The mainstay of therapy for papillary thyroid cancer (PTC) is surgical excision, consisting of total thyroidectomy. Lymph node recurrence following thyroidectomy is a substantial clinical problem. In an attempt to decrease recurrence, prophylactic central neck dissection is often performed along with total thyroidectomy. Based only on expert opinion, current American Thyroid Association (ATA) practice guidelines recommend prophylactic central neck dissection. However, addition of a prophylactic central neck dissection may not be necessary for the majority of patients and may substantially increase postsurgical morbidities of hypocalcemia and deficits in swallowing, communicative function and health-related quality of life (HR-QOL). The probability and extent of these morbidities are currently unknown. Before routine central neck dissection can be adopted as a standard treatment it is important that the true risks and benefits of this procedure are systematically examined. The fact that only expert opinion guides this recommendation argues for the need for a prospective clinical trial to fully evaluate this common and potentially morbid clinical problem. Our hypothesis is that total thyroidectomy with prophylactic central neck dissection results in an increased rate of complications in comparison with total thyroidectomy alone for PTC without an associated benefit to the patient. We will test this hypothesis with a randomized clinical trial in which 140 patients undergoing total thyroidectomy for PTC with no preoperative evidence of distant or cervical lymph node metastasis will be randomized into one of two groups: prophylactic central neck dissection or no central neck dissection. This work has four specific aims in which patients with PTC undergoing total thyroidectomy with central neck dissection will be contrasted with those undergoing total thyroidectomy alone: (1) To determine the rate of transient and persistent hypocalcemia;(2) To determine the rate of voice and swallowing problems;(3) To determine the degree to which HR-QOL is compromised;and, (4) To determine clinical recurrence rates. The results of the proposed research will lead to an increased understanding of the manner in which prophylactic central neck dissection affects critical functions of the head and neck and cancer recurrence in patients with PTC. Due to the potentially serious and pervasive problems encountered in communicative function and swallowing in patients with PTC, it is of great importance to add to this knowledge base, to test interventions, and to lay the groundwork for evidence-based practice, particularly for untested surgical interventions in current use. Our findings have a high likelihood of yielding meaningful findings and solid evidence related to an important clinical issue.

Public Health Relevance

Thyroid cancer is usually treated with the complete surgical removal of the thyroid gland, but due to concerns that the cancer may recur in the future, lymph nodes in the central part of the neck may also be surgically removed. Unfortunately, the additional lymph node surgery may be associated with increased risks for complications such as inadequate calcium, problems with voice function, swallowing deficits, and generally diminished quality of life. Because the risks for these complications are poorly defined, we propose to do a randomized clinical trial where we will compare clinical recurrence rates and complication levels in patients with papillary thyroid cancer who have thyroid gland removal alone to those who receive thyroid gland removal plus lymph node surgery in the central neck.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA176911-01A1
Application #
8631519
Study Section
Motor Function, Speech and Rehabilitation Study Section (MFSR)
Program Officer
O'Mara, Ann M
Project Start
2014-01-01
Project End
2018-12-31
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
1
Fiscal Year
2014
Total Cost
$378,091
Indirect Cost
$93,777
Name
University of Wisconsin Madison
Department
Surgery
Type
Schools of Medicine
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715