Quadrant Versus Superficial Parotidectomy

Pleomorphic Adenoma of the Parotid Gland Clinical Trial

Official title:

Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01607866
• Other study ID #: R/89
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: May 24, 2012
• Last updated: November 7, 2016
• Start date: June 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoma
• Adenoma, Pleomorphic
• Pleomorphic Adenoma of the Parotid Gland

Intervention

Procedure:
• Quadrant parotidectomy
Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland
• Superficial parotidectomy
Excision of the whole superficial lobe of the parotid gland

Locations

Country	Name	City	State
Egypt	Mansoura University Cancer Center	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

Uyar Y, Caglak F, Keles B, Yildirim G, Saltürk 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with permanent facial nerve palsy	using clinical neurological examination	measured six months after the date of surgery	No
Secondary	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.	No
Secondary	Operative time in minutes	Median and range of operative time per intervention arm will be recorded	Measured at the time of surgery	No