Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439745
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-03-07
Brief Title:
More Than 50 of the Patients With Clinically Unifocal T1bSmall T2 Node Negative Papillary Thyroid Carcinoma Scheduled for Thyroid Lobectomy May Require Completion Thyroidectomy if the Nodal Status is Evaluated
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
More Than 50 of the Patients With Clinically Unifocal T1bSmall T2 Node Negative Papillary Thyroid Carcinoma Scheduled for Thyroid Lobectomy May Require Completion Thyroidectomy if the Nodal Status is Evaluated
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
cN0PTC
Brief Summary:
In absence of nodal metastases or aggressive features thyroid lobectomy TL should be preferred over total thyroidectomy TT for small unifocal papillary thyroid carcinomaPTC 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 26 TL plus ipsilateral central neck dissections I-CND were scheduled for unifocal cT1bsmall 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
Among 4216 thyroidectomies for malignancy 2014-2023 110 26 TL plus ipsilateral central neck dissections I-CND were scheduled for unifocal cT1bsmall 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
Detailed 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 cT1bT2 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 cT1bsmall 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 age18 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
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 cT1bT2 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 cT1bsmall 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 age18 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None