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

Seoul National University

Status: Completed

Conditions: Thyroid Cancer, Papillary

Treatments: Procedure: prophylactic central lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT02418390

H-1404-050-571

Details and patient eligibility

About

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

Full 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).

Enrollment: 101 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

No prophylactic central dissection

No Intervention group

Description:

Patients underwent total thyroidectomy for papillary thyroid carcinoma, without prophylactic central lymph node dissection

Prophylactic central dissection

Active Comparator group

Description:

Patients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection

Treatment:

Procedure: prophylactic central lymph node dissection