Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

Larynx Cancer Clinical Trial

Official title:

Clinical Value and Prognostic Impact of Bilateral Elective Neck Dissection in Salvage Total Laryngectomy of cN0 Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05746780
• Other study ID #: 3364
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion criteria -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).

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.

Related Conditions & MeSH terms

• Laryngeal Diseases
• Laryngeal Neoplasms
• Larynx
• Larynx Cancer
• Neck
• Neck Cancer

Intervention

Procedure:
• Elective bilateral neck dissection in cN0 patients
Radical modified type 3 selective bilaterale elective neck dissection

Locations

Country	Name	City	State
Italy	Stefano Settimi	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications of bilateral neck dissection during hospitalization	Complications of bilateral neck dissection during hospitalization	Up to 15 days from salvage surgery
Secondary	Overall survival	Survival of the patient from any disease	5 year
Secondary	Disease specific survival	Survival of the patient from laryngeal disease	5 years