Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

Samsung Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Thyroid Neoplasm

Treatments: Procedure: Lateral sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01137097

2009-07-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 278 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

Lateral sentinel group

Active Comparator group

Description:

Lateral sentinel lymph node biopsy with radioisotope

Treatment:

Procedure: Lateral sentinel lymph node biopsy

No intervention for lateral neck

No Intervention group

Description:

No lateral sentinel lymph node biopsy with radioisotope