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

NCT05804682 | Completed

• 1 other identifier: 4818
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

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).

Conditions

Patients With Papillary Thyroid Cancer and N1b Status

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Patients that underwent fascial dissection for N1b papillary thyroid cancer

Procedure: Fascial Neck Dissection

Patients that underwent ftandard dissection for N1b papillary thyroid cancer

Procedure: Standard Neck Dissection

Interventions

Fascial Neck Dissection PROCEDURE

Central and lateral neck dissection with the fascial technique

Patients that underwent fascial dissection for N1b papillary thyroid cancer

Standard Neck Dissection PROCEDURE

Central and lateral neck dissection with the standard technique

Patients that underwent ftandard dissection for N1b papillary thyroid cancer

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2023
• Last Updated: April 7, 2023

Record last verified: 2022-03

Locations

IT (1)