The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma

May 30, 2022 updated by: Kyu Eun Lee, Seoul National University Hospital
The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Primary outcome is the surgical completeness, recurrence rate, and successful ablation rate. Secondary outcomes are the incidence of postoperative complications and PTC stage. The enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria were as follows:

  1. patients aged 20 to 70 years old
  2. patients diagnosed with PTC or suspicious for PTC on fine needle aspiration or core needle biopsy
  3. patients with no evidence of LNM before and during surgery(cN0)
  4. patients with no evidence of distant metastasis(cM0).

Exclusion criteria were as follows:

  1. patients suspected of advanced PTC(clinically T3 or T4) such as invasion of peripheral organs on preoperative examination
  2. patients who have previous history of cervical radiation therapy or surgery.
  3. pregnant women
  4. uncontrolled diabetes, hypertension, or chronic renal failure
  5. aspirin or anticoagulant medication within 7 days
  6. other clinical trial participation within 30 days
  7. radiation exposure to the head and neck
  8. previous operation to the neck
  9. advanced thyroid cancer including adjacent organ invasion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No prophylactic central dissection
Patients underwent total thyroidectomy for papillary thyroid carcinoma, without prophylactic central lymph node dissection
Active Comparator: Prophylactic central dissection
Patients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection
Procedure: prophylactic central lymph node dissection
dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of participants with successful surgical completeness
Time Frame: Participants will be followed from the operation to 5 year (maximum)

In the case of patients undergoing RAI ablation, surgical completeness was defined as cases with a negative ultrasonographic finding with postoperative 1st stimulated Tg <1 ng/mL.

In patients who did not undergo RAI treatment, the case with a negative finding at the 1st postoperative ultrasound with postoperative 1st unstimulated Tg <0.2ng/mL was defined as surgical completeness.
Participants will be followed from the operation to 5 year (maximum)
Recurrence rate of thyroid cancer
Time Frame: Participants will be followed from the operation to 5 year (maximum)
Recurrence was defined according to the definition of response to therapy in the 2015 American Thyroid Association(ATA) guidelines.
Participants will be followed from the operation to 5 year (maximum)
Number of participants with successful ablation
Time Frame: Participants will be followed from the operation to 5 year (maximum)
Successful ablation was defined as a patient whose stimulated Tg level was measured as <1 ng/mL at last ablation.
Participants will be followed from the operation to 5 year (maximum)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
postoperative complication occurrence rate
Time Frame: Participants will be followed from the operation to 5 year (maximum)
At outpatient clinic (6months posteoperatively), video laryngoscopic exam and serum parathyroid hormone with serum calcium will be measured. Type and number of complications will be recorded
Participants will be followed from the operation to 5 year (maximum)
impact of prophylactic central lymph node dissection on staging of papillary thyroid cancer(PTC)
Time Frame: TNM stage of each case was confirmed after final pathologic reports. At our facility, final pathologic reports would be turned out at an average of 2 weeks after surgery

Postoperative complications was divided into transient complication (< 6 months) and permanent complication (≥ 6 months) according to the duration.

Hypoparathyroidism was diagnosed when patients were given oral calcium supplements to relieve symptoms of hypocalcemia or when serum parathyroid hormone (PTH) levels were lower than baseline values;1) PTH <10 pg/mL on days 1 and 14 after surgery; and 2) PTH <15 pg/mL at least 3 months after surgery.

All patients underwent a laryngeal ultrasound or laryngoscope after surgery to check for RLN injury. RLN injury was diagnosed when the vocal cord movement was hypomobile or fixed on evaluation. In addition, present study evaluated symptoms related to voice changes, such as hoarseness, thickened voice, difficulty in making high pitch sound, easy voice fatigue, aspiration, or dyspnea in an outpatient clinic.
TNM stage of each case was confirmed after final pathologic reports. At our facility, final pathologic reports would be turned out at an average of 2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kyu Eun Lee, MD, PhD, Seoul National University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-1404-050-571

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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