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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jee soo Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01137097
First received: June 2, 2010
Last updated: April 20, 2016
Last verified: April 2016
  Purpose

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 Intervention Phase
Thyroid Neoplasm
Procedure: Lateral sentinel lymph node biopsy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Value of Sentinel Lymph Node Biopsy to Lateral Neck Lymph Node in Thyroid Carcinoma: Prospective Study

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The usefulness of lateral sentinel lymph node biopsy in PTC [ Time Frame: at Oct 2011 ] [ Designated as safety issue: Yes ]

Enrollment: 278
Study Start Date: June 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01137097

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

Responsible Party: Jee soo Kim, Association professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01137097     History of Changes
Other Study ID Numbers: 2009-07-101 
Study First Received: June 2, 2010
Last Updated: April 20, 2016
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 01, 2016