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Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study


Phase 2/Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Carcinoma

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Trial Information

Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study


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.


Inclusion Criteria:



- micro papillary carcinoma of thyroid (less than 1cm)

- no evidence of lymph node metastasis in preoperative work-up result

- the patients who accept this study

Exclusion Criteria:

- large thyroid cancer( > 1cm)

- morbid

- anticoagulation agent usage

- endoscopic or robotic thyroid operation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Outcome Measure:

Is routine neck node dissection necessary in micro PTC?

Outcome Description:

To see the necessity of routine neck node dissection in micro PTC, we will compare the recurrence rate and other complication (e.g. hoarseness and hypocalcemia) between group I(no dissection) and group III(routine dissection) after completion of study(after 5 year f/u). To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.

Outcome Time Frame:

Until 5 year follow-up. (Dec. 2016)

Safety Issue:

Yes

Authority:

Korea: Institutional Review Board

Study ID:

2009-02-017

NCT ID:

NCT01149161

Start Date:

May 2009

Completion Date:

December 2017

Related Keywords:

  • Carcinoma
  • neck dissection
  • sentinel lymph node
  • Carcinoma
  • Papillary
  • thyroid
  • dissection
  • Carcinoma

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