Pleomorphic Adenoma of the Parotid GlandPhase 2/3NCT01607866
Quadrant Versus Superficial Parotidectomy
A Phase 2/3 study testing Quadrant parotidectomy and Superficial parotidectomy in people with Pleomorphic Adenoma of the Parotid Gland, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pleomorphic Adenoma of the Parotid Gland
- What is being tested?
- Quadrant parotidectomy and Superficial parotidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Oct 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with pleomorphic adenoma of the parotid gland with Cytology- proven diagnosis
Who cannot join
- Collagen diseases
- Previous parotid surgery
- Previous facial nerve palsy
- Neuromuscular diseases affecting the face
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Cancer Center
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma
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.
Read the 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.
- Conditions
- Pleomorphic Adenoma of the Parotid Gland
- Being tested
- Quadrant parotidectomy, Superficial parotidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrant parotidectomyProcedure or surgery
Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland
Superficial parotidectomyProcedure or surgery
Excision of the whole superficial lobe of the parotid gland
| Study group | Role | What they receive |
|---|---|---|
| Quadrant parotidectomy | Experimental | Patients in this arm will receive excision of the parotid gland quadrant harboring the tumor Receives: Procedure: Quadrant parotidectomy |
| Superficial parotidectomy | Active comparator | Patients in this group will receive superficial parotidectomy Receives: Procedure: Superficial parotidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with permanent facial nerve palsy
using clinical neurological examination
Measured: measured six months after the date of surgery
Secondary outcomes (2)
Number of participants with temporary facial nerve palsy
using clinical neurological examination
Measured: Measured at one day and at three months from the date of surgery.
Operative time in minutes
Median and range of operative time per intervention arm will be recorded
Measured: Measured at the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionOct 2016
Why it stopped: Lack of enrollment of eligible patients for randomization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pleomorphic Adenoma of the Parotid GlandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Hussein, Mansoura University
- Investigators
- Osama Hussein, MD, PhD, Principal investigator, Mansoura UniversityAdel Denewer, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607866
- Sponsor's protocol ID
- R/89
- Status last verified
- Nov 2016
- First submitted
- 24 May 2012
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21417969Prichard 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.
PubMed 1328626
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadrant Parotidectomy Versus Superficial Parotidectomy for Treatment of Pleomorphic Adenoma
- ClinicalTrials.gov ID
- NCT01607866
- Acronym / sponsor ID
- R/89
- Conditions
- Pleomorphic Adenoma of the Parotid Gland
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment of eligible patients for randomization.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrant parotidectomy | Experimental | Procedure: Quadrant parotidectomyPatients in this arm will receive excision of the parotid gland quadrant harboring the tumor |
| Superficial parotidectomy | Active comparator | Procedure: Superficial parotidectomyPatients in this group will receive superficial parotidectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with pleomorphic adenoma of the parotid gland with Cytology- proven diagnosis
Key exclusion criteria (5 listed)
- Collagen diseases
- Previous parotid surgery
- Previous facial nerve palsy
- Neuromuscular diseases affecting the face
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrant parotidectomyExcision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland | Procedure or surgery | Quadrant parotidectomy |
| Superficial parotidectomyExcision of the whole superficial lobe of the parotid gland | Procedure or surgery | Superficial parotidectomy |
Primary outcome
Number of participants with permanent facial nerve palsy
Time frame: measured six months after the date of surgery
using clinical neurological examination
2 secondary outcomes
Number of participants with temporary facial nerve palsy
Time frame: Measured at one day and at three months from the date of surgery.
Operative time in minutes
Time frame: Measured at the time of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Background: PubMed 21417969Uyar 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.
- Background: PubMed 1328626Prichard 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Hussein, MD, PhD principal investigator
Mansoura University
Adel Denewer, MD study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Quadrant parotidectomy and Superficial parotidectomy in people with Pleomorphic Adenoma of the Parotid Gland, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with permanent facial nerve palsy (time frame: measured six months after the date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607866, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.