Pleomorphic Adenoma of the Parotid Gland Clinical Trial
Official title:
Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma
The most common benign tumor of the parotid gland is the so called pleomorphic adenoma. Although benign, this tumor may recur after surgical removal due to tumor cells left behind during the surgical operation. Thus, pleomorphic adenomas have been treated with wide resection similar to malignant tumors. This extensive surgery often leads to injury to the motor nerves responsible for facial expression and eye protection. The investigators propose less extensive surgery which should be thorough enough to prevent tumor recurrence while keeping the facial nerve out of risk.
Pleomorphic adenoma is notorious of its propensity to local recurrence due to the
microscopic extracapsular extension of the tumor. Superficial parotidectomy (SP) is the
standard treatment. Extracapsular dissection (ED) has been proposed to minimize the risk of
facial nerve palsy. However, the oncologic safety of ED is controversial in the literature.
We propose quadrant parotidectomy (QP) which is less radical than SP and less conservative
than ED. QP entails dissection overlying one primary division of the facial nerve leaving
the other division undisturbed while the resection safety margin is still generous.
Surgery for pleomorphic adenoma is a compromise between radicality and facial nerve
morbidity. Risk of local recurrence is imprecisely described in the literature and is
universally regarded as infrequent and remote. Many studies did not report recurrent cases.
Thus, Facial nerve injury is the main concern of parotid surgeons and is considered the
primary end point of this study.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment