Intraoperative Pathologic Evaluation of Central Lymph Nodes in Papillary Thyroid Carcinoma

NCT07066644 | Completed DMC

• 1 other identifier: H-2309-109-1467
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of Intraoperative pathologic evaluation of central lymph nodes

Conditions

Thyroid Cancer, Papillary

Keywords

central lymph node metastasis; intraoperative pathological evaluation

Outcome Measures

Primary Outcomes (1)

• the accuracy of IOPE

  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.

  Perioperative

Secondary Outcomes (2)

• the incidence of complications in IOPE [safety of IOPE]

  up to 6 months

• the risk factors for central lymph node metastasis

  perioperative

Interventions

central node dissection PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patients with unilateral papillary thyroid cancer classified as cN0 and performed with Intraoperative pathologic evaluation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Related Publications (2)

• Ahn BH, Kim JR, Jeong HC, Lee JS, Chang ES, Kim YH. Predictive factors of central lymph node metastasis in papillary thyroid carcinoma. Ann Surg Treat Res. 2015 Feb;88(2):63-8. doi: 10.4174/astr.2015.88.2.63. Epub 2015 Jan 27.

  PMID: 25692116 RESULT

• Bae HL, Ahn JH, Kwak J, Kim HS, Yoon SG, Yi JW, Kim SJ, Lee KE. Intraoperative pathologic evaluation of central compartment lymph nodes in patients undergoing lobectomy for unilateral papillary thyroid carcinoma. Asian J Surg. 2024 Jan;47(1):360-366. doi: 10.1016/j.asjsur.2023.08.203. Epub 2023 Oct 25.

  PMID: 37891110 RESULT

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 15, 2025
• Study Start: May 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: October 31, 2023
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)