Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-01 @ 6:46 AM
Study NCT ID:
NCT07107503
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2025-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
10 Years' Follow-up Results of Ultrasound-guided Radiofrequency Ablation Versus Surgery for Low-risk Papillary Thyroid Micro-carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563277', 'term': 'Papillary Thyroid Microcarcinoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 757}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor progression', 'timeFrame': 'The RFA group follow-ups were conducted at 1, 3, 6, 12, and every 12 months thereafter. The SR group follow-ups were conducted at 1, 6, 12 and every 12 months thereafter. All the patients finished at least 10-year follow-ups.', 'description': 'Tumor progression included (1) local recurrence confirmed by biopsy, (2) new PTMC tumors confirmed by biopsy, (3) LN metastasis confirmed by biopsy, and (4) distant metastases.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Papillary Thyroid Microcarcinoma', 'Radiofrequency Ablation', 'Surgical Resection', 'Long-term Outcomes']}, 'descriptionModule': {'briefSummary': "Papillary thyroid micro-carcinoma (PTMC) generally demonstrates favorable prognosis. However, the potential risk of disease progression requires careful therapeutic consideration. Radiofrequency ablation (RFA) has garnered attention as a minimally invasive treatment option for patients with PTMC who choose to decline both surgical resection (SR) and active surveillance. However, comprehensive comparative studies evaluating RFA versus surgery regarding long-term oncological efficacy, quality-of-life, and cost-effectiveness in multicenter cohorts remain warranted. To compare the oncological outcomes, quality of life, and cost-effectiveness between RFA and SR for low-risk PTMC over 10 years' follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective multi-center study included patients with PTMC treated at four university-affiliated hospitals in China from April 2011 to December 2014.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(a) PTC confirmed at FNA or CNB, with a maximum diameter of 1 cm; (b) no clinical or imaging evidence of extra-thyroidal extension (41-42) and no evidence of metastasis at preoperative ultrasonography (US) or neck computed tomography (CT), indicating clinical preoperative T1aN0M0; (c) no history of neck irradiation; (d) no prior thyroid surgery; (e) follow-up of ≥ 120 months.\n\nExclusion Criteria:\n\n(a) severe coagulation disorder or organ failure, (b) evidence of an aggressive sub-type of PTC on biopsy, and (c) incomplete data.'}, 'identificationModule': {'nctId': 'NCT07107503', 'briefTitle': "10 Years' Follow-up Results of Ultrasound-guided Radiofrequency Ablation Versus Surgery for Low-risk Papillary Thyroid Micro-carcinoma", 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': "10 Years' Follow-up Results of Ultrasound-guided Radiofrequency Ablation Versus Surgery for Low-risk Papillary Thyroid Micro-carcinoma", 'orgStudyIdInfo': {'id': 'ChinaPLAGH202506'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiofrequency ablation', 'interventionNames': ['Procedure: Radiofrequency ablation alone']}, {'label': 'surgical resection', 'interventionNames': ['Procedure: surgical resection']}], 'interventions': [{'name': 'Radiofrequency ablation alone', 'type': 'PROCEDURE', 'description': 'RFA was performed by four US physicians with ≥ 10 years of experience in in-terventional US. Before ablation, the patients were placed in the supine position with the neck extended, and local anesthesia was administered with lidocaine (1%). RFAs were performed using the hydro-dissection, trans-isthmic and moving-shot techniques according to previously published guidelines. Ablation was terminated when the target tumor changed to a transient hyperechoic zone. Contrast-enhanced US (CEUS) was performed immediately after ablation to evaluate the ablation area. The presence of complications during or after thermal ablation and corresponding treatments was carefully evaluated. All patients were closely observed for 1-2 h after ablation in the hospital.', 'armGroupLabels': ['Radiofrequency ablation']}, {'name': 'surgical resection', 'type': 'PROCEDURE', 'description': 'SR was performed under general anesthesia by surgeons with\\>15 years of expe-rience in thyroid surgery. The decision to perform total thyroidectomy or lobectomy was made by individual surgeons and patients, based on patient preferences in consu', 'armGroupLabels': ['surgical resection']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yi Mao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'clinician', 'investigatorFullName': 'Yi Mao', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}