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The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.
The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UniCND | Experimental | Limited/ipsilateral central lymph node dissection |
|
| BiCND | Active Comparator | Comprehensive/bilateral central lymph node dissection |
|
| NoCND | No Intervention | No central lymph node dissection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic central lymph node dissection | Procedure | prophylactic ipsilateral versus bilateral central lymph node dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools) | 3 year after initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications(hypocalcemia, hoarseness) | up to 3 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han-Sin Jeong, MD, PhD | Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18459004 | Background | 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. |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |