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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective bilateral neck dissection in cN0 patients | Procedure | Radical modified type 3 selective bilaterale elective neck dissection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of bilateral neck dissection during hospitalization | Complications of bilateral neck dissection during hospitalization | Up to 15 days from salvage surgery |
| Overall survival | Survival of the patient from any disease |
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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).
Exclusion Criteria:
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Patient affected by recurrent laryngeal cancer, after failure of primary radiotherapy or conservative surgery, with clinically negative neck (cN0) and treated with salvage total laryngectomy and concomitant elective selective bilateral neck dissection (levels II-IV + VI).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stefano Settimi | Roma | Italy |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D007818 | Laryngeal Diseases |
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| 5 year |
| Disease specific survival | Survival of the patient from laryngeal disease | 5 years |
| D010039 |
| Otorhinolaryngologic Neoplasms |
| D012142 | Respiratory Tract Neoplasms |