Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT03514251
Status:
UNKNOWN
Last Update Posted:
2018-05-02
First Post:
2018-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D007011', 'term': 'Hypoparathyroidism'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-20', 'studyFirstSubmitDate': '2018-04-20', 'studyFirstSubmitQcDate': '2018-04-20', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The stitch marking operation time', 'timeFrame': 'During surgery', 'description': 'The time required for making a parathyroid marker by a suture method'}, {'measure': 'Specimen inspection time', 'timeFrame': 'During surgery', 'description': 'The time required for finding parathyroid glands in surgical specimens'}, {'measure': 'The number of transplanted parathyroid glands', 'timeFrame': 'When the surgery is completed', 'description': 'The number of parathyroid glands required for autotransplantation of parathyroid glands'}, {'measure': 'Parathyroid hormone level testing', 'timeFrame': '0 days, 1 day, 2 weeks after surgery', 'description': 'Parathyroid hormone levels before and after surgery'}, {'measure': 'Calcium levels', 'timeFrame': '0 days, 1 day, 2 weeks after surgery', 'description': 'Calcium level before and after surgery to detect'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid Cancer', 'Hypoparathyroidism', 'parathyroid marker'], 'conditions': ['Thyroid Cancer', 'Hypoparathyroidism', 'Marker; Structural', 'Complication of Surgical Procedure', 'Parathyroid Function Low Adverse Event']}, 'descriptionModule': {'briefSummary': 'To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery', 'detailedDescription': 'This is a prospective randomized controlled study.In the experimental group, the suture parathyroid marker method was used to mark the parathyroid gland at the first time when it shows, and this marker was further used to identify and locating the inferior parathyroid marker in subsequent central region dissection. In the control group, the central area was routinely cleaned without suture parathyroid marker .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with thyroid cancer who need central compartment dissection\n* Routine neck incision surgery\n* Patients undergoing primary neck surgery\n\nExclusion Criteria:\n\n* Benign thyroid tumor patients\n* Selecting patients with endoscopes, small incisions, or robotic surgery\n* Patients with hyperparathyroidism'}, 'identificationModule': {'nctId': 'NCT03514251', 'briefTitle': 'Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery', 'orgStudyIdInfo': {'id': 'PT Marker'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Routine thyroidectomy and central lymph node dissection'}, {'type': 'EXPERIMENTAL', 'label': 'Parathyroid marker group', 'description': 'When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker.', 'interventionNames': ['Procedure: The suture marks the location of the parathyroid gland']}], 'interventions': [{'name': 'The suture marks the location of the parathyroid gland', 'type': 'PROCEDURE', 'description': 'When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker. Vascular protection.', 'armGroupLabels': ['Parathyroid marker group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'bo wang, md', 'role': 'CONTACT', 'email': 'wangbo@fjmu.edu.cn', 'phone': '13705947900'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bo Wang,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Bo Wang,MD', 'investigatorAffiliation': 'Fujian Medical University'}}}}