Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer
Condition: Low-risk Papillary Thyroid Cancer; Endocrine Malignancy; Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases
Intervention: Total Thyroidectomy (TT); Prophylactic central neck lymph node dissection (pCND)
Intervention description: Total removal of thyroid; Lymph node dissection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Thyroidectomy; Serum Thyroglobulin; Quality of Life; Central Neck Lymph Node Metastasis; Central Neck Lymph Node Dissection

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 and/or radioactive iodine.

        -  Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a
           capsule or liquid and lie under a camera.

        -  6 months: ultrasound and maybe laryngoscopy.

        -  1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone.

        -  Participants will have annual follow-up visits for 10 years. They will have a physical
           exam, blood drawn, scans, and may complete a questionnaire.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Patients must have histologically or cytologically confirmed at least 1 thyroid nodule
             that is greater than or equal to1 cm. but less than or equal to 4 cm measured in
             greatest dimension and confirmed by the Laboratory of Pathology, National Cancer
             Institute (NCI) or confirmed by the pathology laboratory of the enrolling institution:

               -  Indeterminate thyroid biopsy per Bethesda System for reporting thyroid
                  cytopathology with B-Raf Proto-oncogene Serine/Threonine Kinase (BRAF) Valine 600
                  Glutamic Acid (V600E) mutation or rearranged in transformation/papillary thyroid
                  carcinomas (RET/PTC) rearrangement

               -  Cytologically or histologically suspicious or confirmed PTC per Bethesda System
                  for reporting thyroid cytopathology.

          -  Age greater than or equal to 18 years. Because PTC occurs rarely in patients <18 years
             of age, children are excluded from this study.

          -  Absence of radiographic evidence of extrathyroidal extension.

          -  Absence of abnormal lymphadenopathy suggesting metastatic PTC on physical examination
             and/or imaging studies.

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

          -  Patients must have adequate organ function to safely undergo general anesthesia and
             thyroidectomy. Laboratory values obtained less than or equal to 4 weeks prior to
             surgery must demonstrate adequate bone marrow function (hemoglobin (Hb) greater than
             or equal to 6.0 mmol/L, absolute neutrophil count greater than or equal to 1.5 x
             10^9/L, platelets greater than or equal to 80 x 10^9/L), liver function (serum
             bilirubin less than or equal to 2 x upper limit of normal (ULN), serum transaminases
             less than or equal to 3 x ULN). Patients with chronic kidney disease who are on
             chronic renal replacement therapy are allowed. Other tests, such as pulmonary function
             tests, cardiac echocardiogram or stress test, will be performed if clinically
             indicated.

          -  Ability of subject to understand and the willingness to sign a written informed
             consent document.

          -  Women must not become pregnant prior to surgery or during the first 3 months after
             surgery. Women who can become pregnant will be asked to practice an effective form of
             birth control for up to 3 months after surgery.

        EXCLUSION CRITERIA:

          -  Patients who have had previous thyroid surgery

          -  Patients whose tumors are deemed unresectable by clinical/imaging criteria.

          -  Patients with known synchronous distant metastatic disease.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Pregnant women are excluded because we do not want to expose the unborn child to the
             procedures necessary to perform the surgery.