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The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.
The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Primary outcome is the surgical completeness, recurrence rate, and successful ablation rate. Secondary outcomes are the incidence of postoperative complications and PTC stage. The enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No prophylactic central dissection | No Intervention | Patients underwent total thyroidectomy for papillary thyroid carcinoma, without prophylactic central lymph node dissection | |
| Prophylactic central dissection | Active Comparator | Patients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prophylactic central lymph node dissection | Procedure | dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with successful surgical completeness | In the case of patients undergoing RAI ablation, surgical completeness was defined as cases with a negative ultrasonographic finding with postoperative 1st stimulated Tg <1 ng/mL. In patients who did not undergo RAI treatment, the case with a negative finding at the 1st postoperative ultrasound with postoperative 1st unstimulated Tg <0.2ng/mL was defined as surgical completeness. | Participants will be followed from the operation to 5 year (maximum) |
| Recurrence rate of thyroid cancer | Recurrence was defined according to the definition of response to therapy in the 2015 American Thyroid Association(ATA) guidelines. | Participants will be followed from the operation to 5 year (maximum) |
| Number of participants with successful ablation | Successful ablation was defined as a patient whose stimulated Tg level was measured as <1 ng/mL at last ablation. | Participants will be followed from the operation to 5 year (maximum) |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complication occurrence rate | At outpatient clinic (6months posteoperatively), video laryngoscopic exam and serum parathyroid hormone with serum calcium will be measured. Type and number of complications will be recorded | Participants will be followed from the operation to 5 year (maximum) |
| impact of prophylactic central lymph node dissection on staging of papillary thyroid cancer(PTC) |
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Inclusion criteria were as follows:
Exclusion criteria were as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu Eun Lee, MD, PhD | Seoul National University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22313454 | Result | Carling T, Carty SE, Ciarleglio MM, Cooper DS, Doherty GM, Kim LT, Kloos RT, Mazzaferri EL Sr, Peduzzi PN, Roman SA, Sippel RS, Sosa JA, Stack BC Jr, Steward DL, Tufano RP, Tuttle RM, Udelsman R; American Thyroid Association Surgical Affairs Committee. American Thyroid Association design and feasibility of a prospective randomized controlled trial of prophylactic central lymph node dissection for papillary thyroid carcinoma. Thyroid. 2012 Mar;22(3):237-44. doi: 10.1089/thy.2011.0317. Epub 2012 Feb 7. |
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| ID | Term |
|---|---|
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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Postoperative complications was divided into transient complication (< 6 months) and permanent complication (≥ 6 months) according to the duration. Hypoparathyroidism was diagnosed when patients were given oral calcium supplements to relieve symptoms of hypocalcemia or when serum parathyroid hormone (PTH) levels were lower than baseline values;1) PTH <10 pg/mL on days 1 and 14 after surgery; and 2) PTH <15 pg/mL at least 3 months after surgery. All patients underwent a laryngeal ultrasound or laryngoscope after surgery to check for RLN injury. RLN injury was diagnosed when the vocal cord movement was hypomobile or fixed on evaluation. In addition, present study evaluated symptoms related to voice changes, such as hoarseness, thickened voice, difficulty in making high pitch sound, easy voice fatigue, aspiration, or dyspnea in an outpatient clinic. |
| TNM stage of each case was confirmed after final pathologic reports. At our facility, final pathologic reports would be turned out at an average of 2 weeks after surgery |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |