A Phase 2/3 interventional study of Routine central neck dissection in Carcinoma, sponsored by Samsung Medical Center. Status unknown at 1 site in South Korea. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-21.
Sponsored by Samsung Medical Center · Phase 2/3, Interventional, and Treatment
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.
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.
6,719 studies on the registry are indexed under Carcinoma; 1,142 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 45 across 5,153 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
Routine central neck dissection
Procedure: Routine central neck dissection
No central neck node dissection
Level VI neck node dissection during thyroid operation
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.
Time frame: Until 5 year follow-up. (Dec. 2016)
The efficacy of sentinel lymph node biopsy in micro PTC
Time frame: Until 5 year follow-up. (Dec. 2016)
Plan to share: No
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This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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