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

Not Applicable

Completed

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

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).

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Prophylactic central dissection	prophylactic central lymph node dissection	Patients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection

Primary Outcome Measures

Name	Time	Method
Number of participants with successful ablation	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.
Recurrence rate of thyroid cancer	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.
The number of participants with successful surgical completeness	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.

Secondary Outcome Measures

Name	Time	Method
postoperative complication occurrence rate	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
impact of prophylactic central lymph node dissection on staging of papillary thyroid cancer(PTC)	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.

Locations (1): Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of

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