Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Completed
• CT.gov ID: NCT05746780
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 13.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Cancer; Larynx; Larynx Cancer; Neck	Procedure: Elective bilateral neck dissection in cN0 patients

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Clinical Value and Prognostic Impact of Bilateral Elective Neck Dissection in Salvage Total Laryngectomy of cN0 Cases
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Outcome Measures

Primary Outcome Measures

1. 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

1. Complications of bilateral neck dissection during hospitalization [Up to 15 days from salvage surgery]

   Complications of bilateral neck dissection during hospitalization

2. Overall survival [5 year]

   Survival of the patient from any disease

3. Disease specific survival [5 years]

   Survival of the patient from laryngeal disease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stefano Settimi	Roma		Italy

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galli Jacopo, Professor, head of dept. of Otorinolaringology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05746780
• Other Study ID Numbers: 3364
• First Posted: Feb 28, 2023
• Last Update Posted: Feb 28, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Galli Jacopo, Professor, head of dept. of Otorinolaringology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS: neck dissection; SALVAGE TOTAL LARYNGECTOMY
• Additional relevant MeSH terms: Laryngeal Neoplasms; Laryngeal Diseases

Study Results

No Results Posted as of Feb 28, 2023