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Quadrant Versus Superficial Parotidectomy

Primary Purpose

Pleomorphic Adenoma of the Parotid Gland

Status
Withdrawn
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Quadrant parotidectomy
Superficial parotidectomy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleomorphic Adenoma of the Parotid Gland

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quadrant parotidectomy

Superficial parotidectomy

Arm Description

Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor

Patients in this group will receive superficial parotidectomy

Outcomes

Primary Outcome Measures

Number of participants with permanent facial nerve palsy
using clinical neurological examination

Secondary Outcome Measures

Number of participants with temporary facial nerve palsy
using clinical neurological examination
Operative time in minutes
Median and range of operative time per intervention arm will be recorded

Full Information

First Posted
May 24, 2012
Last Updated
November 7, 2016
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01607866
Brief Title
Quadrant Versus Superficial Parotidectomy
Official Title
Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment of eligible patients for randomization.
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleomorphic Adenoma of the Parotid Gland

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadrant parotidectomy
Arm Type
Experimental
Arm Description
Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor
Arm Title
Superficial parotidectomy
Arm Type
Active Comparator
Arm Description
Patients in this group will receive superficial parotidectomy
Intervention Type
Procedure
Intervention Name(s)
Quadrant parotidectomy
Intervention Description
Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland
Intervention Type
Procedure
Intervention Name(s)
Superficial parotidectomy
Intervention Description
Excision of the whole superficial lobe of the parotid gland
Primary Outcome Measure Information:
Title
Number of participants with permanent facial nerve palsy
Description
using clinical neurological examination
Time Frame
measured six months after the date of surgery
Secondary Outcome Measure Information:
Title
Number of participants with temporary facial nerve palsy
Description
using clinical neurological examination
Time Frame
Measured at one day and at three months from the date of surgery.
Title
Operative time in minutes
Description
Median and range of operative time per intervention arm will be recorded
Time Frame
Measured at the time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Hussein, MD, PhD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adel Denewer, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Cancer Center
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
21417969
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.
Results Reference
background
PubMed Identifier
1328626
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.
Results Reference
background

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Quadrant Versus Superficial Parotidectomy

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