Thyroid Cancer, PapillaryNCT07066644
Intraoperative Pathologic Evaluation of Central Lymph Nodes in Papillary Thyroid Carcinoma
An observational study of Thyroid Cancer, Papillary, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Efficacy of Intraoperative pathologic evaluation of central lymph nodes Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Papillary
- What is being tested?
- central node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 509 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the patients with unilateral papillary thyroid cancer classified as cN0 and performed with Intraoperative pathologic evaluation
Who may be able to join
- patients with unilateral papillary thyroid cancer
- no evidence of lymph node metastasis (clinically N0)
- performed with Intraoperative pathologic evaluation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: Intraoperative Pathologic Evaluation of Central Lymph Nodes to Determine the Extent of Surgery in Papillary Thyroid Carcinoma : A Retrospective Cohort Study
Efficacy of Intraoperative pathologic evaluation of central lymph nodes
Read the 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.
- Conditions
- Thyroid Cancer, Papillary
- Being tested
- central node dissection
- Keywords
- central lymph node metastasis, intraoperative pathological evaluation
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central node dissectionProcedure or surgery
dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative
Secondary outcomes (2)
the incidence of complications in IOPE [safety of IOPE]
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
Measured: up to 6 months
the risk factors for central lymph node metastasis
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
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 May 2021
- Primary completion30 Apr 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid Cancer, PapillaryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Eun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066644
- Sponsor's protocol ID
- H-2309-109-1467
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25692116Bae 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.
PubMed 37891110
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pathologic Evaluation of Central Lymph Nodes to Determine the Extent of Surgery in Papillary Thyroid Carcinoma : A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07066644
- Acronym / sponsor ID
- H-2309-109-1467
- Conditions
- Thyroid Cancer, Papillary
- Keywords
- central lymph node metastasis, intraoperative pathological evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the patients with unilateral papillary thyroid cancer classified as cN0 and performed with Intraoperative pathologic evaluation
Key inclusion criteria (3 listed)
- patients with unilateral papillary thyroid cancer
- no evidence of lymph node metastasis (clinically N0)
- performed with Intraoperative pathologic evaluation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| central node dissectiondissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
the incidence of complications in IOPE [safety of IOPE]
Time frame: up to 6 months
the risk factors for central lymph node metastasis
Time frame: perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Results publication: PubMed 25692116Ahn 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.
- Results publication: PubMed 37891110Bae 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, Papillary, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the accuracy of IOPE (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07066644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.