Fascial Versus Standard Neck Dissection in Patients With N1b Papillary Thyroid Carcinoma

NCT ID: NCT05804682

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 195 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-01-31

Brief Summary

Optimal surgical technique for neck dissection (LND) in thyroid carcinoma remains a subject of debate. Fascial ND (FND) implies the removal of the superficial and middle layers of the deep cervical fascia en bloc with lymph-nodes containing fibro-fatty tissue (levels IIa-Vb and VI-VII for cN1b patients). This retrospective cohort study was designed to compare FND with standard, non-fascial, selective ND (SND).

Detailed Description

In thyroid cancer patients, lymph node dissection includes a comprehensive removal of all the target nodal basins: anterior cervical compartment (level VI) and the superior mediastinal nodes that can be reached via cervical incision (level VII) in CND, and levels IIa-Vb in LND. Clearance of those levels without including the enveloping fasciae in the specimen is referred to hereafter as Standard Neck Dissection (SND), as it is the most common technique applied for thyroid tumors. In Fascial Neck Dissection, the comprehensive clearance of the target basins is achieved by following the planes of coalescence of the cervical fascial layers. Those are avascular and enable the removal of the target nodes en bloc with their investing fascial layers.

The aim of this retrospective study was to compare the outcomes between fascial and standard approach in N1b PTC patients that underwent surgery for N1b papillary thyroid cancer. The primary objective was to achieve a significantly higher nodal yield by applying the fascial neck dissection technique and reduce rates of early loco-regional recurrence. Secondary objectives were the evaluation of short and long-term post-operative complications and the cosmetic result.

Conditions

Patients With Papillary Thyroid Cancer and N1b Status

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients that underwent fascial dissection for N1b papillary thyroid cancer

Fascial Neck Dissection

Intervention Type: PROCEDURE

Central and lateral neck dissection with the fascial technique

Patients that underwent ftandard dissection for N1b papillary thyroid cancer

Standard Neck Dissection

Intervention Type: PROCEDURE

Central and lateral neck dissection with the standard technique

Interventions

Fascial Neck Dissection

Central and lateral neck dissection with the fascial technique

Intervention Type: PROCEDURE

Standard Neck Dissection

Central and lateral neck dissection with the standard technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Patients who met all the following criteria were eligible for inclusion in this retrospective evaluation:

• Male or female patients, living or deceased, aged 18 years or older at the time of operation
• Unilateral (left/right) or bilateral lateral neck dissection along with central neck dissection
• Patients with papillary cancer, pN1b. This excludes patients with other types of thyroid cancer (e.g., medullary, follicular, and anaplastic);
• Patients that underwent central and/or lateral neck dissection as a primary intervention. This excludes patients with any previous operation for thyroid disease involving any type of lymph node dissection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Countries

Italy

Other Identifiers

4818

Identifier Type: -

Identifier Source: org_study_id