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Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

This study is currently recruiting participants.
Verified June 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Jee soo Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01149161
First received: June 2, 2010
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Carcinoma
 Procedure: Routine central neck dissection
Procedure: Sentinel lymph node biopsy for central neck
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Is routine neck node dissection necessary in micro PTC? [ Time Frame: Until 5 year follow-up. (Dec. 2016) ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • The efficacy of sentinel lymph node biopsy in micro PTC [ Time Frame: Until 5 year follow-up. (Dec. 2016) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 801
Study Start Date: May 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No central neck dissection
No central neck intervention, Patient's Number of this group: 267
Active Comparator: Routine central neck node dissection Procedure: Routine central neck dissection
Level VI neck node dissection during thyroid operation for micro PTC. Patient's Number of this group: 267
Active Comparator: Sentinel lymph node biopsy for central neck Procedure: Sentinel lymph node biopsy for central neck
Sentinel lymph node biopsy with methylen blue. Peritumoral injection in operating room, Patient's Number of this group: 267

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149161

Contacts
Contact: Jee Soo Kim, M.D., Ph.D. 82-2-3410-3479 js0507.kim@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jee Soo Kim, M.D., Ph.D.     82-2-3410-3479        
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jee soo Kim, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01149161     History of Changes
Other Study ID Numbers: 2009-02-017
Study First Received: June 2, 2010
Last Updated: June 20, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
neck dissection
sentinel lymph node
Carcinoma
 Papillary
thyroid
dissection

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013