Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-24 @ 10:55 AM
Study NCT ID:
NCT04182256
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Spiderman for Preparation of Liver Donation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007431', 'term': 'Intraoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-11-27', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of damaged points on HVC', 'timeFrame': 'measured at the time of the end of preparation HVC; up to 1 hour', 'description': 'the number of damaged points on the HVC during the preparation'}, {'measure': 'Operation time', 'timeFrame': 'measured at the time of the end of preparation HVC; up to 1 hour', 'description': 'operation time of preparation of HVC'}, {'measure': 'The number of assistants', 'timeFrame': 'measured at the time of the end of preparation HVC; up to 1 hour', 'description': "the number of assistants ensuring smooth operation according to attending's requirement"}, {'measure': 'Leak test', 'timeFrame': 'measured at the time of the end of preparation HVC; up to 1 hour', 'description': 'we use nondestructive vascular forceps to occlude the SHVC and IHVC, and perfused about 100 ml organ preservation solution through portal vein. If HVC and portal vein bulge and does not leak, the leak test is negative. Otherwise, it is positive.'}, {'measure': 'HVC hemorrhage', 'timeFrame': 'measured at the time of liver implanted to the recipient; up to 1 hour', 'description': 'Whether HVC hemorrhage after implantation'}], 'secondaryOutcomes': [{'measure': "Frequency of MS's detachment", 'timeFrame': 'measured at the time of the end of preparation HVC; up to 1 hour', 'description': "the frequency of MS's detachment from the vasculature and basin wall."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications', 'Surgical Injury']}, 'descriptionModule': {'briefSummary': "Due to many vascular branches on the supra-hepatic vena cava (SHVC) and infra-hepatic vena cava (IHVC), in the whole procedures of preparation of liver donation, preparation of hepatic vena cava (HVC) is the most key and troublesome step. Magnetic Spiderman (MS) is a novel surgical instrument, designed and created to solve the vital problems of preparation of liver donation's HVC. Therefore, the aim of this study is to evaluate the feasibility and security of MS when using it prepare the liver donation's HVC.", 'detailedDescription': "From January 1 2020 to June 30 2020, after inclusion and exclusion, donors' livers will be divided to MS group and manual (MA) group. In MS group, MS grips the SHVC and IHVC, respectively. MS's magnets are adsorbed on the wall of the basin and MS can pull the HVC accordingly. By changing the position of MS on the wall of the basin, the attending can expose the surgical field that make the operation convenient. In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements. In both groups, right adrenal vein, phrenic veins and other branches of the HVC are isolated and ligated, then SHVC and IHVC where MS's clamps gripped are cut off. After preparation, the SHVC and IHVC remain at least 1.5 cm. Excess diaphragms are removed. Outcomes of two groups are compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* all patients receiving donation after cardiac death in the First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University.\n\nExclusion Criteria:\n\n* patients whose age\\<18, or \\>60\n* patients who do not have intact clinical data\n* patients who are inability to participate in follow-up\n* patients who undergo split liver transplantation"}, 'identificationModule': {'nctId': 'NCT04182256', 'acronym': 'MSPLD', 'briefTitle': 'Magnetic Spiderman for Preparation of Liver Donation', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': "A Prospective Study: Magnetic Spiderman for Preparation of Donor Livers' Inferior Vena Cava", 'orgStudyIdInfo': {'id': 'XJYFY-2017ZD1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MS group', 'description': 'In the MS group, the MS grips the HVC through the magnet adsorbed onto the wall of the basin containing the liver. By changing the position of the MS on the wall of the basin, the surgeon is able to expose the surgical field.', 'interventionNames': ['Device: MS']}, {'type': 'NO_INTERVENTION', 'label': 'MA group', 'description': "In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements."}], 'interventions': [{'name': 'MS', 'type': 'DEVICE', 'description': 'Magnetic Spiderman (MS) is a novel surgical instrumentIt. It consists of a circular neodymium iron boron magnet packed in a stainless-steel case with a spring and a jagged clamp, which gives it a spider-like appearance.', 'armGroupLabels': ['MS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'First Affiliated Hospital of Xian JiaotongUniversity', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}