Quadrant Versus Superficial Parotidectomy

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.

Study Overview

• Status: Withdrawn
• Conditions: Pleomorphic Adenoma of the Parotid Gland
• Intervention / Treatment: Procedure: Quadrant parotidectomy; Procedure: Superficial parotidectomy

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 Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Mansoura University Cancer center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrant parotidectomy; Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor	Procedure: Quadrant parotidectomy; Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland
Active Comparator: Superficial parotidectomy; Patients in this group will receive superficial parotidectomy	Procedure: Superficial parotidectomy; Excision of the whole superficial lobe of the parotid gland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with permanent facial nerve palsy	using clinical neurological examination	measured six months after the date of surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Osama Hussein, MD, PhD, Mansoura University; Study Chair: Adel Denewer, MD, Mansoura University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: May 25, 2012
• First Posted (Estimate): May 30, 2012

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 7, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Complex and Mixed; Adenoma; Adenoma, Pleomorphic
• Other Study ID Numbers: R/89