Trial Title:
Lateral Cervical Node Dissection in Differentiated Thyroid Cancer.
NCT ID:
NCT06149637
Condition:
Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
neck dissection
shoulder disfunction
randomized clinical trial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, parallel, multicenter stratified clinical trial with 1:1 allocation.
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Traditional neck dissection approach
Description:
.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.
Arm group label:
Traditional neck dissection approach
Intervention type:
Procedure
Intervention name:
Anterior neck dissection approach
Description:
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.
Arm group label:
Anterior neck dissection approach
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Alma Mater de Antioquia
Address:
City:
Medellin
Zip:
050010
Country:
Colombia
Status:
Recruiting
Contact:
Last name:
Alvaro Sanabria, MD
Phone:
573138175170
Email:
alvarosanabria@gmail.com
Investigator:
Last name:
Carlos Garcia, MD
Email:
Sub-Investigator
Investigator:
Last name:
Juan G Sanchez, MD
Email:
Sub-Investigator
Investigator:
Last name:
Carlos Betancour, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yessica Trujillo, MD
Email:
Sub-Investigator
Start date:
August 1, 2023
Completion date:
August 31, 2028
Lead sponsor:
Agency:
Centro de Excelencia en Enfermedades de Cabeza y Cuello
Agency class:
Other
Collaborator:
Agency:
Hospital Alma Mater de Antioquia
Agency class:
Other
Collaborator:
Agency:
Hospital San Vicente Fundación
Agency class:
Other
Collaborator:
Agency:
Clinica Las Vegas- Grupo QuironSalud
Agency class:
Other
Source:
Centro de Excelencia en Enfermedades de Cabeza y Cuello
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149637
