Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

Completed

• Conditions: Larynx; Neck Cancer; Neck; Larynx Cancer

• Registration Number: NCT05746780
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary objective will be the assessment of complication rate and the evaluation of 5-year Overall Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

• patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occult lymph node metastasis	At the time of salvage surgery	Incidence rate of occult lymph node metastasislaryngectomy with clinically negative lymph nodes (cN0), estimating the prevalence of histologically positive lymph nodes (pN+) and predictive factors for cervical lymph nodes metastasis

Secondary Outcome Measures

Name	Time	Method
Complications of bilateral neck dissection during hospitalization	Up to 15 days from salvage surgery	Complications of bilateral neck dissection during hospitalization
Overall survival	5 year	Survival of the patient from any disease
Disease specific survival	5 years	Survival of the patient from laryngeal disease

Trial Locations

Locations (1)

Stefano Settimi; 🇮🇹 Roma, Italy