Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 11:23 AM
Study NCT ID:
NCT04922892
Status:
RECRUITING
Last Update Posted:
2021-09-27
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016105', 'term': 'Parathyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of recurrent', 'timeFrame': '60 months', 'description': 'the rate of recurrent'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis'], 'conditions': ['Secondary Hyperparathyroidism;Parathyroidectomy']}, 'referencesModule': {'references': [{'pmid': '27741007', 'type': 'RESULT', 'citation': 'Schlosser K, Bartsch DK, Diener MK, Seiler CM, Bruckner T, Nies C, Meyer M, Neudecker J, Goretzki PE, Glockzin G, Konopke R, Rothmund M. Total Parathyroidectomy With Routine Thymectomy and Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism: Results of a Nonconfirmatory Multicenter Prospective Randomized Controlled Pilot Trial. Ann Surg. 2016 Nov;264(5):745-753. doi: 10.1097/SLA.0000000000001875.'}, {'pmid': '17877805', 'type': 'RESULT', 'citation': 'Schlosser K, Veit JA, Witte S, Fernandez ED, Victor N, Knaebel HP, Seiler CM, Rothmund M. Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial. Trials. 2007 Sep 18;8:22. doi: 10.1186/1745-6215-8-22.'}, {'pmid': '29083339', 'type': 'RESULT', 'citation': 'Abruzzo A, Gioviale MC, Damiano G, Palumbo VD, Buscemi S, Lo Monte G, Gulotta L, Buscemi G, Lo Monte AI. Reoperation for persistent or recurrent secondary hyperparathyroidism. Acta Biomed. 2017 Oct 23;88(3):325-328. doi: 10.23750/abm.v88i3.4722.'}, {'pmid': '20641052', 'type': 'RESULT', 'citation': 'Coulston JE, Egan R, Willis E, Morgan JD. Total parathyroidectomy without autotransplantation for renal hyperparathyroidism. Br J Surg. 2010 Nov;97(11):1674-9. doi: 10.1002/bjs.7192.'}]}, 'descriptionModule': {'briefSummary': 'Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.', 'detailedDescription': 'The trial was performed as a nonconfirmatory randomized controlled pilot trial with 200 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 5-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 5-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSevere renal secondary hyperparathyroidism\n\nExclusion Criteria:\n\nPatients with diabetes a history of chronic inflammatory disease a history of malignant tumor a history of kidney transplantation a history of neck surgery a history of alcohol abuse a history of drug abuse inability to cooperate with the participants refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT04922892', 'briefTitle': 'Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism', 'orgStudyIdInfo': {'id': 'TOTAR-2021-05-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Total Parathyroidectomy Alone', 'description': 'Total Parathyroidectomy Alone , without autotransplantation', 'interventionNames': ['Procedure: Parathyroidectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total Parathyroidectomy With Autotransplantation', 'description': 'Total Parathyroidectomy With Autotransplantation', 'interventionNames': ['Procedure: Parathyroidectomy']}], 'interventions': [{'name': 'Parathyroidectomy', 'type': 'PROCEDURE', 'description': 'Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone', 'armGroupLabels': ['Total Parathyroidectomy Alone', 'Total Parathyroidectomy With Autotransplantation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingxia XIONG, Ph.D', 'role': 'CONTACT', 'phone': '13951880995'}], 'facility': 'NanjingMU', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Mingxia XIONG, Ph.D', 'role': 'CONTACT', 'email': 'xiongmingxia@njmu.edu.cn', 'phone': '13951880995'}], 'overallOfficials': [{'name': 'Mingxia XIONG, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Medcial university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}