A Randomized Controlled Clinical Trial: No Clear Benefit to Prophylactic Central Neck Dissection in Patients With Clinically Node Negative Papillary Thyroid Cancer

Abstract

Objective: The aim of this prospective randomized-controlled trial was to evaluate the risks/benefits of prophylactic central neck dissection (pCND) in patients with clinically node negative (cN0) papillary thyroid cancer (PTC).

Background: Microscopic lymph node involvement in patients with PTC is common, but the optimal management is unclear.

Methods: Sixty patients with cN0 PTC were randomized to a total thyroidectomy (TT) or a TT+ pCND. All patients received postoperative laryngoscopies and standardized radioiodine treatment. Thyroglobulin (Tg) levels and/or neck ultrasounds were performed at 6 weeks, 6 months, and 1 year.

Results: Tumors averaged 2.2 ± 0.2 cm and 11.9% had extra-thyroidal extension. Thirty patients underwent a pCND and 27.6% had positive nodes (all ≤6 mm). Rates of postoperative PTH < 10 (33.3% vs 24.1%, P = 0.57) and transient nerve dysfunction (13.3% vs 10.3%, P = 1.00) were not significantly different between groups. Six weeks after surgery, both TT and TT + pCND were equally likely to achieve a Tg < 0.2 (54.5% vs 66.7%, P = 0.54) and/or a stimulated Tg (sTg) <1 (59.3% vs 64.0%, P = 0.78). At 1 year, rates of Tg < 0.2 (88.9% vs 90.0%, P = 1.00) and sTg < 1 (93.8% vs 92.3%, P = 1.00) remained similar between groups. Neck ultrasounds at 1 year were equally likely to be read as normal (85.7% in TT vs 85.1% in pCND, P = 1.00).

Conclusions: cN0 PTC patients treated either with TT or TT + pCND had similar complication rates after surgery. Although microscopic nodes were discovered in 27.6% of pCND patients, oncologic outcomes were comparable at 1 year.

Trial registration: ClinicalTrials.gov NCT02138214.

FIGURE 1

CONSORT Diagram

FIGURE 2

Complication rates between treatment groups. * No significant differences between groups

FIGURE 3

Short term cancer outcomes between treatment groups. There were no significant differences between groups on any of the measured outcomes.

FIGURE 4

Groups categorized by the American Thyroid Association (ATA) Response to Initial Therapy

FIGURE 5A and 5B

(5A) Global QOL EORTC for treatment groups over time compared to the global health status mean for the general population. (5B) QOL as measured by the THYCa-QOL for treatment groups overtime. Data was collected at specified time points on the x-axis, lines are to demonstrate trends over-time for each cohort.

FIGURE 5A and 5B

(5A) Global QOL EORTC for treatment groups over time compared to the global health status mean for the general population. (5B) QOL as measured by the THYCa-QOL for treatment groups overtime. Data was collected at specified time points on the x-axis, lines are to demonstrate trends over-time for each cohort.