More Than 50% of Unifocal cN0 T1b/Small T2 Papillary Thyroid Carcinoma May Require Completion Thyroidectomy if Nodal Status is Evaluated

NCT06439745 | Completed

• 1 other identifier: 6584
• Study Type: observational
• Target: 314
• Locations: 0 countries
• Sites: N/A

Brief Summary

In absence of nodal metastases or aggressive features, thyroid lobectomy (TL) should be preferred over total thyroidectomy (TT) for small unifocal papillary thyroid carcinoma (PTC). However, occult, despite non-microscopic (\>2 mm), nodal metastases may be present in clinically node-negative (cN0) PTCs. Among 4216 thyroidectomies for malignancy (2014-2023), 110 (2.6%) TL plus ipsilateral central neck dissection (I-CND) were scheduled for unifocal cT1b/small cT2 (\<3 cm) cN0 PTCs. Nodes frozen section examination (FSE) was performed: when positive, completion thyroidectomy (CT) was accomplished during the same procedure. In presence of aggressive pathologic features, CT was suggested within 6 months from index operation.

Conditions

Papillary Thyroid Cancer; Papillary Carcinoma; Thyroid Cancer; Thyroid Carcinoma; Thyroid Cancer, Papillary; Lymph Node Metastasis

Outcome Measures

Primary Outcomes (1)

• evaluation of patients requiring total thyroidectomy

  Evaluation of histopathologic risk factors in patients with papillary thyroid carcinoma, consisting of rate of nodal metastases, aggressive variants, lympho-angioinvasion, extranodal extension, multifocalty, positive resection status, in order to tailor surgical strategy (completion thyroidectomy)

  September 2014-September 2023

Secondary Outcomes (1)

• evaluation of disease recurrence

  September 2014-September 2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent surgical treatment of papillary thyroid carcinoma at the Surgical Division of Endocrine and Metabolic Surgery of Fondazione Policlinico Universitario A. Gemelli IRCCS between September 2014 and September 2023.

You may qualify if:

• age\>18
• classic papillary carcinoma and variants
• clinically unifocal and intrathyroidal PTC
• clinical tumor size \>1 cm and ≤3 cm
• no clinical evidence of LN involvement

You may not qualify if:

• age \< 18
• prior head or neck irradiation
• family history of thyroid carcinoma
• clinical evidence of multifocality
• extrathyroidal extension or LN metastases
• follow-up \< 6 months.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Carcinoma, Papillary; Thyroid Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplasms, Squamous Cell; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: June 3, 2024
• Study Start: September 1, 2014
• Primary Completion: September 1, 2023
• Study Completion: February 1, 2024
• Last Updated: September 2, 2025

Record last verified: 2024-03