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Quadrant Versus Superficial Parotidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01607866
Recruitment Status : Withdrawn (Lack of enrollment of eligible patients for randomization.)
First Posted : May 30, 2012
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
Osama Hussein, 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.

Condition or disease Intervention/treatment Phase
Pleomorphic Adenoma of the Parotid Gland Procedure: Quadrant parotidectomy Procedure: Superficial parotidectomy Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma
Study Start Date : June 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

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

Primary Outcome Measures :
  1. Number of participants with permanent facial nerve palsy [ Time Frame: measured six months after the date of surgery ]
    using clinical neurological examination

Secondary Outcome Measures :
  1. Number of participants with temporary facial nerve palsy [ Time Frame: Measured at one day and at three months from the date of surgery. ]
    using clinical neurological examination

  2. Operative time in minutes [ Time Frame: Measured at the time of surgery ]
    Median and range of operative time per intervention arm will be recorded

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01607866

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Mansoura University Cancer Center
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
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Principal Investigator: Osama Hussein, MD, PhD Mansoura University
Study Chair: Adel Denewer, MD Mansoura University
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Responsible Party: Osama Hussein, Associate Professor of Surgery, Mansoura University Identifier: NCT01607866    
Other Study ID Numbers: R/89
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Adenoma, Pleomorphic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed