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The Role of Sentinel Lymph Node Biopsy (SLNB) In the Management of Differentiated Thyroid Cancer

Phase 3
Not Enrolling
Thyroid Cancer, Lymph Node Metastasis

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Trial Information

The Role of Sentinel Lymph Node Biopsy (SLNB) In the Management of Differentiated Thyroid Cancer

The study includes 45 consecutive patients diagnosed as differentiated thyroid cancer by
clinical examination and/or fine needle aspiration cytology (FNAC).

Exclusion criteria are: previous neck surgery, pregnancy and known hypersensitivity to the
dye used.

An informed consent was obtained from all the patients. Peroperative workup includes history
taking, clinical examination, relevant laboratory investigations including thyroid hormone
assay, ultrasonography of the neck with special emphasis on the thyroid focal lesion and
cervical lymph nodes. FNAC was attempted in all patients.

All patients were then subjected to operation:

A systematized surgical approach was adopted for the purpose of the study: this started by
collar incision, development of sub-platysmal skin flaps and separation of strap muscles in
the midline. This was followed by exposure of the thyroid gland; identification of the
thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph
nodes; identifying the stained node; labeling it as the sentinel node (SLN); performing
total thyroidectomy and bilateral central neck dissection.

The resected specimen was fixed by formaldehyde, stained with hematoxylin and eosin and
examined with light microscopy.

If the SLN was found to be free of malignant deposits, it was further examined by
immunohistochemical staining.

Statistical analysis: Descriptive statistics were used to analyze demographic data.
Sensitivity, specificity and predictive value of the SLN were calculated.

The histopathological report of the excised specimen was considered the criterion standard.

Inclusion Criteria:

- Patient diagnosed to have differentiated thyroid carcinoma and has no detectable
cervical lymphadenopathy.

Exclusion Criteria:

- Previous neck surgery, pregnancy and known hypersensitivity to the dye used.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The lymph nodes around the thyroid tumour will be removed and examined under microscopy in all study subjects to verify that the stained node is a true representative to the state of lymph nodes as regards tumour spread

Outcome Time Frame:

the lymph nodes removed during the surgery will be examined the next day of the operation

Safety Issue:


Principal Investigator

Yasser M Hamza, A Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Faculty of Medicine, University of Alexandria


Egypt: Ministry of Health and Population

Study ID:




Start Date:

December 2002

Completion Date:

April 2009

Related Keywords:

  • Thyroid Cancer
  • Lymph Node Metastasis
  • Sentinel lymph node
  • thyroid cancer
  • neck dissection
  • Thyroid Neoplasms
  • Neoplasm Metastasis
  • Thyroid Diseases