Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04740502
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2021-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049950', 'term': 'Hyperparathyroidism, Primary'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-02-01', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical failure', 'timeFrame': '6 months', 'description': 'Incidence of persistent hyperparathyroidism'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Hyperparathyroidism']}, 'descriptionModule': {'briefSummary': 'Although some surgeons still consider bilateral neck exploration as the best approach for primary hyperparathyroidism, nowadays most of them perceive the mini-invasive parathyroidectomy (MIP) as the best option for patients with concordant preoperative studies. Nevertheless, the consensus is heterogeneous for patients with unclear localisation studies, with some surgeons deeming BNE as mandatory and others suggesting that a mini-invasive approach is still possible if combined with IOPTH monitoring. In our research, we focused on patients with unclear preoperative localisation studies, to better understand the factors that can determine discordant or negative results between US and MIBI scan, in order to choose the best surgical approach and to evaluate the outcomes in this kind of patients.', 'detailedDescription': 'This is an unicentric, retrospective study on patients who underwent surgery for PHP from January 2004 to June 2020 at our Department of General and Endocrine surgery, which is a tertiary referral centre for parathyroid disease. Ethical approval was released from our Local Independent Ethical Committee. Patients involved in the study subjects gave informed consent to the work.\n\nIn our study, we included only patients who underwent both US and MIBI preoperatively. The exclusion criteria were the association of total or partial thyroidectomy planned preoperatively for thyroid disease, reoperative surgery for persistent or recurrent PHP, and incomplete data or follow-up.\n\nThe primary aims of this study were:\n\n* To identify predictive factors of unclear preoperative localisation studies.\n* To evaluate if a mini-invasive approach is feasible in this kind of patients, considering the incidence of persistent PHP as the main outcome.\n\nThe secondary outcomes were:\n\n* To assess the role of IOPTH assay in patients with unclear localisation studies.\n* To evaluate the accuracy of preoperative localisation studies in our series, particularly in patients with discordant or negative US and MIBI scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary hyperparathyroidism\n\nExclusion Criteria:\n\n* Patients with concomitant thyroid disease'}, 'identificationModule': {'nctId': 'NCT04740502', 'briefTitle': 'Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Surgical Approach and Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies', 'orgStudyIdInfo': {'id': 'PHP-DISC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Concordant preoperative studies', 'description': 'Patients with concordant neck ultrasound and MIBI scan', 'interventionNames': ['Procedure: Parahtyroidectomy']}, {'type': 'OTHER', 'label': 'Unclear preoperative studies', 'description': 'Patients with discordant or negative neck ultrasound and MIBI scan', 'interventionNames': ['Procedure: Parahtyroidectomy']}], 'interventions': [{'name': 'Parahtyroidectomy', 'type': 'PROCEDURE', 'description': 'Parathyroidectomy', 'armGroupLabels': ['Concordant preoperative studies', 'Unclear preoperative studies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09040', 'city': 'Monserrato', 'state': 'Cagliari', 'country': 'Italy', 'facility': 'Policlinico di Monserrato', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}, {'zip': '09042', 'city': 'Monserrato', 'state': 'CA', 'country': 'Italy', 'facility': 'Policlinico di Monserrato', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Fabio Medas', 'investigatorAffiliation': 'University of Cagliari'}}}}