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

June 2, 2010
April 20, 2016
June 2009
January 2011   (final data collection date for primary outcome measure)
The usefulness of lateral sentinel lymph node biopsy in PTC [ Time Frame: at Oct 2011 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01137097 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC
Value of Sentinel Lymph Node Biopsy to Lateral Neck Lymph Node in Thyroid Carcinoma: Prospective Study

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thyroid Neoplasm
Procedure: Lateral sentinel lymph node biopsy
Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively
  • Active Comparator: Lateral sentinel group
    Lateral sentinel lymph node biopsy with radioisotope
    Intervention: Procedure: Lateral sentinel lymph node biopsy
  • No Intervention: No intervention for lateral neck
    No lateral sentinel lymph node biopsy with radioisotope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01137097
2009-07-101
Yes
No
Not Provided
Jee soo Kim, Samsung Medical Center
Samsung Medical Center
Not Provided
Study Director: Se Kyung Lee, M.D Samsung Medical Center
Samsung Medical Center
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP