NCT06899347Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 392 (estimated)
- First submitted
- 13 Mar 2025
- Start date
- 28 Apr 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- Leonardo Rossi
- Diseases
- Thyroid cancer
- NCT number
- NCT06899347
What you commit to
- Study type: Interventional
- Planned participants: 392
- From 28 Apr 2026 to the primary completion date, Apr 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- evidence of lymph node metastases during surgery even if not previously diagnosed;
- post-operative radioactive iodine therapy.
Other
- histotypes other than PTC;
- presence of distant metastasis;
- refusal to sign informed consent.
- Exit criteria:
- withdrawal of informed consent;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.