Intraoperative Pathologic Evaluation of Central Lymph Nodes in Papillary Thyroid Carcinoma

Completed

• Conditions: Thyroid Cancer, Papillary

• Registration Number: NCT07066644
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-10-31
• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-04
• Study First Posted: 2025-07-15
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the accuracy of IOPE	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 Outcome Measures

Name	Time	Method
the incidence of complications in IOPE [safety of IOPE]	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
the risk factors for central lymph node metastasis	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of