Clinical trial NCT01607866: Quadrant Versus Superficial Parotidectomy
Official title: Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Pleomorphic Adenoma of the Parotid Gland
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients with pleomorphic adenoma of the parotid gland with Cytology- proven diagnosis

Exclusion Criteria:

* Collagen diseases
* Previous parotid surgery
* Previous facial nerve palsy
* Neuromuscular diseases affecting the face
* Patient refusal

Primary outcomes:
measure: Number of participants with permanent facial nerve palsy
timeFrame: measured six months after the date of surgery
Secondary outcomes:
measure: Number of participants with temporary facial nerve palsy
timeFrame: Measured at one day and at three months from the date of surgery.
measure: Operative time in minutes
timeFrame: Measured at the time of surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Cancer Center
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Osama Hussein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Adel Denewer, MD
role: STUDY_CHAIR
References:
citation: Uyar Y, Caglak F, Keles B, Yildirim G, Salturk Z. Extracapsular dissection versus superficial parotidectomy in pleomorphic adenomas of the parotid gland. Kulak Burun Bogaz Ihtis Derg. 2011 Mar-Apr;21(2):76-9. doi: 10.5606/kbbihtisas.2011.003.
citation: Prichard AJ, Barton RP, Narula AA. Complications of superficial parotidectomy versus extracapsular lumpectomy in the treatment of benign parotid lesions. J R Coll Surg Edinb. 1992 Jun;37(3):155-8.