Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT01510002
Status:
COMPLETED
Last Update Posted:
2012-01-13
First Post:
2012-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Central Neck Dissection for Papillary Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}], 'ancestors': [{'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-10', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-10', 'lastUpdatePostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'up to 10 years'}, {'measure': 'disease-specific survival', 'timeFrame': 'up to 10 years'}, {'measure': 'locoregional control', 'timeFrame': 'up to 10 years'}], 'secondaryOutcomes': [{'measure': 'number of patients with negative serum thyroglobulin levels', 'timeFrame': 'up to 10 years'}, {'measure': 'postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).', 'timeFrame': 'up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['papillary thyroid cancer', 'central neck dissection', 'survival', 'locoregional control', 'morbidity'], 'conditions': ['Papillary Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '21135696', 'type': 'BACKGROUND', 'citation': "Forest VI, Clark JR, Ebrahimi A, Cho EA, Sneddon L, Gao K, O'brien CJ. Central compartment dissection in thyroid papillary carcinoma. Ann Surg. 2011 Jan;253(1):123-30. doi: 10.1097/SLA.0b013e3181fc9644."}, {'pmid': '21722150', 'type': 'BACKGROUND', 'citation': 'Mulla M, Schulte KM. Central cervical lymph node metastases in papillary thyroid cancer: a systematic review of imaging-guided and prophylactic removal of the central compartment. Clin Endocrinol (Oxf). 2012 Jan;76(1):131-6. doi: 10.1111/j.1365-2265.2011.04162.x.'}, {'pmid': '22136820', 'type': 'BACKGROUND', 'citation': 'Popadich A, Levin O, Lee JC, Smooke-Praw S, Ro K, Fazel M, Arora A, Tolley NS, Palazzo F, Learoyd DL, Sidhu S, Delbridge L, Sywak M, Yeh MW. A multicenter cohort study of total thyroidectomy and routine central lymph node dissection for cN0 papillary thyroid cancer. Surgery. 2011 Dec;150(6):1048-57. doi: 10.1016/j.surg.2011.09.003.'}, {'pmid': '19375610', 'type': 'BACKGROUND', 'citation': 'Alvarado R, Sywak MS, Delbridge L, Sidhu SB. Central lymph node dissection as a secondary procedure for papillary thyroid cancer: Is there added morbidity? Surgery. 2009 May;145(5):514-8. doi: 10.1016/j.surg.2009.01.013. Epub 2009 Mar 27.'}, {'pmid': '17388820', 'type': 'BACKGROUND', 'citation': 'Grodski S, Cornford L, Sywak M, Sidhu S, Delbridge L. Routine level VI lymph node dissection for papillary thyroid cancer: surgical technique. ANZ J Surg. 2007 Apr;77(4):203-8. doi: 10.1111/j.1445-2197.2007.04019.x.'}, {'pmid': '19661784', 'type': 'BACKGROUND', 'citation': 'Moo TA, Umunna B, Kato M, Butriago D, Kundel A, Lee JA, Zarnegar R, Fahey TJ 3rd. Ipsilateral versus bilateral central neck lymph node dissection in papillary thyroid carcinoma. Ann Surg. 2009 Sep;250(3):403-8. doi: 10.1097/SLA.0b013e3181b3adab.'}, {'pmid': '22005150', 'type': 'BACKGROUND', 'citation': 'Barczynski M, Konturek A, Stopa M, Cichon S, Richter P, Nowak W. Total thyroidectomy for benign thyroid disease: is it really worthwhile? Ann Surg. 2011 Nov;254(5):724-29; discussion 729-30. doi: 10.1097/SLA.0b013e3182360118.'}, {'pmid': '23188784', 'type': 'DERIVED', 'citation': 'Barczynski M, Konturek A, Stopa M, Nowak W. Prophylactic central neck dissection for papillary thyroid cancer. Br J Surg. 2013 Feb;100(3):410-8. doi: 10.1002/bjs.8985. Epub 2012 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative.', 'detailedDescription': 'Several respected organizations have recently recommended that total thyroidectomy plus prophylactic central neck dissection should be the standard operation for papillary thyroid cancer. However, it is still unclear if this approach has any benefit on survival or locoregional control of the disease. In addition, potential advantages of this more aggressive surgical approach should outweigh the risk of morbidity. The purpose of this retrospective cohort study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative. In this study outcomes of total thyroidectomy versus this plus prophylactic central neck dissection for papillary thyroid cancer are compared in a 10-year follow-up. Patients operated between 1993 and 1997 (n=282) underwent total thyroidectomy alone, whereas patients operated between 1998 and 2002 (n=358) underwent total thyroidectomy plus prophylactic central neck dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a pathological diagnosis of papillary thyroid cancer,\n* in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation\n\nExclusion Criteria:\n\n* incidental diagnosis of papillary thyroid cancer following hemithyroidectomy and requiring completion thyroidectomy,\n* one-stage lymph nodes dissection based on therapeutic intent,\n* previous thyroid surgery,\n* incomplete follow-up information,\n* incomplete histopathology report,\n* ASA grade higher than 3 (American Society of Anesthesiology)'}, 'identificationModule': {'nctId': 'NCT01510002', 'briefTitle': 'Prophylactic Central Neck Dissection for Papillary Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Prophylactic Central Neck Dissection for Papillary Thyroid Cancer', 'orgStudyIdInfo': {'id': 'BBN/501/ZKL/1447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TT', 'description': 'Extracapsular total thyroidectomy', 'interventionNames': ['Procedure: Total thyroidectomy']}, {'type': 'EXPERIMENTAL', 'label': 'TT+CND', 'description': 'Extracapsular total thyroidectomy puls prophylactic central neck dissection', 'interventionNames': ['Procedure: Total thyroidectomy + prophylactic central neck dissection']}], 'interventions': [{'name': 'Total thyroidectomy', 'type': 'PROCEDURE', 'description': 'Extracapsular total thyroidectomy', 'armGroupLabels': ['TT']}, {'name': 'Total thyroidectomy + prophylactic central neck dissection', 'type': 'PROCEDURE', 'description': 'Extracapsular total thyroidectomy plus prophylactic central neck dissection', 'armGroupLabels': ['TT+CND']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-202', 'city': 'Krakow', 'state': 'Malopolska', 'country': 'Poland', 'facility': 'Jagiellonian Univerity, Medical College, 3rd Department of General Surgery', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Marcin Barczynski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marcin Barczynski', 'investigatorAffiliation': 'Jagiellonian University'}}}}