Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT03853720
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2019-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric varice eradication following intervention (at 4 weeks)', 'timeFrame': '4 weeks', 'description': 'Gastric varice eradication following intervention (at 4 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)'}], 'secondaryOutcomes': [{'measure': 'Gastric varice eradication following intervention', 'timeFrame': '12 weeks', 'description': 'Gastric varice eradication following intervention (at 12 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)'}, {'measure': 'Recurrence of gastric varices', 'timeFrame': '4 weeks', 'description': 'Recurrence of gastric varices (defined as recurrence of gastric varices after complete eradication (at 4 weeks))'}, {'measure': 'Bleeding rates following procedure', 'timeFrame': '2 years', 'description': 'Bleeding rates following procedure (% of patients that had a bleeding at 2 years of follow-up following eradication and mean time to bleeding after procedure)'}, {'measure': 'Effect of procedure on esophageal varices', 'timeFrame': '2 years', 'description': 'Effect of procedure on esophageal varices. Classification of "Paquet" with evaluation before procedure and at 2 years after procedure (Paquet Grade 1 to 4)'}, {'measure': 'Effect of procedure on portal pressures', 'timeFrame': '3 months', 'description': 'Effect of procedure on portal pressures at 3 months assessed by endovascular hepatic pressure measurment (and compared with pressure before procedure).'}, {'measure': 'Effect of procedure on liver function', 'timeFrame': '2 years', 'description': 'Effect of procedure on liver function and cirrhosis assessed by CHILD-PUGH score ((albumin (g/l) : \\>35 = 1 point ; 28-35 = 2 points ; \\<28 = 3 points); (total bilirubin (umol/l)\\<34 = 1 point ; 34-50 = 2 points; \\>50 = 3 points); (INR : \\<1.7 = 1 point; 1.71-2.30 = 2 points; \\>2.30 = 3 points), (Ascites: none = 1 point; mild = 2 points, moderate/severe= 3 points); (Hepatic Encephalopathy: none = 1 point; Grade I-II = 2 points; Grade III-IV = 3 points). Total score : 5-6 = A ; 7-9 = B; 10-15 = C.'}, {'measure': 'Description of procedural complications', 'timeFrame': '2 years', 'description': 'Description of procedural complications (bleeding, pulmonary embolism)'}, {'measure': 'Description of pre-treatment variceal anatomy/classification', 'timeFrame': '1 day', 'description': 'Description of pre-treatment variceal anatomy/classification according to Sarin Classification'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Varices Bleeding', 'Gastric Varix']}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with balloon occluded-retrograde transvenous obliteration (B-RTO) for the treatment of high-risk gastric varices', 'detailedDescription': 'Although less frequent than esophageal varices, gastric varices constitute a severe and potentially life threatening complication of portal hypertension. Various methods have been described to treat gastric varices, including endoscopic and interventional radiology techniques. Endoscopic variceal obliteration (EVO) is currently considered as standard of care for the treatment of gastric varices in most centers. However, this technique is associated with significant rebleeding rates and incomplete obliteration is observed in about 50% of patients. Alternatively, few centers also use an interventional radiology technique, called balloon-occluded retrograde transvenous obliteration (B-RTO) to treat gastric varices, which has been shown to be associated with less recurrence of gastric varices and high rates of eradication of about 90%. Both techniques have their inherent weaknesses, such as frequent incomplete eradication of varices and thromboembolic events for EVO, while data suggest that B-RTO may aggravate esophageal varices.\n\nThe aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with (modified) B-RTO. Stopping the outflow of gastric varices by endovascular balloon occlusion may allow better endoscopic visualization, blood stagnation and thus eradication of varices, while preventing thromboembolic events. Furthermore, during study follow-up, the eradication rates and recurrence of varices, short-term and long term complications, effects of the procedure on portal pressures/hemodynamics and liver function will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed Consent as documented by signature (Appendix "Fiche d\'information aux patients et formulaire de consentement éclairé")\n2. Patients with endoscopically proven high-risk (diameter \\>2 cm, mosaic gastropathy, red spots or signs of previous bleeding) and GOV2, IGV1 and IGV2 type of gastric varices (according to Sarin classification)\n3. Portal hypertension secondary to cirrhosis\n4. Age \\>18\n\nExclusion Criteria:\n\n1. Acute gastric or esophageal varice bleeding\n2. GOV1 varices according to Sarin classification\n3. Hemodynamic instability\n4. Uncompensated cirrhosis\n5. Contraindication to general anesthesia\n6. Contraindication to CT-scan/angiography (impaired kidney function, allergy to iodine based contrast)\n7. Allergy to cyanoacrylate, drugs or material used during procedures\n8. Absence of gastro-renal shunt\n9. Pregnancy\n10. Participation to another study involving ionizing radiation (dose superior to 5mSV) without direct benefice for patient during the 12 last months'}, 'identificationModule': {'nctId': 'NCT03853720', 'acronym': 'BeRTO', 'briefTitle': 'Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'A Pilot Study Evaluating Efficacy and Safety of Combined and Simultaneous Balloon-occluded Retrograde Transvenous and Endoscopic Obliteration of High-risk Gastric Varices', 'orgStudyIdInfo': {'id': '2018-02183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'combined and simultaneous balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices', 'interventionNames': ['Procedure: balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices']}], 'interventions': [{'name': 'balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices', 'type': 'PROCEDURE', 'description': 'Catheterization of the left renal vein and the inferior diaphragmatic vein and occlusion with a balloon placed in the distal portion of this vein.\n\nEndoscopic access to the gastric cavity, gastric varices identification and flow measurement, including velocity, by endoscopic Doppler ultrasound (US). The balloon in the draining vein will be inflated and the velocity will be reassessed. Endoscopic puncture of the varices will be done and the embolization will be conducted under balloon-occlusive conditions (Injection of Cyanoacrylate: Lipiodol mixture 1:1 slowly and gradually). Balloon will be kept inflated and a microcatheter will be used through its lumen inside the variceal bed to inject occlusive agent (cyanoacrylate) mixed with Lipiodol.\n\nAt the end of the procedure an occlusion device (plug amplatzer 2) will be placed.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alban Denys, MD', 'role': 'CONTACT', 'email': 'alban.denys@chuv.ch', 'phone': '0041213149768'}, {'name': 'Nils Degrauwe, MD-PhD', 'role': 'CONTACT', 'email': 'nils.degrauwe@gmail.com', 'phone': '0041795560995'}], 'overallOfficials': [{'name': 'Alban Denys, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Full Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Alban Denys', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}