Unilateral versus bilateral palatine tonsillectomy in the carcinomas of unknown primary of the head and neck: a multicenter, randomized, controlled clinical trial

Abstract

BACKGROUND: The Head and Neck Carcinoma of Unknown Primary (HNCUP) is the histologically confirmed metastatic cancer in a cervical lymph node without the finding of a primary tumor at the time of the initial management. Its diagnosis evaluation has changed according to new scientific evidence, but these changes have not always been reflected in clinical practice. Despite the unilateral palatine tonsillectomy being postulated as the ideal and less aggressive alternative to the bilateral palatine tonsillectomy in its management, hospitals around the country still perform the bilateral approach because of the lack of experimental studies comparing both techniques. OBJECTIVES: The aim of this study is to prove that the unilateral palatine tonsillectomy in the management of the HNCUP is not inferior to the standard bilateral palatine tonsillectomy in terms of overall survival. When it comes to secondary objectives, we will assess the improvement in the quality of life (QoL) during the postoperative period with the unilateral approach, as well as the reduction in surgical time, postoperative complications, days of hospitalization, and costs of this pathology management. DESIGN: This study is designed as a multicenter, randomized, open-labelled clinical trial performed among reference Head and Neck hospitals from Spain, with the help and coordination from Sociedad Española de Otorrinolaringología y Cáncer de Cabeza y Cuello (SEORL-CCC). PARTICIPANTS: Adult patients with HNCUP from Spain with a squamous cell histology of the adenopathy and the sole detection of the adenopathy in the PET-CT scan. METHODS: 1.230 patients will be recruited consecutively in all hospitals with a Head and Neck unit from Spain and coordinated by the SEORL-CCC and a reference hospital in every autonomous community. Patients will be randomly assigned into two treatment groups: bilateral palatine tonsillectomy (A) and unilateral palatine tonsillectomy (B). Overall survival at the 5 years from the diagnosis will be assessed, as well as the QoL during the postoperative period, surgical time, postoperative complications, days of hospitalization and management costs