Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
NCT ID: NCT00795782
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
258 participants
INTERVENTIONAL
2009-01-31
2014-06-30
Brief Summary
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Detailed Description
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Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings.
Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection.
Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study.
Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND)
Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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UniCND
Limited/ipsilateral central lymph node dissection
Prophylactic central lymph node dissection
prophylactic ipsilateral versus bilateral central lymph node dissection
BiCND
Comprehensive/bilateral central lymph node dissection
Prophylactic central lymph node dissection
prophylactic ipsilateral versus bilateral central lymph node dissection
NoCND
No central lymph node dissection
No interventions assigned to this group
Interventions
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Prophylactic central lymph node dissection
prophylactic ipsilateral versus bilateral central lymph node dissection
Eligibility Criteria
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Inclusion Criteria
* Sonographically node-negative cytology confirmed thyroid papillary carcinoma
* Tumor size less than 1 cm in sonography
* Tumor confined to the one lobe of the thyroid gland
* One who provides the informed consent
Exclusion Criteria
* History of other malignancy except thyroid cancer
* Poor performance status (ECOG 3-4)
18 Years
70 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Han-Sin Jeong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Son YI, Jeong HS, Baek CH, Chung MK, Ryu J, Chung JH, So YK, Jang JY, Choi J. Extent of prophylactic lymph node dissection in the central neck area of the patients with papillary thyroid carcinoma: comparison of limited versus comprehensive lymph node dissection in a 2-year safety study. Ann Surg Oncol. 2008 Jul;15(7):2020-6. doi: 10.1245/s10434-008-9928-8. Epub 2008 May 6.
Other Identifiers
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2008-09-048
Identifier Type: -
Identifier Source: org_study_id
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