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RECRUITINGINTERVENTIONAL

Lateral Cervical Node Dissection in Differentiated Thyroid Cancer.

Comparison of Two Routes of Surgical Approach to Lateral Cervical Node Dissection in Differentiated Thyroid Cancer Patients With Lateral Metastatic Disease: Randomized Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The objective of this study is to compare shoulder and neck morbidity and the effectiveness of cervical lateral nodal dissection in patients with differentiated thyroid cancer and lateral metastases between the anterior and posterior approaches to the sternocleidomastoid muscle (SCM)

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 1. Patients with a history of previous neck dissection 2. Histological confirmation of medullary or anaplastic carcinoma 3. Previous spinal nerve injury Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Traditional neck dissection approach

.1. A transverse cervical incision is made with horizontal extension towards the affected side. 2. It is dissected through the subplatysmal plane, the posterior edge of the sternocleidomastoid muscle is dissected along its entire length. 3. Identification and dissection of the spinal nerve at Erb's point. 4. Level V nodes are dissected up to the spinal nerve without identifying or dissecting it 5. The jugular chain nodes are identified and the left level IV nodes are dissected with special attention to ligate the lymphatics of this level 6. Identification and dissection of level III nodes 7. Identification and dissection of level IIA and IIB ganglia with identification and preservation of the accessory nerve.

PROCEDURE

Anterior neck dissection approach

1. A transverse cervical incision is made with horizontal extension towards the affected side. 2. It is dissected through the subplatysmal plane, the anterior edge of the sternocleidomastoid muscle is dissected along its entire length. 3. Level V nodes are dissected up to the spinal nerve without identifying or dissecting it 4. The jugular chain nodes are identified and the left level IV nodes are dissected with special attention to ligate the lymphatics of this level 5. Identification and dissection of level III nodes 6. Identification and dissection of level IIA and IIB nodes with identification and preservation of the accessory nerve.

Locations (1)

Hospital Alma Mater de Antioquia
Medellín, Antioquia, Colombia