The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 cm Papillary Thyroid Carcinoma (PRO-COMAND)
Impact of PROphylactic Central cOMpArtment Neck Dissection for 2-4 cm Papillary Thyroid Carcinoma
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Total Thyroidectomy
|
|
|
Experimental: Total Thyroidectomy + pCCND
|
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 |
|
No Intervention: Thyroid Lobectomy
|
|
|
Experimental: Thyroid Lobectomy + ipCCND
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
from enrollment to 1, 3, 5 and 10 years
|
|
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.
|
from the enrollment to 1, 3, 5, and 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical Complications
Time Frame: from enrollment to 1, 3, 5 and 10 years
|
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.
|
from enrollment to 1, 3, 5 and 10 years
|
|
Staging disease
Time Frame: from enrollment to 1, 3, 5 and 10 years
|
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).
|
from enrollment to 1, 3, 5 and 10 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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