Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06439745 |
| Other study ID # |
6584 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2014 |
| Est. completion date |
February 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
inclinically node-negative (cN0) PTC.
Among 4216 thyroidectomies for malignancy (2014-2023), 110 (2.6%) TL plus ipsilateral central
neck dissections (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.
Description:
Papillary thyroid carcinoma (PTC) is the most common type of thyroid cancer. Although its
incidence has increased in recent decades, the prognosis is excellent due to the indolent
nature of disease. Despite that, recurrence rate of PTC remains common. Nowadays, the correct
extent of thyroidectomy remains controversial. However, several studies demonstrated no
significant differences in terms of disease-free survival (DFS) and loco-regional recurrence
(LRR) in differentiated thyroid carcinoma (DTC) > 1cm after thyroid lobectomy (TL) vs thyroid
lobectomy (TT). In absence of preoperative high-risk features (HRFs), the most recent NCCN
and ATA guidelines consider unifocal 1-4 cm PTC eligible for TL. However, many of HRFs are
highlighted only after histological examination: positive lymph nodes, aggressive tumor
subtype, multifocality, microscopic extrathyroidal extension (ETE), positive margin and
lymphovascular invasion (LVI).
Recent retrospective series showed that up to 59% of preoperative low risk PCT were upgraded
to higher risk category after histological examination. Current recommendations could
potentially increase the need for reoperation, in terms of completion thyroidectomy (CT) and
subsequent administration of RAI in order to reduce the risk of LRR. Among the HRFs, no
preoperative clinical parameter is a predictor of nodal disease. However, occult lymph node
metastases (LNMs) may be found in 31-62% of patients subjected to prophylactic CND (p-CND).
The risk of complications (hypoparathyroidism and laryngeal nerve injury) is the main matter
against prophylactic bilateral CND in unifocal node negative PCT. According to a recent
systematic review, basing on prevalence of occult central LNM by tumor size, ipsilateral
central neck dissection (I-CND) may be justified in all PTC patients. Since isolated
contralateral metastases are rare, a routine use of frozen section examination (FSE) of I-CND
may allow a more accurate staging with a reduction of morbidity. Although p-CND is not
usually recommended in patients with clinically unifocal cT1b/T2 node negative PTC, we
supposed that the evaluation of LN status through FSE of I-CND may contribute significantly
to risk stratification and consequently to modulate the extension of surgical treatment.
In this retrospective study we aim to evaluate the result of this strategy to identify
intraoperatively patients who may benefit from total thyroidectomy (TT) with bilateral CND
(B-CND), reducing the need of second step CT and, theoretically, the risk of LRR.
Among 4176 patients who underwent thyroidectomy for malignancy between September 2014 and
September 2023 at Fondazione Policlinico Universitario A. Gemelli - Rome, we identified X
patients scheduled for thyroid lobectomy (TL) plus ipsilateral central neck dissection
(I-CND) for clinically intrathyroidal unifocal cT1b/small cT2 node negative papillary thyroid
carcinoma (PTC). Every patient was informed of the risks and benefits of TL and TT, based on
available guidelines.
Inclusion criteria were: 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.
Exclusion criteria were: age < 18 years; prior head or neck irradiation; family history of
thyroid carcinoma; clinical evidence of multifocality, extrathyroidal extension or LN
metastases; follow-up < 6 months.
