Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

NCT05746780 | Completed

• 1 other identifier: 3364
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Cancer; Larynx; Larynx Cancer; Neck

Keywords

neck dissection; SALVAGE TOTAL LARYNGECTOMY

Outcome Measures

Primary Outcomes (1)

• Occult lymph node metastasis

  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

  At the time of salvage surgery

Secondary Outcomes (3)

• Complications of bilateral neck dissection during hospitalization

  Up to 15 days from salvage surgery

• Overall survival

  5 year

• Disease specific survival

  5 years

Interventions

Elective bilateral neck dissection in cN0 patients PROCEDURE

Radical modified type 3 selective bilaterale elective neck dissection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient affected by recurrent laryngeal cancer, after failure of primary radiotherapy or conservative surgery, with clinically negative neck (cN0) and treated with salvage total laryngectomy and concomitant elective selective bilateral neck dissection (levels II-IV + VI).

You may qualify if:

• patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cN0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels II, III, IV and VI).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Stefano Settimi

Roma, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Laryngeal Diseases; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Respiratory Tract Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of dept. of Otorinolaringology

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 28, 2023
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)