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Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Samsung Medical Center logo

Samsung Medical Center

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Carcinoma

Treatments

Procedure: Routine central neck dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT01149161
2009-02-017

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2,000 participants in 2 patient groups

C group
Active Comparator group
Description:
Routine central neck dissection
Treatment:
Procedure: Routine central neck dissection
N group
No Intervention group
Description:
No central neck node dissection

Trial contacts and locations

1

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Central trial contact

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

Data sourced from clinicaltrials.gov

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