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Completed

NCT Number: NCT05804682

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fascial Neck Dissection

Procedure

Central and lateral neck dissection with the fascial technique

standard neck dissection

Procedure

Central and lateral neck dissection with the standard technique

Primary outcomes

  1. Early loco-regional recurrence

    Time frame: Interventions 2018-2021, Final follow up January 2023

    Locoregional recurrence within 1 year from operation

  2. Harvested lymph nodes

    Time frame: Interventions 2018-2021, Final follow up January 2023

    Total and positive lymph node yields for central and lateral compartments

Secondary outcomes

  1. Early and late complications

    Time frame: Interventions 2018-2021, Final follow up January 2023

  2. Voice and swallowing score comparisons

    Time frame: Interventions 2018-2021, Final follow up January 2023

  3. Cosmetic outcome

    Time frame: Interventions 2018-2021, Final follow up January 2023

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: FADO

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.