An interventional study of Total Thyroidectomy + Central Compartment Neck Dissection and Thyroid Lobectomy + ipCCND in Papillary Thyroid Carcinoma, Central Compartment Neck Dissction and Thyroidectomy, sponsored by Leonardo Rossi. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Leonardo Rossi · Not applicable, Interventional, and Treatment
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.
This 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.
The 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.
175 studies on the registry are indexed under Thyroid Cancer, Papillary; 52 are open to participants now.
This study's planned enrollment of 392 is above the median of 50 across 108 interventional studies indexed under Thyroid Cancer, Papillary.
Browse Thyroid Cancer, Papillary studies →This is the only study on the registry with Leonardo Rossi as lead sponsor.
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Exclusion criteria:
Exit criteria:
Procedure: Total Thyroidectomy + Central Compartment Neck Dissection
Procedure: Thyroid Lobectomy + ipCCND
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. When 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
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. When 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.
Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma
Persistent or recurrent disease refers to the presence or reappearance of cancerous tissue despite initial treatment. It is assessed through a combination of biochemical and imaging studies. Biochemically, elevated serum thyroglobulin (Tg) or detectable anti-thyroglobulin antibodies (TgAb) after total thyroidectomy may suggest residual or recurrent disease. Moreover, they may represent a biochemical incomplete or indeterminate response to therapy. On the other hand, imaging techniques such as neck ultrasound or CT scan can identify structural disease.
Time frame: from enrollment to 1, 3, 5 and 10 years
Overall Survival
Overall survival is the most comprehensive indicator of treatment efficacy and patient prognosis. It is typically assessed through survival analysis methods, such as Kaplan-Meier curves, and is expressed as a percentage of patients alive at specific time points.
Time frame: from the enrollment to 1, 3, 5, and 10 years
Surgical Complications
Complications following thyroidectomy are mainly hypoparathyroidism, vocal cord palsy and bleeding. They are assessed through clinical evaluation, laboratory tests (e.g., calcium and PTH levels for hypoparathyroidism), and laryngoscopy and / or transcutaneous laryngeal ultrasound for vocal cord function.
Time frame: from enrollment to 1, 3, 5 and 10 years
Staging disease
Disease staging will be performed according to the AJCC/TNM system (8th edition) for papillary thyroid carcinoma, assessing tumor size (T), regional lymph node involvement (N), and presence of distant metastases (M); moreover, it will be assessed even according to the latest ATA guidelines (low; low-intermediate; intermediate-high; high).
Time frame: from enrollment to 1, 3, 5 and 10 years
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Plan to share: Undecided
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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