Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05746780

Enrollment

Registered

2023-02-28

Start date

2020-09-01

Completion date

2021-03-01

Last updated

2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Larynx, Larynx Cancer, Neck, Neck Cancer

Keywords

neck dissection, SALVAGE TOTAL LARYNGECTOMY

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.

Interventions

PROCEDUREElective bilateral neck dissection in cN0 patients

Radical modified type 3 selective bilaterale elective neck dissection

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026