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.

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer, Papillary
• Intervention / Treatment: Procedure: prophylactic central lymph node dissection

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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)	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

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Kyu Eun Lee, MD, PhD, Seoul National University College of Medicine

Publications and helpful links

General Publications

• Carling T, Carty SE, Ciarleglio MM, Cooper DS, Doherty GM, Kim LT, Kloos RT, Mazzaferri EL Sr, Peduzzi PN, Roman SA, Sippel RS, Sosa JA, Stack BC Jr, Steward DL, Tufano RP, Tuttle RM, Udelsman R; American Thyroid Association Surgical Affairs Committee. American Thyroid Association design and feasibility of a prospective randomized controlled trial of prophylactic central lymph node dissection for papillary thyroid carcinoma. Thyroid. 2012 Mar;22(3):237-44. doi: 10.1089/thy.2011.0317. Epub 2012 Feb 7.

Study record dates

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: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Thyroid Diseases; Thyroid Neoplasms; Thyroid Cancer, Papillary
• Other Study ID Numbers: H-1404-050-571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO