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Quadrant Versus Superficial Parotidectomy

NCT ID: NCT01607866

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Pleomorphic Adenoma of the Parotid Gland

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Quadrant parotidectomy

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

Group Type EXPERIMENTAL

Quadrant parotidectomy

Intervention Type PROCEDURE

Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland

Superficial parotidectomy

Patients in this group will receive superficial parotidectomy

Group Type ACTIVE_COMPARATOR

Superficial parotidectomy

Intervention Type PROCEDURE

Excision of the whole superficial lobe of the parotid gland

Interventions

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Quadrant parotidectomy

Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland

Intervention Type PROCEDURE

Superficial parotidectomy

Excision of the whole superficial lobe of the parotid gland

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Osama Hussein

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Hussein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Adel Denewer, MD

Role: STUDY_CHAIR

Mansoura University

Locations

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Mansoura University Cancer Center

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 21417969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1328626 (View on PubMed)

Other Identifiers

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R/89

Identifier Type: -

Identifier Source: org_study_id