Clinical Trial: Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Controlled Trial of Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in Patients With Low-risk Papillary Thyroid Cancer

Brief Summary:

Background:

- Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard to detect. People often have lymph nodes removed anyway, and researchers want to study if this is a good idea.

Objective:

- To compare the effectiveness of removing lymph nodes in the neck that show no evidence of cancer along with the thyroid, or removing only the thyroid.

Eligibility:

- Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence that the disease has spread in the body.

Design:

  • Participants will be screened with medical history, physical exam, blood tests, scans, and x-rays.
  • Participants will:
  • Answer questions. They may have a tumor biopsy.
  • Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal cords.
  • Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be removed if the cancer has spread.
  • Group 2: have surgery to remove the thyroid and lymph nodes in the neck.
  • At all post-surgery visits, participants will answer questions and have blood drawn. In addition:
  • 1 day: laryngoscopy.
  • 2 weeks: possible laryngoscopy.
  • 3 months: ultrasound of the thyroid and neck.
  • Discuss whether to try hormone treatment a

    Detailed Summary:

    Background:

    • Thyroid cancer is the most common endocrine malignancy and papillary thyroid cancer (PTC) accounts for more than 80% of thyroid cancer.
    • The incidence of thyroid cancer has risen over the past decades.
    • Central neck lymph node metastasis (LNM) is common in PTC and preoperative imaging studies do not identify all involved lymph nodes in the central neck.
    • It remains controversial if prophylactic central neck lymph node dissection (pCND) in patients with low-risk PTC results in lower rates of persistent/recurrent disease and higher complication rates as there has been no randomized controlled trial addressing these issues to date.
    • Serum thyroglobulin (Tg), especially when TSH-stimulated, is a very sensitive and specific marker for persistent/recurrent PTC, in the absence of interfering anti-Tg antibodies.
    • Retrospective studies have compared the postoperative TSH-stimulated Tg levels between those who underwent pCND and those who did not with conflicting results. A randomized trial is needed.
    • Health-related quality of life (QOL) is a well-accepted tool to measure the outcome of cancer treatments. SF-36 v2 questionnaire has been frequently used to evaluate the QOL in patients with thyroid cancer. There is no study evaluating the difference in QOL in patients with low-risk PTC undergoing total thyroidectomy (TT) with and without pCND.

    Objectives:

    -To determine and compare biochemical cure rates in patients with low-risk PTCs undergoing total thyroidectomy (TT) with and without pCND as measured by postoperative TSH-stimulated
    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome: Biochemical cure rates in patients with low-risk PTCs [ Time Frame: 3 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: April 3, 2015
    Date Started: March 25, 2015
    Date Completion: April 7, 2025
    Last Updated: April 26, 2017
    Last Verified: April 20, 2017