Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-28 @ 8:59 AM
Study NCT ID:
NCT02115061
Status:
UNKNOWN
Last Update Posted:
2014-04-15
First Post:
2014-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-11', 'studyFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2014-04-11', 'lastUpdatePostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the results of the treatment of gastric varices, gastric varices treatment coil and cyanocrylate versus cyanocrylate in 28 patients with systemic shunts in relation to efficacy and embolic complications.', 'timeFrame': 'Four months after patient recruitment.', 'description': 'Patient recruitment, the signing of the terms and data collection will be carried out between September 2012 and August 2014. Data analysis and statistical studies between September and October 2014. The scheduled date for completion of the study is the December 2014.\n\nThe monitoring will be performed with endoscopy and endoscopic ultrasound at 1, 4 and 10 months after the procedure. Analyzed the recurrence and clinical outcome, with completion of new questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric varices,coil,cyanoacrylate,treating gastric varices.'], 'conditions': ['Gastric Varices']}, 'descriptionModule': {'briefSummary': 'The purpose of the spring is to maintain the cyanoacrylate polymer of the gastric varix, forming a conglomerate spring-cyanoacrylate, and thus preventing their migration to the adhesive embolism.\n\nThe introduction of the spring is held by a echo-guided puncture. The window can be puncture through the distal esophagus or directly in the gastric varix via retroflexion to the fundus. Another advantage of this technique is its use in the presence of bleeding, when large amounts of blood in the stomach hinders the injection of the cyanoacrylate, by pricking the distal esophagus that difficulty decreases. The first study of this technique was performed by Binmoeller et al (21) and had good results with 100% hemostasis and low rebleeding rate (16%), but more studies are needed to prove the safety and efficacy of this technique.', 'detailedDescription': 'OBJECTIVE Compare the results of the treatment of gastric varices, coil associated with cianoarilato versus cyanoacrylate in patients with systemic shunts in relation to efficacy and embolic complications.\n\nPATIENTS, MATERIALS AND METHODS Drawing\n\nThis is a prospective clinical trial, double-blind, comparative, randomized, single center, performed on quaternary level hospital involving patients with portal hypertension with gastric varices type 2 GOV or IGV 1.\n\n28 cirrhotic patients will be randomized to the treatment of gastric varices type GOV2 IGV1 or more cyanoacrylate Cyanoacrylate or only patients with splenorenal shunt or gastrorenal spring.\n\nAfter signing the consent form, patients will undergo CT angiography to evaluate the presence of shunt and classification of the same. Patients without shunt will be excluded from the protocol.\n\nDopller colored portal system will also be conducted in all patients prior to treatment for analysis of portal flow.\n\nAfter confirming the presence of shunt patients will be examined by echo-endoscopy for completion of treatment The following data will be collected: demographic data (age and gender), etiology of cirrhosis, degree of liver function, primary or secondary prophylaxis diameter of gastric varix, varices of the esophagus with or without signs of red color, size and type of shunt detected by CT, amount of springs inserted, number of ampoules of Cyanoacrylate injected complications (bleeding, damage to the endoscope by cyanoacrylate)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with portal hypertension and pseudo-tumor gastric varices type IGV1 or GOV2 and presence of gastrorenal or splenorenal shunt.\n\nExclusion Criteria:\n\n* Refusal of the patient or their legal guardian.'}, 'identificationModule': {'nctId': 'NCT02115061', 'briefTitle': 'Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate', 'orgStudyIdInfo': {'id': '02621613100000068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyanoacrylate', 'description': 'This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate.\n\nTreatment: cyanoacrylate', 'interventionNames': ['Device: Treatment: cyanoacrylate']}, {'type': 'SHAM_COMPARATOR', 'label': 'Coil + cyanocrylate', 'description': 'This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate.\n\nTreatment: coil + cyanoacrylate', 'interventionNames': ['Device: Treatment: coil + cyanoacrylate']}], 'interventions': [{'name': 'Treatment: coil + cyanoacrylate', 'type': 'DEVICE', 'otherNames': ['Coil + cyanoacrylate'], 'description': 'This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate.', 'armGroupLabels': ['Coil + cyanocrylate']}, {'name': 'Treatment: cyanoacrylate', 'type': 'DEVICE', 'otherNames': ['Cyanoacrylate'], 'description': 'This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate.', 'armGroupLabels': ['Cyanoacrylate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Maíra R de Almeida', 'role': 'CONTACT', 'email': 'mairaralmeida@hotmail.com', 'phone': '55-11-26619577'}], 'facility': 'Hospital das Clínicas da FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Ana C Cândido', 'role': 'CONTACT', 'email': 'ana.candido@hc.fm.usp.br', 'phone': '55-11-26619577'}, {'name': 'Maíra R de Almeida', 'role': 'CONTACT', 'email': 'mairaralmeida@hotmail.com', 'phone': '55-11-26617579'}], 'overallOfficials': [{'name': 'Maíra R de Almeida', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital das Clínicas da FMUSP'}, {'name': 'Dalton Chaves', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital das Clínicas FMUSP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}