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Completed

NCT Number: NCT07066644

Intraoperative Pathologic Evaluation of Central Lymph Nodes in Papillary Thyroid Carcinoma

Efficacy of Intraoperative pathologic evaluation of central lymph nodes

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Key information

Conditions

Thyroid Cancer, Papillary Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Diseases Thyroid Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

central node dissection

Procedure

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

Primary outcomes

  1. the accuracy of IOPE

    Time frame: Perioperative

    To 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 outcomes

  1. the incidence of complications in IOPE [safety of IOPE]

    Time frame: up to 6 months

    The 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

  2. the risk factors for central lymph node metastasis

    Time frame: perioperative

    To 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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