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Intraoperative Pathologic Evaluation of Central Lymph Nodes in Papillary Thyroid Carcinoma

Intraoperative Pathologic Evaluation of Central Lymph Nodes to Determine the Extent of Surgery in Papillary Thyroid Carcinoma : A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07066644
Enrollment
509
Registered
2025-07-15
Start date
2021-05-01
Completion date
2023-10-31
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer, Papillary

Keywords

central lymph node metastasis, intraoperative pathological evaluation

Brief summary

Efficacy of Intraoperative pathologic evaluation of central lymph nodes

Detailed description

This study aimed to evaluate the effectiveness of intraoperative pathological examination and determine the risk factors for central lymph node metastasis in patients with unilateral clinically node-negative (cN0) papillary thyroid carcinoma.

Interventions

PROCEDUREcentral node dissection

dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patients with unilateral papillary thyroid cancer * no evidence of lymph node metastasis (clinically N0) * performed with Intraoperative pathologic evaluation

Exclusion criteria

* those with a history of neck surgery * those with lateral lymph node metastasis * those with suspected extrathyroidal extension * those in whom Intraoperative pathologic evaluation was not performed

Design outcomes

Primary

MeasureTime frameDescription
the accuracy of IOPEPerioperativeTo evaluate IOPE accuracy, the findings were compared with the final pathology results, utilizing key parameters such as sensitivity, specificity, false-negative rate (FNR), and false-positive rate for analysis.

Secondary

MeasureTime frameDescription
the incidence of complications in IOPE [safety of IOPE]up to 6 monthsThe safety was evaluated by examining the incidence of complications, including vocal cord palsy and hypoparathyroidism. vocal cord palsy : measured by laryngeal sono hypoparathyroidism : serum parathyroid hormone levels \< 15.0 pg/mL
the risk factors for central lymph node metastasisperioperativeTo determine the risk factors for central lymph node metastasis, univariate and multivariate logistic regression analyses were performed to identify the correlations between clinicopathological characteristics and the final pathological presence of central lymph node metastasis. clinicopathological factors : sex, age (\<55, ≥55), sonographic features, size (\<1cm, ≥1cm) presence of central lymph node metastasis was confirmed by final pathology

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026