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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

101

Phase

  • 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

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
Intervention / Treatment
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

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

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

Seoul National University Hospital

Investigators

  • 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)

April 1, 2015

Primary Completion (Actual)

October 8, 2020

Study Completion (Actual)

October 8, 2020

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 12, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Subscribe