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

Thyroid Cancer, Papillary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418390
• Other study ID #: H-1404-050-571
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: October 8, 2020

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• prophylactic central lymph node dissection
dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. Am — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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