Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Overview

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 Title of Study: “Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: December 2017

Detailed 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.

Interventions

  • Procedure: Routine central neck dissection
    • Level VI neck node dissection during thyroid operation

Arms, Groups and Cohorts

  • Active Comparator: C group
    • Routine central neck dissection
  • No Intervention: N group
    • No central neck node dissection

Clinical Trial Outcome Measures

Primary Measures

  • Is routine neck node dissection necessary in micro PTC?
    • Time Frame: Until 5 year follow-up. (Dec. 2016)
    • 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.

Secondary Measures

  • The efficacy of sentinel lymph node biopsy in micro PTC
    • Time Frame: Until 5 year follow-up. (Dec. 2016)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jee soo Kim, Associate professor – Samsung Medical Center
  • Overall Official(s)
    • Jee Soo Kim, M.D., Ph.D., Study Chair, Samsung Medical Center
  • Overall Contact(s)
    • Jee Soo Kim, M.D., Ph.D., 82-2-3410-3479, js0507.kim@samsung.com

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