[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585206":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":32,"collaborators":11,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":11,"enrollmentInfo":46,"targetDuration":11,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":11},{"fullName":5,"class":6},"University of Pisa","OTHER",[8,12,17,19],{"label":9,"type":10,"description":11,"interventionNames":11},"Total Thyroidectomy","NO_INTERVENTION",null,{"label":13,"type":14,"description":11,"interventionNames":15},"Total Thyroidectomy + pCCND","EXPERIMENTAL",[16],"Procedure: Total Thyroidectomy + Central Compartment Neck Dissection",{"label":18,"type":10,"description":11,"interventionNames":11},"Thyroid Lobectomy",{"label":20,"type":14,"description":11,"interventionNames":21},"Thyroid Lobectomy + ipCCND",[22],"Procedure: Thyroid Lobectomy + ipCCND",[24,29],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"PROCEDURE","Total Thyroidectomy + Central Compartment Neck Dissection","Thyroidectomy will be performed with the patient in the supine position with the neck hyperextended. A 3 to 6 cm transverse cervicotomy, two fingers above the sternal notch, will be performed, and the midline will be opened. After the inferior laryngeal nerve and parathyroids are visualized, the thyroidectomy will be achieved.\n\nWhen performed, pCCND will aim at removing the nodes of Level VI, which has been reported to contain the thyroid gland and the adjacent nodes bordered superiorly by the hyoid bone, inferiorly by the brachiocephalic artery, and laterally on each side by the carotid sheaths",[13],{"type":25,"name":20,"description":30,"armGroupLabels":31,"otherNames":11},"Thyroid lobectomy will be performed with the patient in the supine position with the neck hyperextended. A 3 to 6 cm transverse cervicotomy, two fingers above the sternal notch, will be performed, and the midline will be opened. After identification and preservation of the inferior laryngeal nerve and parathyroid glands, thyroid lobectomy will be completed on the affected side.\n\nWhen performed, ipsilateral prophylactic central compartment neck dissection will aim at removing the lymph nodes of Level VI on the operated side, which includes the prelaryngeal, pretracheal, and ipsilateral paratracheal lymph nodes. The central compartment is bordered superiorly by the hyoid bone, inferiorly by the brachiocephalic artery, and laterally by the carotid sheath on the ipsilateral side.",[20],{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Leonardo Rossi","Senior Researcher in General Surgery","100585206","the-role-of-prophylactic-central-compartment-neck-dissection-in-the-management-of-2-to-4-cm-papillary-thyroid-carcinoma-100585206",false,"NCT06899347","The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 cm Papillary Thyroid Carcinoma","Impact of PROphylactic Central cOMpArtment Neck Dissection for 2-4 cm Papillary Thyroid Carcinoma","PRO-COMAND","Inclusion criteria:\n\n1. PTC documented by fine needle aspiration cytology (FNAC) (TIR 4 or TIR 5 according to the Italian consensus for the classification and reporting of thyroid cytology \\[16\\]);\n2. patients scheduled for thyroid lobectomy or total thyroidectomy;\n3. no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);\n4. no clinical evidence of distant metastasis at diagnosis;\n5. age ≥ 18 years;\n6. signing informed consent.\n\nExclusion criteria:\n\n1. histotypes other than PTC;\n2. evidence of lymph node metastases during surgery even if not previously diagnosed;\n3. presence of distant metastasis;\n4. refusal to sign informed consent.\n\nExit criteria:\n\n1. withdrawal of informed consent;\n2. post-operative radioactive iodine therapy.","ALL","18 Years",{"count":47,"type":48},392,"ESTIMATED","INTERVENTIONAL",[51],"NA","Papillary thyroid carcinoma (PTC) is the most common endocrine malignancy and is frequently associated with microscopic central neck lymph node metastases, even in the absence of preoperative clinical evidence of nodal involvement (cN0). While prophylactic central compartment neck dissection (pCCND) may improve staging accuracy and potentially reduce disease persistence or recurrence, its routine use remains controversial due to the risk of increased surgical morbidity and potential negligible impact on oncologic outcomes.\n\nThis prospective randomized study aims to evaluate the oncological and surgical outcomes of cN0 PTC patients with tumors measuring 2 to 4 cm who undergo thyroid surgery with or without pCCND. Patients will be treated according to standard clinical practice with either total thyroidectomy (TT) or thyroid lobectomy (TL), and randomized to receive pCCND (bilateral or ipsilateral, respectively) or not. Patients undergoing TT and those undergoing TL will be analyzed separately in two parallel cohorts.\n\nThe primary objective is to assess the impact of pCCND on disease persistence or recurrence during long-term follow-up. Secondary objectives include evaluation of surgical complications and the impact of pCCND on pathological staging.",[54,55,56,18],"Papillary Thyroid Carcinoma","Central Compartment Neck Dissction","Thyroidectomy",[58,59,60,61,62,63],"papillary thyroid carcinoma","prophylactic central compartment neck dissection","thyroidectomy","surgical complications","outcomes","thyroid lobectomy","NOT_YET_RECRUITING","2026-04-28",{"date":67,"type":68},"2026-05-05","ACTUAL",{"date":65,"type":48},{"date":71,"type":48},"2036-04",{"name":34,"class":6}]