Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study
1 other identifier
interventional
2,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 21, 2016
April 1, 2016
8.6 years
June 2, 2010
April 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Is routine neck node dissection necessary in micro PTC?
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.
Until 5 year follow-up. (Dec. 2016)
Secondary Outcomes (1)
The efficacy of sentinel lymph node biopsy in micro PTC
Until 5 year follow-up. (Dec. 2016)
Study Arms (2)
C group
ACTIVE COMPARATORRoutine central neck dissection
N group
NO INTERVENTIONNo central neck node dissection
Interventions
Level VI neck node dissection during thyroid operation
Eligibility Criteria
You may qualify if:
- papillary carcinoma of thyroid (less than 4cm)
- no evidence of lymph node metastasis in preoperative work-up result
- the patients who accept this study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jee Soo Kim, M.D., Ph.D.
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 23, 2010
Study Start
May 1, 2009
Primary Completion
December 1, 2017
Study Completion
December 1, 2020
Last Updated
April 21, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share