Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06149637

Lateral Cervical Node Dissection in Differentiated Thyroid Cancer.

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)

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Alma Mater de Antioquia

Medellín, Antioquia, 050010, Colombia

Location status: Recruiting

Location contact

Alvaro Sanabria, MD

CONTACT

[email protected]

573138175170

Carlos Betancour, MD

SUB_INVESTIGATOR

Carlos Garcia, MD

SUB_INVESTIGATOR

Juan G Sanchez, MD

SUB_INVESTIGATOR

Yessica Trujillo, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years.
  • Patients with macroscopic lymph node involvement identified by physical examination, imaging or intraoperatively in lateral neck.
  • Patients with microscopic nodal involvement confirmed by FNAB (definition by the pathologist of suspected or confirmed metastatic papillary carcinoma according to the Bethesda criteria)
  • Candidates for lateral lymph node dissection due to suspected or confirmed disease metastatic lymph nodes as defined by the treating surgeon.
  • Patients requiring or not requiring thyroidectomy and/or central dissection concomitant with the dissection

Exclusion criteria

  • Patients with a history of previous neck dissection
  • Histological confirmation of medullary or anaplastic carcinoma
  • Previous spinal nerve injury

Treatment and study plan

Traditional neck dissection approach

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

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

Primary outcomes

  1. Shoulder dysfunction

    Time frame: 2 weeks, 3 months, 6 months, and 1 year

    (SPADI shoulder pain and disability questionnaire, validated in Spanish) Minimun score 0, maximun 100, a higher score means higher disability

  2. Cervical disconfort

    Time frame: 2 weeks, 3 months, 6 months, and 1 year

    The Cervical Disability Index (IDC) validated in Spanish Minimun score 0, maximun 50, a higher score means higher disability

  3. Complications

    Time frame: 30 days

    Temporary or permanent accessory nerve injury measured in the physical examination by limitation of the lateral range of movement of the shoulder less than 50%

    • Bleeding defined by the treating surgeon by physical examination
    • Wound infection: infection in the first 30 days after surgery, diagnosed with at least one of the following criteria: presence of purulent discharge from the surgical wound, presence of microorganisms isolated by taking a culture of wound discharge , presence of at least one of the signs and symptoms of inflammation (pain, redness, edema, heat).
    • Chylous fistula defined as milky discharge from the cervical drain with a triglyceride count higher than the serum.
    • Mortality
    • Re Operation before 30 days

Secondary outcomes

  1. Total lymph node count.

    Time frame: 30 days

    Total number of resected and compromised lymph nodes according to the histopathology report

  2. Surgical time

    Time frame: 30 days

    Surgical time in minutes according to the surgical report

  3. Lateral lymph node recurrence

    Time frame: 5 years

    Number of participants with presence of tumor in the neck lymph nodes detected during follow-up by physical examination or imaging 6 months or more after primary surgery and confirmed cytopathologically.

  4. Dynamic response

    Time frame: 5 years

    Number of participants with excellent, incomplete biochemical, incomplete structural or undetermined response according to the ATA classification.

  5. Overall and disease-free survival

    Time frame: 5 years

    Overall and disease-free survival measured from the day of surgery until recurrence or termination of follow-up.

  6. Length of postoperative hospital stay.

    Time frame: 30 days

    Length of postoperative hospital stay.

Study contacts

Contact information is provided by the study sponsor or research team.

Alvaro Sanabria, MD

CONTACT

[email protected]

3138175170

Sponsors and collaborators

Lead sponsor

Centro de Excelencia en Enfermedades de Cabeza y Cuello

Other

Collaborators

  • Clinica Las Vegas- Grupo QuironSalud
  • Hospital Alma Mater de Antioquia
  • Hospital San Vicente Fundación

Registry information

Official study title

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 dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Nov 29, 2023
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.