Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 12:55 AM
Study NCT ID:
NCT04666103
Status:
RECRUITING
Last Update Posted:
2020-12-14
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Function Integrity of Neck Anatomy in Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1264}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2026-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of complications', 'timeFrame': 'Up to 2 years', 'description': 'Transient or persistent hypoparathyroidism confirmed by serum calcium levels was less than the lower limit at examination center and had symptoms of hypocalcemia. Postoperative vocal cord paralysis was defined as fixed vocal cord mobility with laryngofiberoscopic examination.'}, {'measure': 'Scores of hospital anxiety and depression scale (HADS)', 'timeFrame': 'Up to 6 months', 'description': 'All patients were requested to answer the HADS questionnaire, the scores of which were recorded.'}, {'measure': 'Scores of fear of progression questionnaire-short form(FPQS)', 'timeFrame': 'Up to 6 months', 'description': 'All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.'}, {'measure': 'Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire', 'timeFrame': 'Up to 6 months', 'description': 'All patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.'}, {'measure': 'Rate of recurrence', 'timeFrame': '5-year estimate reported after a median follow-up of 60 months', 'description': 'Lymph node recurrence or distant recurrence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Carcinoma', 'Thyroid Nodule (Benign)', 'Ablation; Retina']}, 'descriptionModule': {'briefSummary': 'Recent trends in the management of patients with low-risk papillary thyroid carcinoma who have a nonsuspicious or cytologically benign contralateral nodule call into question the need for routine total thyroidectomy. Although the lobectomy for the unilateral thyroid cancer with contralateral benign nodules is sufficient treatment, some of the patients might suffer from the anxiety of the residual benign thyroid nodule and tend to choose total thyroidectomy, which might be overtreatment.\n\nThermal ablation has been proven to be effective in achieving nodule shrinkage and being also free from major complications. In our institution, intraoperative RFA was a proposed alternative strategy to treat the contralateral benign nodules after the thyroid lobectomy for the malignant lobe, which was found to have a better quality of life on anxiety, physiological health, social family, psychological and sensory mentions with a considerable complication rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with unilateral thyroid carcinoma and contralateral benign nodule confirmed by preoperative ultrasound-guided fine-needle aspiration cytology;\n* Patients with contralateral nodules ≤ 20mm and located in the thyroid gland;\n* Patients with clinical node-negative cervical compartment at palpation and neck ultrasound.\n\nExclusion Criteria:\n\n* Previous history of neck surgery\n* Previous history of neck radiation therapy'}, 'identificationModule': {'nctId': 'NCT04666103', 'briefTitle': 'Function Integrity of Neck Anatomy in Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan University'}, 'officialTitle': 'Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'lycf202007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thyroid lobectomy with intraoperative thermal ablation', 'description': 'Thyroid lobectomy was performed with a standard technique of fine capsular en bloc dissection and resection, from inferior pole to superior pole. Superior parathyroid glands were identified and preserved in situ, inferior parathyroid glands were protected in situ or autotransplanted in the sternocleidomastoid muscle according to three certain types based on their blood supply and location. All the patients underwent lobectomy received ipsilateral therapic central compartment neck dissection. After the thyroid lobectomy, the contralateral benign thyroid nodule was treated with intraoperative thermal ablation. The "hydrodissection technique" was used during the ablation process to prevent recurrent laryngeal nerve, esophageal and other important structures from being destroyed by heat energy.', 'interventionNames': ['Procedure: Intraoperative thermal ablation']}, {'type': 'NO_INTERVENTION', 'label': 'Thyroid lobectomy', 'description': 'Thyroid lobectomy was performed with a standard technique of fine capsular en bloc dissection and resection, from inferior pole to superior pole. Superior parathyroid glands were identified and preserved in situ, inferior parathyroid glands were protected in situ or autotransplanted in the sternocleidomastoid muscle according to three certain types based on their blood supply and location. All the patients underwent lobectomy received ipsilateral therapic central compartment neck dissection.'}], 'interventions': [{'name': 'Intraoperative thermal ablation', 'type': 'PROCEDURE', 'description': 'After the thyroid lobectomy, the contralateral benign thyroid nodule was treated with intraoperative thermal ablation. The "hydrodissection technique\'\' was used during the ablation process to prevent recurrent laryngeal nerve, esophageal and other important structures from being destroyed by heat energy.', 'armGroupLabels': ['Thyroid lobectomy with intraoperative thermal ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qianqian Yuan, MD.', 'role': 'CONTACT', 'email': 'Yuanqq11@whu.edu.cn', 'phone': '+8613026322297'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qianqian Yuan, M.D.', 'role': 'CONTACT', 'email': 'Yuanqq11@whu.edu.cn', 'phone': '13026322297'}], 'overallOfficials': [{'name': 'Gaosong Wu, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Breast and Thyroid Surgery, Zhongnan Hospital of Wuhan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Gaosong Wu, Ph D, MD', 'investigatorAffiliation': 'Wuhan University'}}}}