Lateral Cervical Node Dissection in Differentiated Thyroid Cancer.

NCT ID: NCT06149637

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2028-08-31

Brief Summary

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)

Detailed Description

The incidence of thyroid cancer has increased in recent decades, being responsible for 586,000 cases worldwide, ranking ninth in incidence in 2020. The rapid increase of thyroid cancer, particularly papillary thyroid cancer, has been largely attributed to the increasing use of ultrasound, along with increased use of other imaging modalities.

Similarly, analyzing the pattern of lymph node dissemination of well-differentiated thyroid carcinoma, Eskander et al., 2 reviewed all the pertinent literature up to 2011 (a total of 1,145 patients and 1,298 neck dissections) and reported an overall metastasis rate in patients taken to to surgery of 53.1%, 15.5%, 70.5%, 66.3%, 7.9% and 21.5% in levels IIa, IIb, III, IV, Va and Vb, respectively. For the Thus, the primary surgical treatment for lateral neck disease generally includes lateral neck dissection in conjunction with total thyroidectomy. Lymph node dissection should be performed in patients with biopsy-proven metastatic lateral cervical nodes. Jugular nodes located at levels II, III, and IV are the lateral neck compartments most commonly affected by CBDT and should be included in all therapeutic lateral neck dissections. Level V, which represents the posterior triangle of the neck, is affected less frequently. However, the Vb level must be dissected along with the other levels, and careful visualization and dissection of the spinal accessory nerve is paramount. Level V can be approached by an anterior approach by retracting the sternocleidomastoid muscle posteriorly, or by dissecting the posterior triangle behind the muscle sternocleidomastoid to the trapezius muscle. The precise extent of the neck dissection is a decision made based on the volume and location of the disease. The ATA recommends complete lymph node dissection (CLND), including levels II and V, for most patients with clinically evident lateral neck metastatic disease, although nuances regarding the extent of level V dissection are not clarified, in relation to whether level V should be included. Regarding the difference between the surgical techniques, the posterior approach to the sternocleidomastoid muscle involves a longer incision, where the dissection proceeds from the anterior edge of the trapezius muscle in a medial direction that includes the lymphatic contents of the supraclavicular fossa. The upper margin of this area presents the greatest risk of damage to the spinal accessory nerve. Furthermore, during the dissection of this region, several supraclavicular branches of the cervical plexus can be found. Some branches of the deep cervical plexus follow a course similar to that of the accessory nerve and may confuse the novice surgeon. In the case of the anterior approach, the incision is made up to the anterior edge of the ECM and once the accessory nerve has been identified at its insertion in the sternocleidomastoid, its course is traced superiorly to the posterior belly of the digastric. However, the effect of the anterior approach on the lymph node count and the risk of future recurrence at level V is uncertain. With these differences in terms of the approach in these two techniques, a greater length of skin incision, and greater dissection of the accessory nerve can be observed. and of the deep cervical plexus given the similar course to the XI nerve in the posterior approach, the question arises as to whether the surgical approach influences the patient's morbidity.

The main objective of the present study was to compare the morbidity and effectiveness measured in terms of lymph node count of emptying levels II to V by the anterior versus the posterior route in patients with well-differentiated thyroid cancer with lateral metastases.

Conditions

Thyroid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional neck dissection approach

Traditional neck dissection approach

Group Type: ACTIVE_COMPARATOR

Traditional neck dissection approach

Intervention Type: PROCEDURE

.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.

Anterior neck dissection approach

Anterior neck dissection

Group Type: EXPERIMENTAL

Anterior neck dissection approach

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Alma Mater de Antioquia

UNKNOWN

Sponsor Role: collaborator

Hospital San Vicente Fundación

OTHER

Sponsor Role: collaborator

Clinica Las Vegas- Grupo QuironSalud

UNKNOWN

Sponsor Role: collaborator

Centro de Excelencia en Enfermedades de Cabeza y Cuello

OTHER

Sponsor Role: lead

Responsible Party

Alvaro Sanabria

Primary Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alvaro Sanabria

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

Hospital Alma Mater de Antioquia

Medellín, Antioquia, Colombia

Site Status: RECRUITING

Countries

Colombia

Central Contacts

Alvaro Sanabria, MD

Role: CONTACT

alvarosanabria@gmail.com

3138175170

Facility Contacts

Alvaro Sanabria, MD

Role: primary

alvarosanabria@gmail.com

573138175170

Other Identifiers

IN53-2021

Identifier Type: -

Identifier Source: org_study_id