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Completed

NCT Number: NCT05746780

Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

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.

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Key information

Conditions

Neck Cancer Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Larynx Larynx Cancer Neck Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stefano Settimi

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elective bilateral neck dissection in cN0 patients

Procedure

Radical modified type 3 selective bilaterale elective neck dissection

Primary outcomes

  1. Occult lymph node metastasis

    Time frame: 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 outcomes

  1. Complications of bilateral neck dissection during hospitalization

    Time frame: Up to 15 days from salvage surgery

    Complications of bilateral neck dissection during hospitalization

  2. Overall survival

    Time frame: 5 year

    Survival of the patient from any disease

  3. Disease specific survival

    Time frame: 5 years

    Survival of the patient from laryngeal disease

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2023
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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