Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:46 PM
Study NCT ID:
NCT05573828
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2022-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006996', 'term': 'Hypocalcemia'}], 'ancestors': [{'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 394}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of participants with postoperative permanent hypoparathyroidism', 'timeFrame': '1 year', 'description': 'Comparison of postoperative permanent hypoparathyroidism between the two groups. It is considered permanent hypoparathyroidism in the presence of symptoms of hypocalcemia or less than 1.8mmol/L of calcium in asymptomatic patients during more than 12 months.'}], 'secondaryOutcomes': [{'measure': 'Rate of participants with severe permanent hypocalcemia', 'timeFrame': '1 year', 'description': 'Comparison of the occurrence of severe permanent hypocalcemia after total thyroidectomy between the two groups. Severe hypocalcemia is considered when vitamin D is added to the treatment with calcium. Permanent hypocalcemia is defined when it lasts more than 12 months.'}, {'measure': 'Number of parathyroid glands identified and preserved', 'timeFrame': '1 year', 'description': 'Comparison of the number of parathyroid glands identified, left in situ and with an ICG score of 2 after total thyroidectomy between the two groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypocalcemia', 'ICG angiography', 'Guided thyroidectomy'], 'conditions': ['Iatrogenic Hypocalcemia']}, 'referencesModule': {'references': [{'pmid': '24402815', 'type': 'BACKGROUND', 'citation': 'Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.'}, {'pmid': '27568330', 'type': 'BACKGROUND', 'citation': 'Vidal Fortuny J, Sadowski SM, Belfontali V, Karenovics W, Guigard S, Triponez F. Indocyanine Green Angiography in Subtotal Parathyroidectomy: Technique for the Function of the Parathyroid Remnant. J Am Coll Surg. 2016 Nov;223(5):e43-e49. doi: 10.1016/j.jamcollsurg.2016.08.540. Epub 2016 Aug 24. No abstract available.'}, {'pmid': '28364157', 'type': 'BACKGROUND', 'citation': 'Falco J, Dip F, Quadri P, de la Fuente M, Prunello M, Rosenthal RJ. Increased identification of parathyroid glands using near infrared light during thyroid and parathyroid surgery. Surg Endosc. 2017 Sep;31(9):3737-3742. doi: 10.1007/s00464-017-5424-1. Epub 2017 Mar 31.'}, {'pmid': '34743241', 'type': 'BACKGROUND', 'citation': 'Benmiloud F, Penaranda G, Chiche L, Rebaudet S. Intraoperative Mapping Angiograms of the Parathyroid Glands Using Indocyanine Green During Thyroid Surgery: Results of the Fluogreen Study. World J Surg. 2022 Feb;46(2):416-424. doi: 10.1007/s00268-021-06353-4. Epub 2021 Nov 6.'}, {'pmid': '31617879', 'type': 'BACKGROUND', 'citation': 'Llorente PM, Francos Martinez JM, Barrasa AG. Intraoperative Parathyroid Hormone Measurement vs Indocyanine Green Angiography of Parathyroid Glands in Prediction of Early Postthyroidectomy Hypocalcemia. JAMA Surg. 2020 Jan 1;155(1):84-85. doi: 10.1001/jamasurg.2019.3652.'}, {'pmid': '35945357', 'type': 'RESULT', 'citation': 'Moreno-Llorente P, Garcia-Barrasa A, Pascua-Sole M, Videla S, Otero A, Munoz-de Nova JL. Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. World J Surg. 2023 Feb;47(2):421-428. doi: 10.1007/s00268-022-06683-x. Epub 2022 Aug 9.'}, {'pmid': '37223015', 'type': 'DERIVED', 'citation': 'Moreno-Llorente P, Garcia-Gonzalez G, Pascua-Sole M, Garcia-Barrasa A, Videla S, Munoz-de-Nova JL; GuiArte Study Group. Indocyanine green angiography-guided thyroidectomy versus conventional thyroidectomy for preserving parathyroid function: study protocol for a randomized single-blind controlled trial. Front Endocrinol (Lausanne). 2023 May 8;14:1193900. doi: 10.3389/fendo.2023.1193900. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Transient and/or permanent hypoparathyroidism is the most frequent complication after total thyroidectomy. The identification of the parathyroid glands and a correct dissection during thyroidectomy have been postulated as key factors for their preservation and, consequently, to prevent hypoparathyroidism. The use of indocyanine green (ICG) fluorescence has reliably predicted parathyroid glands functionality in the immediate postoperative period. Recently, it is proposed that showing the vascular map of the parathyroid glands before performing the thyroidectomy by means of ICG angiography prevent the development of postoperative hypoparathyroidism.\n\nThe goal of this multicentric study is to demonstrate that the preservation of the function of parathyroid glands is greater with use of arteriography than without.\n\nPatients will be divided in two groups. In the study group, the vascular map with ICG of parathyroid glands will be showed before performing the lobectomy. Once the lobectomy is done, the function of the glands will be assessed. Whereas in the control group, arteriography with ICG will only be carried out in order to check their function at the end of the lobectomy.\n\nResearchers will compare the study group and the control group to see which one present the lowest taxes of postoperative hypoparathyroidism.', 'detailedDescription': 'To assess the appearance of postoperative hypoparathyroidism, a systematic determination of PTH and corrected calcium values will be carried out the morning after the intervention.\n\nIt will be considered that there is hypoparathyroidism when the patient presents symptoms of hypocalcaemia, when he has required the administration of calcium and/or vitamin D prior to this determination or when he presents corrected calcium values \\< 1.8 mmol/L.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid pathology.\n* The patient or their guardian, where applicable, has the capacity to understand the study and agrees to participate in it, signing the corresponding informed consent document.\n\nExclusion Criteria:\n\n* Previous surgical intervention on the thyroid or parathyroid gland.\n* Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act.\n* Patients with contraindications for the administration of ICG.\n* Current drug use or alcohol abuse that could interfere with compliance with the study requirements.\n* Participation in any other drug trials in the month prior to randomization.'}, 'identificationModule': {'nctId': 'NCT05573828', 'acronym': 'GuiArte', 'briefTitle': 'Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.', 'orgStudyIdInfo': {'id': 'PR161/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Angiography group', 'description': 'Patients undergoing initially ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid function.', 'interventionNames': ['Procedure: ICG angiography to show vascular map of parathyroid glands']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients who underwent post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the parathyroid glands'}], 'interventions': [{'name': 'ICG angiography to show vascular map of parathyroid glands', 'type': 'PROCEDURE', 'description': 'Using ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then perform the thyroidectomy. After it, ICG angiography is done to predict immediate parathyroid functio', 'armGroupLabels': ['Angiography group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pablo Moreno', 'role': 'CONTACT', 'email': '25108pml@gmail.com', 'phone': '34 661214772'}], 'facility': 'Hospital UIniversitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pablo Moreno', 'role': 'CONTACT', 'email': '25108pml@gmail.com', 'phone': '661214772'}], 'facility': 'Pablo Moreno Llorente', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'centralContacts': [{'name': 'Pablo Moreno', 'role': 'CONTACT', 'email': '25108pml@gmail.com', 'phone': '661214772'}], 'overallOfficials': [{'name': 'Pablo Moreno', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari de Bellvitge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Endocrine Surgery', 'investigatorFullName': 'Pablo Moreno Llorente', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}