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Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01137097
First received: June 2, 2010
Last updated: July 21, 2011
Last verified: July 2011

June 2, 2010
July 21, 2011
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
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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.

Not Provided
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
    Sentinel lymph node biopsy with radioisotope. The number of patients: 139
    Intervention: Procedure: Lateral sentinel lymph node biopsy
  • No Intervention: No intervention for lateral neck
    The number of patients: 139
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
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01137097
2009-07-101
Yes
Jee Soo Kim/ Associate professor, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
July 2011

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