Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

NCT ID: NCT01137097

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-01-31

Brief Summary

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

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.

Conditions

Thyroid Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lateral sentinel group

Lateral sentinel lymph node biopsy with radioisotope

Group Type: ACTIVE_COMPARATOR

Lateral sentinel lymph node biopsy

Intervention Type: PROCEDURE

Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively

No intervention for lateral neck

No lateral sentinel lymph node biopsy with radioisotope

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lateral sentinel lymph node biopsy

Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jee soo Kim

Association professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Se Kyung Lee, M.D

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2009-07-101

Identifier Type: -

Identifier Source: org_study_id