Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 1:25 PM
Study NCT ID:
NCT07229859
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robotic Surgery Via Bilateral Axillo-breast Approach for Relatively Low-risk Papillary Thyroid Carcinoma With Lateral Cervical Lymph Node Metastasis: a Safe and Effective Cosmetic Procedure in the Context of Prevalent Thyroid Ultrasound Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of retrieved Lymph nodes', 'timeFrame': 'From enrollment to the end of surgical procedure'}, {'measure': 'postoperative complications', 'timeFrame': 'From enrollment to the end of treatment at 1 year', 'description': 'Vocal cord paralysis; hypocalcemia; spinal accessory nerve injury; chyle leakage'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Differentiated Thyroid Cancer (DTC)', 'Robotic Assistance']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn the efficacy, cosmetic effectiveness and safety of robotic modified radical neck dissection in well-selected cases, through direct comparison with conventional open surgery in low-risk papillary thyroid carcinoma with lateral cervical lymph node metastasis. The main questions it aims to answer are:\n\nDoes robotic neck dissection provide tumor clearance equivalent to that of the conventional open approach? How does the postoperative complication rate of the robotic technique compare with open surgery? Are patients satisfied with the cosmetic appearance of the wound following robotic neck dissection? Researchers will compare robotic surgery with conventional open surgery to see if it has the same efficacy, cosmetic effectiveness and safety.\n\nParticipants' postoperative recovery will be followed up, and they will provide pain scores and rate their cosmetic satisfaction with the wound."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population came from a single high-volume thyroid center, with all surgeries performed by the same surgeon.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) PTC with lateral LN metastasis confirmed by fine needle aspiration (FNA) biopsy;\n* (2) maximum tumor size \\< 3 cm;\n* (3) without extrathyroidal extension;\n* (4) metastatic LNs in unilateral levels II, III, IV and/or V;\n* (5) number of suspicious metastatic LNs based on preoperative ultrasonography \\< 5;\n* (6) maximum metastatic LN diameter \\< 3 cm.\n\nExclusion Criteria:\n\n* (1) metastatic LNs in level I or VII;\n* (2) metastatic LNs fused with each other or fixed in the neck or extra-nodal extension;\n* (3) history of neck surgery or radiation therapy;\n* (4) extranodal extension;\n* (5) the presence of TERT mutation.'}, 'identificationModule': {'nctId': 'NCT07229859', 'briefTitle': 'Robotic Surgery Via Bilateral Axillo-breast Approach for Relatively Low-risk Papillary Thyroid Carcinoma With Lateral Cervical Lymph Node Metastasis: a Safe and Effective Cosmetic Procedure in the Context of Prevalent Thyroid Ultrasound Screening', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Robotic Surgery Via Bilateral Axillo-breast Approach for Relatively Low-risk Papillary Thyroid Carcinoma With Lateral Cervical Lymph Node Metastasis: a Safe and Effective Cosmetic Procedure in the Context of Prevalent Thyroid Ultrasound Screening', 'orgStudyIdInfo': {'id': 'RHEC-D-2021-024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'robotic modified radical neck dissection group'}, {'label': 'open modified radical neck dissection group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}