Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

Study Overview
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Brief Summary
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Objective: To investigate the incidence of lateral neck node occult metastasis and to show the usefulness of sentinel lymph node biopsy (SLNB) in the detection of lateral neck node metastasis in thyroid carcinoma, the investigators used a radioisotope to detect the sentinel lymph node. Summary Background Data: Although occult lymph node metastasis to the lateral neck compartment is common in papillary thyroid carcinoma, the incidence and patterns of lateral neck node metastasis in papillary carcinoma are not known.

Detailed Description
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On the day of the operation, patients underwent preoperative lymphoscintigraphy after the intratumoral injection of a Tc-99m phytate 1 mCi in 0.1-0.2 mL 0.9% NaCl under ultrasonographic guidance. Total thyroidectomy or lobectomy with central neck dissection preceded SLN detection to avoid interference by primary tumor radioactivity. After total thyroidectomy or lobectomy, the dissections were performed toward the internal jugular chain beneath the sternocleidomastoid muscle. A handheld, collimated gamma probe and lymphoscintigraphy were used to scan the lateral compartments (through skin and under the SCM) for radioactive lymph nodes. Removed SLNs were submitted immediately for frozen biopsy. If any of the SLNs were positive for metastasis on the frozen sections, MRND was performed immediately. In cases for which the frozen section was negative but the final pathology report detailed microscopic positivity in the lateral sentinel nodes, RAI ablations were performed without additional MRND.

Official Title
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Value of Sentinel Lymph Node Biopsy to Lateral Neck Lymph Node in Thyroid Carcinoma: Prospective Study

Conditions
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Thyroid Neoplasm

Intervention / Treatment
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* Procedure: Lateral sentinel lymph node biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases with tumors larger than 1 cm in size or with suspicious central neck node metastasis in Papillary thyroid cancer Exclusion Criteria: The patient with definite metastatic lymph node in lateral neck compartment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lateral sentinel group<br>Lateral sentinel lymph node biopsy with radioisotope | Procedure: Lateral sentinel lymph node biopsy<br>* Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively<br>|
| No Intervention: No intervention for lateral neck<br>No lateral sentinel lymph node biopsy with radioisotope | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The usefulness of lateral sentinel lymph node biopsy in PTC |  | at Oct 2011 |