Impact of PROphylactic Central cOMpArtment Neck Dissection for 2-4 cm Papillary Thyroid Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 392
- Primary Endpoint
- Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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]);
- •patients scheduled for thyroid lobectomy or total thyroidectomy;
- •no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);
- •no clinical evidence of distant metastasis at diagnosis;
- •age ≥ 18 years;
- •signing informed consent.
Exclusion Criteria
- •histotypes other than PTC;
- •evidence of lymph node metastases during surgery even if not previously diagnosed;
- •presence of distant metastasis;
- •refusal to sign informed consent.
- •Exit criteria:
- •withdrawal of informed consent;
- •post-operative radioactive iodine therapy.
Arms & Interventions
Total Thyroidectomy
Total Thyroidectomy + pCCND
Intervention: Total Thyroidectomy + Central Compartment Neck Dissection (Procedure)
Thyroid Lobectomy
Thyroid Lobectomy + ipCCND
Intervention: Thyroid Lobectomy + ipCCND (Procedure)
Outcomes
Primary Outcomes
Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma
Time Frame: from enrollment to 1, 3, 5 and 10 years
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.
Overall Survival
Time Frame: from the enrollment to 1, 3, 5, and 10 years
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.
Secondary Outcomes
- Surgical Complications(from enrollment to 1, 3, 5 and 10 years)
- Staging disease(from enrollment to 1, 3, 5 and 10 years)
Investigators
Leonardo Rossi
Senior Researcher in General Surgery
University of Pisa