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Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma

Primary Purpose

Thyroid Neoplasm, Lymphatic Metastasis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

prophylactic selective lateral neck dissection

About this trial

This is an interventional diagnostic trial for Thyroid Neoplasm focused on measuring Papillary thyroid carcinoma with neck metastasis, neck dissection

Eligibility Criteria

20 Years - 76 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Papillary thyroid carcinoma with central neck metastasis
No evidence of lateral neck metastasis as determined by high-resolution neck ultrasonography and computed tomography

Exclusion Criteria:

History of previous thyroid operation
Isthmic thyroid lesion

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01103557

First Posted

April 12, 2010

Last Updated

April 13, 2010

Sponsor

Pusan National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01103557

Brief Title

Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma

Official Title

The Effectiveness of Prophylactic Selective Lateral Neck Dissection in Papillary Thyroid Carcinoma Patients With Central Neck Metastasis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Pusan National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to prospectively analyze the incidence of occult lateral neck metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck dissection (SND).

Detailed Description

The lymphatic drainage pattern of the thyroid is uniform and consistent, and therefore, metastatic patterns are relatively predictable. Initial nodal metastasis in PTC usually occurs in the paratracheal and pretracheal nodes in level VI of the central compartment of the ipsilateral neck and spreads to the lateral cervical lymph nodes. Macroscopic skip metastases to the lateral compartment of the neck in the absence of central disease are uncommon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Neoplasm, Lymphatic Metastasis

Keywords

Papillary thyroid carcinoma with neck metastasis, neck dissection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

prophylactic selective lateral neck dissection

Intervention Description

Level II, III, IV lymph node dissection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

76 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Papillary thyroid carcinoma with central neck metastasis No evidence of lateral neck metastasis as determined by high-resolution neck ultrasonography and computed tomography Exclusion Criteria: History of previous thyroid operation Isthmic thyroid lesion

12. IPD Sharing Statement

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Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma

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