Lateral Cervical Node Dissection in Differentiated Thyroid Cancer.

NCT06149637 | Recruiting

• 1 other identifier: IN53-2021
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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)

Conditions

Thyroid Cancer

Keywords

neck dissection; shoulder disfunction; randomized clinical trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Total lymph node count.

  30 days

• Surgical time

  30 days

• Lateral lymph node recurrence

  5 years

• Dynamic response

  5 years

• Overall and disease-free survival

  5 years

Study Arms (2)

Traditional neck dissection approach

ACTIVE COMPARATOR

Traditional neck dissection approach

Procedure: Traditional neck dissection approach

Anterior neck dissection approach

EXPERIMENTAL

Anterior neck dissection

Procedure: Anterior neck dissection approach

Interventions

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.

Traditional neck dissection approach

Anterior 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 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.

Anterior neck dissection approach

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centro de Excelencia en Enfermedades de Cabeza y Cuello: lead
• Hospital Alma Mater de Antioquia: collaborator
• Hospital San Vicente Fundación: collaborator
• Clinica Las Vegas- Grupo QuironSalud: collaborator

Study Sites (1)

Hospital Alma Mater de Antioquia

Medellín, Antioquia, 050010, Colombia

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Alvaro Sanabria

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro Sanabria, MD

CONTACT

3138175170; alvarosanabria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Researcher

Model Details: Randomized, parallel, multicenter stratified clinical trial with 1:1 allocation.

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: November 29, 2023
• Study Start: August 1, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)