Back to resultsSurgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
Primary Purpose
Adenocarcinoma; Mucoepidermoid Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
resection of mucoeidermoid carcinoma
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma; Mucoepidermoid Carcinoma focused on measuring salivary gland tumor
Eligibility Criteria
Inclusion Criteria:
- patients suffering from salivary gland tumor
Exclusion Criteria:
- healthy patients with no tumors
Sites / Locations
- Ain shams university
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Control
Arm Description
Standard resection
Outcomes
Primary Outcome Measures
Quality of life
in grades the quality of life of patients is assessed by visual analogue scale in a scale from 1-10. higher values indicates better quality of life
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03988959
Brief Title
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
Official Title
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded
Detailed Description
This case series presents mucoepidermoid carcinoma. Palatal mass was resected with safety margin then immediate opturator inserted; superficial parotidectomy was also done for parotid lesion sparing facial nerve. Post-operative radiotherapy was recommended by pathologist due to evident perineural spread. The patient is tumor free after one year follow-up.
Clinical reports about synchronous multiple salivary tumors are very rare, consequently there is little known about its management and clinical presentation. Presence of one or more risk factor should favor expectation of multiple tumors and mandate examination of all salivary tissues. Each tumor should be diagnosed and treated separately according to its nature and extension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma; Mucoepidermoid Carcinoma
Keywords
salivary gland tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a case series was performed on 7 patients having mucoepidermoid carcinoma
Masking
None (Open Label)
Masking Description
No masking was done since its a case series
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Standard resection
Intervention Type
Procedure
Intervention Name(s)
resection of mucoeidermoid carcinoma
Other Intervention Name(s)
Conservative superficial partoidectomy
Intervention Description
Surgical resection parotid with preservation of facial nerve
Primary Outcome Measure Information:
Title
Quality of life
Description
in grades the quality of life of patients is assessed by visual analogue scale in a scale from 1-10. higher values indicates better quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients suffering from salivary gland tumor
Exclusion Criteria:
healthy patients with no tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Diaa, Prof Dr
Organizational Affiliation
Dean of Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
11757
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share those data currently with other researchers
Learn more about this trial
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
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