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

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)

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Procedure: Traditional neck dissection approach; Procedure: Anterior neck dissection approach

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alvaro Sanabria, MD; Phone Number: 3138175170; Email: alvarosanabria@gmail.com

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050010
      • Recruiting
      • Hospital Alma Mater de Antioquia
      • Contact: Alvaro Sanabria, MD; Phone Number: 573138175170; Email: alvarosanabria@gmail.com
      • Sub-Investigator: Carlos Garcia, MD
      • Sub-Investigator: Juan G Sanchez, MD
      • Sub-Investigator: Carlos Betancour, MD
      • Sub-Investigator: Yessica Trujillo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional neck dissection approach	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.
Experimental: Anterior neck dissection approach; Anterior neck dissection	Procedure: Anterior neck dissection approach; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder dysfunction	(SPADI shoulder pain and disability questionnaire, validated in Spanish) Minimun score 0, maximun 100, a higher score means higher disability	2 weeks, 3 months, 6 months, and 1 year
Cervical disconfort	The Cervical Disability Index (IDC) validated in Spanish Minimun score 0, maximun 50, a higher score means higher disability	2 weeks, 3 months, 6 months, and 1 year
Complications	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total lymph node count.	Total number of resected and compromised lymph nodes according to the histopathology report	30 days
Surgical time	Surgical time in minutes according to the surgical report	30 days
Lateral lymph node recurrence	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.	5 years
Dynamic response	Number of participants with excellent, incomplete biochemical, incomplete structural or undetermined response according to the ATA classification.	5 years
Overall and disease-free survival	Overall and disease-free survival measured from the day of surgery until recurrence or termination of follow-up.	5 years
Length of postoperative hospital stay.	Length of postoperative hospital stay.	30 days

Collaborators and Investigators

• Sponsor: Centro de Excelencia en Enfermedades de Cabeza y Cuello
• Collaborators: Hospital San Vicente Fundación; Hospital Alma Mater de Antioquia; Clinica Las Vegas- Grupo QuironSalud
• Investigators: Principal Investigator: Alvaro Sanabria, Universidad de Antioquia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: randomized clinical trial; neck dissection; shoulder disfunction
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: IN53-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No