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Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC (LSLNB)

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ClinicalTrials.gov Identifier: NCT01137097
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Jee soo Kim, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Thyroid Neoplasm Procedure: Lateral sentinel lymph node biopsy Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Value of Sentinel Lymph Node Biopsy to Lateral Neck Lymph Node in Thyroid Carcinoma: Prospective Study
Study Start Date : June 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Lateral sentinel group
Lateral sentinel lymph node biopsy with radioisotope
Procedure: Lateral sentinel lymph node biopsy
Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively
No Intervention: No intervention for lateral neck
No lateral sentinel lymph node biopsy with radioisotope

Primary Outcome Measures :
  1. The usefulness of lateral sentinel lymph node biopsy in PTC [ Time Frame: at Oct 2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137097

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Study Director: Se Kyung Lee, M.D Samsung Medical Center

Responsible Party: Jee soo Kim, Association professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01137097     History of Changes
Other Study ID Numbers: 2009-07-101
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms