type': 'PROCEDURE', 'description': 'EUS-combined coiling and cyanoacrylate injection into the feeder vessel of GOV II and IGV I\n\nPatients with Gastric Varices GOV II or IGV I that have never bleed and are of high-risk GV according to Baveno VI consensus will be prophylactically obliterated via the EUS-guided coiling and cyanoacrylate injection. Patients will also be on beta-blocker therapy as indicated in the other group.', 'armGroupLabels': ['EUS-guided combined therapy']}, {'name': 'beta blocker therapy', 'type': 'DRUG', 'description': 'A beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was \\> 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure \\< 90 mm Hg or pulse rate \\< 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.', 'armGroupLabels': ['Beta Blocker (Propranolol)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '090505', 'city': 'Guayaquil', 'state': 'Guayas', 'status': 'RECRUITING', 'country': 'Ecuador', 'contacts': [{'name': 'Carlos Robles-Medranda, M.D.', 'role': 'CONTACT', 'email': 'carlosoakm@yahoo.es', 'phone': '593-042109180'}], 'facility': 'Instituto Ecuatoriano de Enfermedades Digestivas', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}], 'centralContacts': [{'name': 'Carlos Robles-Medranda, M.D.', 'role': 'CONTACT', 'email': 'carlosoakm@yahoo.es', 'phone': '+593-042109180'}, {'name': 'Roberto Oleas, M.D.', 'role': 'CONTACT', 'email': 'robertoleas@gmail.com', 'phone': '+593-042109180'}], 'overallOfficials': [{'name': 'Carlos Robles-Medranda, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Ecuatoriano de Enfermedades Digestivas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}