Thyroid CancerNCT06149637
Lateral Cervical Node Dissection in Differentiated Thyroid Cancer.
A study testing Traditional neck dissection approach and Anterior neck dissection approach in people with Thyroid Cancer, run by Centro de Excelencia en Enfermedades de Cabeza y Cuello at 1 site in Colombia.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Traditional neck dissection approach and Anterior neck dissection approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteColombia
- Study dates
- 1 Aug 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with a history of previous neck dissection
- Histological confirmation of medullary or anaplastic carcinoma
- Previous spinal nerve injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Alma Mater de Antioquia
Medellín, Antioquia, 050010
Alvaro Sanabria, MD, 573138175170, alvarosanabria@gmail.com
Carlos Garcia, MD
About this study
Official 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
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)
Read the 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
- Being tested
- Traditional neck dissection approach, Anterior neck dissection approach
- Keywords
- neck dissection, shoulder disfunction, randomized clinical trial
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional neck dissection approachProcedure or surgery
.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 approachProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional neck dissection approach | Active comparator | Traditional neck dissection approach Receives: Procedure: Traditional neck dissection approach |
| Anterior neck dissection approach | Experimental | Anterior neck dissection Receives: Procedure: Anterior neck dissection approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder dysfunction
(SPADI shoulder pain and disability questionnaire, validated in Spanish) Minimun score 0, maximun 100, a higher score means higher disability
Measured: 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
Measured: 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
Measured: 30 days
Secondary outcomes (6)
Total lymph node count.
Total number of resected and compromised lymph nodes according to the histopathology report
Measured: 30 days
Surgical time
Surgical time in minutes according to the surgical report
Measured: 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.
Measured: 5 years
Dynamic response
Number of participants with excellent, incomplete biochemical, incomplete structural or undetermined response according to the ATA classification.
Measured: 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.
Measured: 5 years
Length of postoperative hospital stay.
Length of postoperative hospital stay.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Aug 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, multicenter stratified clinical trial with 1:1 allocation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Excelencia en Enfermedades de Cabeza y Cuello
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Alma Mater de Antioquia, Hospital San Vicente Fundación, Clinica Las Vegas- Grupo QuironSalud
- Responsible party
- Principal investigator, Alvaro Sanabria, Centro de Excelencia en Enfermedades de Cabeza y Cuello
- Investigators
- Alvaro Sanabria, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149637
- Sponsor's protocol ID
- IN53-2021
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06149637
- Acronym / sponsor ID
- IN53-2021
- Conditions
- Thyroid Cancer
- Keywords
- neck dissection, shoulder disfunction, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Centro de Excelencia en Enfermedades de Cabeza y CuelloUniversity, hospital or other
- Collaborators
- Hospital Alma Mater de Antioquia, Hospital San Vicente Fundación, Clinica Las Vegas- Grupo QuironSalud
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, parallel, multicenter stratified clinical trial with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Traditional neck dissection approach | Active comparator | Procedure: Traditional neck dissection approachTraditional neck dissection approach |
| Anterior neck dissection approach | Experimental | Procedure: Anterior neck dissection approachAnterior neck dissection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with a history of previous neck dissection
- Histological confirmation of medullary or anaplastic carcinoma
- Previous spinal nerve injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Traditional neck dissection approach |
| Anterior neck dissection approach1. 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. | Procedure or surgery | Anterior neck dissection approach |
Primary outcome
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
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
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
6 secondary outcomes
Total lymph node count.
Time frame: 30 days
Surgical time
Time frame: 30 days
Lateral lymph node recurrence
Time frame: 5 years
Dynamic response
Time frame: 5 years
Overall and disease-free survival
Time frame: 5 years
Length of postoperative hospital stay.
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alvaro Sanabria principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional neck dissection approach and Anterior neck dissection approach in people with Thyroid Cancer, run by Centro de Excelencia en Enfermedades de Cabeza y Cuello at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Sanabria, MD (3138175170, alvarosanabria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder dysfunction (time frame: 2 weeks, 3 months, 6 months, and 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.