Quadrant Versus Superficial Parotidectomy

Phase 2

Withdrawn

• Conditions: Pleomorphic Adenoma of the Parotid Gland
• Interventions: Procedure: Superficial parotidectomy; Procedure: Quadrant parotidectomy

• Registration Number: NCT01607866
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-30
• Study Start: 2014-06
• Primary Completion: 2016-07
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Superficial parotidectomy	Superficial parotidectomy	Patients in this group will receive superficial parotidectomy
Quadrant parotidectomy	Quadrant parotidectomy	Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor

Primary Outcome Measures

Name	Time	Method
Number of participants with permanent facial nerve palsy	measured six months after the date of surgery	using clinical neurological examination

Secondary Outcome Measures

Name	Time	Method
Operative time in minutes	Measured at the time of surgery	Median and range of operative time per intervention arm will be recorded
Number of participants with temporary facial nerve palsy	Measured at one day and at three months from the date of surgery.	using clinical neurological examination

Trial Locations

Locations (1)

Mansoura University Cancer Center; 🇪🇬 Mansoura, Dakahlia, Egypt