Papillary Thyroid CarcinomaPRO-COMANDNCT06899347
The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 cm Papillary Thyroid Carcinoma
A study testing Total Thyroidectomy + Central Compartment Neck Dissection and Thyroid Lobectomy + ipCCND in people with Papillary Thyroid Carcinoma and Central Compartment Neck Dissction, run by Leonardo Rossi.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Carcinoma, Central Compartment Neck Dissction, Thyroidectomy
- What is being tested?
- Total Thyroidectomy + Central Compartment Neck Dissection and Thyroid Lobectomy + ipCCND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2026to Apr 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Papillary Thyroid Carcinoma, Central Compartment Neck Dissction, Thyroidectomy, Thyroid Lobectomy
- Being tested
- Total Thyroidectomy + Central Compartment Neck Dissection, Thyroid Lobectomy + ipCCND
- Keywords
- papillary thyroid carcinoma, prophylactic central compartment neck dissection, thyroidectomy, surgical complications, outcomes, thyroid lobectomy
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Thyroidectomy + Central Compartment Neck DissectionProcedure or surgery
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 + ipCCNDProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Total Thyroidectomy | No intervention | Not described |
| Total Thyroidectomy + pCCND | Experimental | Not described Receives: Procedure: Total Thyroidectomy + Central Compartment Neck Dissection |
| Thyroid Lobectomy | No intervention | Not described |
| Thyroid Lobectomy + ipCCND | Experimental | Not described Receives: Procedure: Thyroid Lobectomy + ipCCND |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from the enrollment to 1, 3, 5, and 10 years
Secondary outcomes (2)
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.
Measured: 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).
Measured: from enrollment to 1, 3, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start28 Apr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leonardo Rossi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leonardo Rossi, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899347
- Sponsor's protocol ID
- 27092
- Acronym
- PRO-COMAND
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2025
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PROphylactic Central cOMpArtment Neck Dissection for 2-4 cm Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT06899347
- Acronym / sponsor ID
- PRO-COMAND / 27092
- Conditions
- Papillary Thyroid Carcinoma, Central Compartment Neck Dissction, Thyroidectomy, Thyroid Lobectomy
- Keywords
- papillary thyroid carcinoma, prophylactic central compartment neck dissection, thyroidectomy, surgical complications, outcomes, thyroid lobectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Leonardo RossiUniversity, hospital or other
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2036 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total Thyroidectomy | No intervention | – |
| Total Thyroidectomy + pCCND | Experimental | Procedure: Total Thyroidectomy + Central Compartment Neck Dissection |
| Thyroid Lobectomy | No intervention | – |
| Thyroid Lobectomy + ipCCND | Experimental | Procedure: Thyroid Lobectomy + ipCCND |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
- withdrawal of informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Thyroidectomy + Central Compartment Neck DissectionThyroidectomy 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 | Procedure or surgery | Total Thyroidectomy + pCCND |
| Thyroid Lobectomy + ipCCNDThyroid 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. | Procedure or surgery | Thyroid Lobectomy + ipCCND |
Primary outcome
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.
2 secondary outcomes
Surgical Complications
Time frame: from enrollment to 1, 3, 5 and 10 years
Staging disease
Time frame: from enrollment to 1, 3, 5 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Total Thyroidectomy + Central Compartment Neck Dissection and Thyroid Lobectomy + ipCCND in people with Papillary Thyroid Carcinoma and Central Compartment Neck Dissction, run by Leonardo Rossi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma (time frame: from enrollment to 1, 3, 5 and 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.