Comparing neck dissection techniques for thyroid cancer treatment
Comparison of Two Routes of Surgical Approach to Lateral Cervical Node Dissection in Differentiated Thyroid Cancer Patients With Lateral Metastatic Disease: Randomized Clinical Trial
NA · Centro de Excelencia en Enfermedades de Cabeza y Cuello · NCT06149637
This study is testing two different surgical methods for removing lymph nodes in patients with thyroid cancer to see which one causes fewer problems afterward.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Centro de Excelencia en Enfermedades de Cabeza y Cuello (other) |
| Locations | 1 site (Medellín, Antioquia) |
| Trial ID | NCT06149637 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the shoulder and neck morbidity associated with two different surgical approaches for cervical lateral nodal dissection in patients with differentiated thyroid cancer and lateral metastases. Specifically, it compares the traditional neck dissection approach with an anterior approach to the sternocleidomastoid muscle. The study will involve patients who have confirmed lymph node involvement and will assess the effectiveness and complications of each surgical method. By analyzing outcomes, the research seeks to determine the optimal surgical technique for minimizing morbidity while effectively treating thyroid cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed lateral lymph node involvement due to differentiated thyroid cancer.
Not a fit: Patients with a history of previous neck dissection or those diagnosed with medullary or anaplastic carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that reduce complications for patients undergoing treatment for thyroid cancer.
How similar studies have performed: While there have been studies on neck dissection techniques, this specific comparison of anterior versus traditional approaches in the context of differentiated thyroid cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥ 18 years. 2. Patients with macroscopic lymph node involvement identified by physical examination, imaging or intraoperatively in lateral neck. 3. Patients with microscopic nodal involvement confirmed by FNAB (definition by the pathologist of suspected or confirmed metastatic papillary carcinoma according to the Bethesda criteria) 4. Candidates for lateral lymph node dissection due to suspected or confirmed disease metastatic lymph nodes as defined by the treating surgeon. 5. Patients requiring or not requiring thyroidectomy and/or central dissection concomitant with the dissection Exclusion Criteria: 1. Patients with a history of previous neck dissection 2. Histological confirmation of medullary or anaplastic carcinoma 3. Previous spinal nerve injury
Where this trial is running
Medellín, Antioquia
- Hospital Alma Mater de Antioquia — Medellín, Antioquia, Colombia (RECRUITING)
Study contacts
- Principal investigator: Alvaro Sanabria — Universidad de Antioquia
- Study coordinator: Alvaro Sanabria, MD
- Email: alvarosanabria@gmail.com
- Phone: 3138175170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Cancer, neck dissection, shoulder disfunction, randomized clinical trial