Active Surveillance Program in Thyroid Nodules

Summary

Overview This study focuses on thyroid nodules, specifically the Bethesda IV-VI categories, which have uncertain or suspicious malignancy. The idea is to observe and monitor these nodules instead of opting for immediate surgery, a practice known as active surveillance. The main goal of active surveillance is to avoid unnecessary surgeries, which can lead to complications like nerve damage or hypoparathyroidism.

Problem and Objectives Thyroid nodules in these Bethesda categories can be cancerous, but not all require immediate removal. Active surveillance tracks nodule growth and other changes using regular ultrasounds and clinical checkups. This approach is gaining popularity, especially in Japan, Europe, and the U.S., but there's still a need for more data, particularly in Latin America.

The primary objectives of the study are:

General: To describe the clinical and imaging characteristics of patients with Bethesda IV-VI nodules under active surveillance.

Specific: To measure surgery rates, reasons for surgery, and how long patients can avoid surgery.

Methodology This study is a multicenter historical cohort study, which will look at patients treated from 2019 to 2023 in different hospitals. Patients included in the study are those with Bethesda IV-VI thyroid nodules, who are over 18 and have been managed without immediate thyroid surgery. Data will be collected from medical records and imaging reports, and patients will be followed up to document any changes in their nodules, including growth or metastasis.

Expected Impact The study aims to determine whether active surveillance can safely delay or avoid surgery for selected patients. It could have a significant impact on clinical decision-making, improving patient outcomes and reducing unnecessary surgeries, especially within the Colombian healthcare system. If successful, this approach could reduce costs and improve the quality of life for patients with thyroid nodules.

Ethical Considerations The study will follow ethical guidelines, ensuring patient confidentiality and classifying the research as "no-risk," meaning it involves minimal risk to the participants.

Conditions

• Thyroid Nodule

Interventions

OTHER

Active surveillance

a non-operative management strategy aimed at avoiding unnecessary surgery in patients with thyroid nodules with a cytopathological diagnosis of Bethesda IV-VI, who do not present clinical or imaging characteristics suggesting malignancy and/or aggressiveness.

Sponsors & Collaborators

• Hospital Alma Mater de Antioquia

  collaborator UNKNOWN

• Hospital San Vicente Fundación

  collaborator OTHER

• Clinica Somer

  collaborator UNKNOWN

• Centro de Excelencia en Enfermedades de Cabeza y Cuello

  lead OTHER

Principal Investigators

• Alvaro Sanabria · Universidad de Antioquia

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2026-02-01

Completion

2026-07-01

Countries

• Colombia

Study Locations