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Thyroid Gland Removal with or without Central Lymph Node Dissection in Treating Patients with Node Negative Thyroid Cancer

Trial Status: Active

This randomized phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. Sometimes, the lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also reduce the chance of cancer returning and the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.

Inclusion Criteria

  • Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
  • No pre-operative evidence of cervical lymph node metastases on neck ultrasound (Randomization arms ONLY)
  • No evidence of distant metastases
  • Ability to read and write in English

Exclusion Criteria

  • Largest papillary thyroid carcinoma < 1 cm in size on ultrasound
  • Previous thyroid surgery
  • Concurrent active malignancy of another type
  • Inability to give informed consent or lacks decision making capacity
  • T4 tumor
  • Pre-existing vocal cord paralysis
  • Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
  • Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
  • Becomes pregnant before surgery or at any time while on study
  • Evidence of nodal involvement identified in the operating room (OR)
  • Failure to confirm diagnosis of cancer in participant


University of Wisconsin Hospital and Clinics
Status: ACTIVE
Contact: Rebecca Sue Sippel
Phone: 608-263-1374


I. To determine the rate of transient and permanent hypocalcemia.


I. To determine the rate of voice and swallowing problems.

II. To determine the degree to which quality of life (QOL) is compromised.

III. To determine whether accurate quality of life measures can be extracted from patient interview narratives.

IV. To determine clinical recurrence rates, measures of thyroglobulin levels, and clinical evidence of recurrent disease.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients who are not receiving total thyroidectomies eligible for the randomization arms pre-operatively or are unable to be randomized intraoperatively are assigned to Arm III.

ARM I: Patients undergo total thyroidectomy alone.

ARM II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND).

ARM III: Patients undergo standard of care.

After completion of study treatment, patients are followed up at days 1 and 12, at 6 weeks, and at 6 and 12 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
University of Wisconsin Hospital and Clinics

Principal Investigator
Rebecca Sue Sippel

  • Primary ID UW13115
  • Secondary IDs NCI-2014-00833, 2014-0391
  • ID NCT02138214