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Completed

NCT Number: NCT02418390

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

The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

were as follows:

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

Exclusion criteria

were as follows:

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

Treatment and study plan

Prophylactic central lymph node dissection

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2015
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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