Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT07263503
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clip and Coil in Fundal Gastric Varices With a Large Shunt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gastric variceal pressure gradient', 'timeFrame': 'During the endoscopic intervention'}], 'primaryOutcomes': [{'measure': 'The occurrence of ectopic embolization', 'timeFrame': 'Within the day of the endoscopic intervention (after the operation)'}], 'secondaryOutcomes': [{'measure': 'The occurrence of coil migration', 'timeFrame': 'Within the day of the endoscopic intervention (after the operation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fundal Gastric Varices', 'Endoscopic Ultrasound (EUS)-Guided Coil Deployment', 'Titanium Clips', 'Ectopic Embolization', 'Gastric Variceal Pressure']}, 'descriptionModule': {'briefSummary': 'Endoscopic ultrasound (EUS)-guided coil deployment is a promising technique for the endoscopic management of gastric varices. However, coil migration may occur in patients with large drainage collaterals. This study aimed to evaluate the safety and efficacy of using clips in combination with coils for treating gastric varices. In this retrospective study, clips were placed before EUS-guided coil deployment in each patient with gastric varices and a large spontaneous portosystemic shunt. The pressure of gastric varices was directly measured by puncturing the varix with a needle connected to a pressure transducer, before and after clip placement. The occurrence of ectopic embolization or coil migration was recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with fundal gastric varices, admitted for endoscopic intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. presence of a spontaneous portosystemic shunt, including gastrorenal or splenorenal collateral shunts;\n2. use of both clips and coils during endoscopic intervention.\n\nExclusion Criteria:\n\nThe spontaneous portosystemic shunt was narrow (diameter \\< 1.0 cm).'}, 'identificationModule': {'nctId': 'NCT07263503', 'briefTitle': 'Clip and Coil in Fundal Gastric Varices With a Large Shunt', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clip and Coil: A Novel Safe Strategy in Managing Fundal Gastric Varices With a Large Spontaneous Portosystemic Shunt', 'orgStudyIdInfo': {'id': '2025-1588'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fundal gastric varices associated with a large spontaneous portosystemic shunt (>1cm)', 'description': 'Clips were placed before EUS-guided coil deployment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}