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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
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated 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
Sentinel lymph node biopsy with radioisotope. The number of patients: 139
 Procedure: Lateral sentinel lymph node biopsy
Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively
No Intervention: No intervention for lateral neck
The number of patients: 139

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137097

Locations
Korea, Republic of
Samsung Medical Center
Seoul, 50 Irwon-dong, Gangnam-gu, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jee Soo Kim/ Associate 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: July 21, 2011
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013