Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

NCT ID: NCT01149161

Last Updated: 2016-04-21

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2020-12-31

Brief Summary

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Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.

Detailed Description

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The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.

Conditions

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Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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C group

Routine central neck dissection

Group Type ACTIVE_COMPARATOR

Routine central neck dissection

Intervention Type PROCEDURE

Level VI neck node dissection during thyroid operation

N group

No central neck node dissection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Routine central neck dissection

Level VI neck node dissection during thyroid operation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* papillary carcinoma of thyroid (less than 4cm)
* no evidence of lymph node metastasis in preoperative work-up result
* the patients who accept this study

Exclusion Criteria

* large thyroid cancer( \> 4cm)
* morbid
* anticoagulation agent usage
* endoscopic or robotic thyroid operation
* evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jee soo Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jee Soo Kim, M.D., Ph.D.

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jee Soo Kim, M.D., Ph.D.

Role: CONTACT

82-2-3410-3479

Facility Contacts

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Jee Soo Kim, M.D., Ph.D.

Role: primary

82-2-3410-3479

Other Identifiers

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2009-02-017

Identifier Type: -

Identifier Source: org_study_id

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