Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT04223466
Status:
RECRUITING
Last Update Posted:
2022-11-16
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale of postoperative pain', 'timeFrame': 'within 3 days', 'description': 'in score'}, {'measure': 'Operation time', 'timeFrame': 'one day', 'description': 'in minutes'}, {'measure': 'The amount of blood loss', 'timeFrame': 'one day', 'description': 'in milliliter'}, {'measure': 'Duration of drainage', 'timeFrame': 'with 7 days', 'description': 'in days'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'with 7 days', 'description': 'in days'}], 'secondaryOutcomes': [{'measure': 'Complete remission rates', 'timeFrame': '5 years', 'description': 'Complete remission rates after 5 year follow-up of thymectomy for myasthenia gravis'}, {'measure': 'Recurrence rate', 'timeFrame': '5 years', 'description': 'Recurrence rate after 5 year follow-up of thymectomy for thymoma'}, {'measure': 'Overall survival', 'timeFrame': 'within 10 years', 'description': 'Overall survival in rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Video-assisted thoracoscopic surgery', 'Subxiphoid approach'], 'conditions': ['Thymectomy']}, 'descriptionModule': {'briefSummary': 'Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Thymoma with or without myasthenia gravis；\n2. Generalized myasthenia gravis not sensitive to conservative medicine treatment;\n3. Good cardiopulmonary function.\n\nExclusion Criteria:\n\n1. Cardiopulmonary function can't bear surgery;\n2. Generalized myasthenia gravis with MuSK(+)."}, 'identificationModule': {'nctId': 'NCT04223466', 'briefTitle': 'Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Shandong University'}, 'officialTitle': 'Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results', 'orgStudyIdInfo': {'id': 'Subxiphoid ZYP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subxiphoid group', 'description': 'Subxiphoid procedure for thymectomy.', 'interventionNames': ['Procedure: Subxiphoid surgery procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VATS group', 'description': 'Video-assisted thoracoscopic thymectomy through chest wall.', 'interventionNames': ['Procedure: VATS surgery procedure']}], 'interventions': [{'name': 'Subxiphoid surgery procedure', 'type': 'PROCEDURE', 'description': 'Subxiphoid procedure for thymectomy', 'armGroupLabels': ['Subxiphoid group']}, {'name': 'VATS surgery procedure', 'type': 'PROCEDURE', 'description': 'VATS procedure for thymectomy', 'armGroupLabels': ['VATS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250033', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunpeng', 'role': 'CONTACT', 'email': 'zyp_baggio@163.com', 'phone': '+8618766188692'}], 'facility': 'Yunpeng', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yunpeng Zhao', 'role': 'CONTACT', 'email': 'zyp_baggio@163.com', 'phone': '+8618766188692'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}