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

Fascial Versus Standard Neck Dissection in Patients With N1b Papillary Thyroid Carcinoma: a 4-year Analysis of Outcomes.

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).

Study Overview

• Status: Completed
• Conditions: Patients With Papillary Thyroid Cancer and N1b Status
• Intervention / Treatment: Procedure: Fascial Neck Dissection; Procedure: Standard Neck Dissection

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.

• Study Type: Observational
• Enrollment (Actual): 195

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that were operated for N1b papillary thyroid cancer in the Division of Endocrine and Metabolic Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy between 2018 and 2021. All patients eligible for inclusion were screened for eligibility in a systematic fashion both from the records of our center in the Eurocrine registry and from our center's internal prospective de-identified database concerning thyroid cancer.

Description

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.

Exclusion criteria: patient's age < 18 years, patients that underwent previous neck dissection of any type and patients who refused or were unable to provide adequate follow up data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients that underwent fascial dissection for N1b papillary thyroid cancer	Procedure: Fascial Neck Dissection; Central and lateral neck dissection with the fascial technique
Patients that underwent ftandard dissection for N1b papillary thyroid cancer	Procedure: Standard Neck Dissection; Central and lateral neck dissection with the standard technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early loco-regional recurrence	Locoregional recurrence within 1 year from operation	Interventions 2018-2021, Final follow up January 2023
Harvested lymph nodes	Total and positive lymph node yields for central and lateral compartments	Interventions 2018-2021, Final follow up January 2023

Secondary Outcome Measures

Outcome Measure	Time Frame
Early and late complications	Interventions 2018-2021, Final follow up January 2023
Voice and swallowing score comparisons	Interventions 2018-2021, Final follow up January 2023
Cosmetic outcome	Interventions 2018-2021, Final follow up January 2023

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Thyroid Diseases; Thyroid Neoplasms; Thyroid Cancer, Papillary
• Other Study ID Numbers: 4818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only after individual contact by researchers of the field

Drug and device information, study documents

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