Quadrant Versus Superficial Parotidectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Osama Hussein, Mansoura University
ClinicalTrials.gov Identifier:
NCT01607866
First received: May 24, 2012
Last updated: June 22, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Pleomorphic Adenoma of the Parotid Gland
Procedure: Quadrant parotidectomy
Procedure: Superficial parotidectomy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Number of participants with permanent facial nerve palsy [ Time Frame: measured six months after the date of surgery ] [ Designated as safety issue: No ]
    using clinical neurological examination


Secondary Outcome Measures:
  • Number of participants with temporary facial nerve palsy [ Time Frame: Measured at one day and at three months from the date of surgery. ] [ Designated as safety issue: No ]
    using clinical neurological examination

  • Operative time in minutes [ Time Frame: Measured at the time of surgery ] [ Designated as safety issue: No ]
    Median and range of operative time per intervention arm will be recorded


Estimated Enrollment: 116
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607866

Contacts
Contact: Osama Hussein, MD,PhD +201099815110 osama.hussein@mail.mcgill.ca
Contact: Adel Denewer, MD +201223237791 adeldenewer@mans.edu.eg

Locations
Egypt
Mansoura University Cancer Center Recruiting
Mansoura, Dakahlia, Egypt, 35516
Sub-Investigator: Mahmoud Mosbah, MD         
Sub-Investigator: Mohamed Arafa, MD, PhD         
Sub-Investigator: Khalid Abdel-Wahhab, MSc         
Sub-Investigator: Ahmed Abdellah, MSc         
Sub-Investigator: Osama El-Damshety, MSc         
Sub-Investigator: Mohamed Tarek, MD         
Sub-Investigator: Sameh Roshdy, MD         
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Osama Hussein, MD, PhD Mansoura University
Study Chair: Adel Denewer, MD Mansoura University
  More Information

Publications:
Responsible Party: Osama Hussein, Associate Professor of Surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT01607866     History of Changes
Other Study ID Numbers: R/89
Study First Received: May 24, 2012
Last Updated: June 22, 2014
Health Authority: Egypt: Ministry of Higher Education

Additional relevant MeSH terms:
Adenoma
Adenoma, Pleomorphic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on July 23, 2014