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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2020-10-08

Brief Summary

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

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Detailed Description

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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).

Conditions

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Thyroid Cancer, Papillary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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No prophylactic central dissection

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Prophylactic central dissection

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

Group Type ACTIVE_COMPARATOR

prophylactic central lymph node dissection

Intervention Type PROCEDURE

dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification

Interventions

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prophylactic central lymph node dissection

dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No