CompletedNot Applicable

Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

Italy80 participantsStarted 2020-09-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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).

What they're measuring

Occult lymph node metastasis

Timeframe: At the time of salvage surgery

Trial details

NCT IDNCT05746780

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-01

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