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Management of Warthin Tumor of Parotid Gland.

Primary Purpose

Warthin's Tumor of Parotid Gland

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound-Guided Ethanol Sclerotherapy (UGES)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warthin's Tumor of Parotid Gland

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All new cases presented with benign parotid cyst and diagnosed as Warthin tumour in the parotid gland.

Exclusion Criteria:

  • Other Parotid gland tumours e.g. solid tumours, malignant tumours and other suspicious tumours.

Sites / Locations

  • Assiut universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Warthin tumor in parotid tumor

Arm Description

Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & surgical excision in management of warthin tumor of parotid gland.

Outcomes

Primary Outcome Measures

Primary (main):
Rate of curability in each group

Secondary Outcome Measures

Secondary (subsidiary):
Rate of facial nerve injury in each group

Full Information

First Posted
January 7, 2022
Last Updated
January 23, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05221736
Brief Title
Management of Warthin Tumor of Parotid Gland.
Official Title
Comparison Between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & Surgical Excision in Management of Warthin Tumor of Parotid Gland.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & surgical excision in management of warthin tumor of parotid gland.
Detailed Description
Warthin tumor (also known as cystadenolymphoma), is a benign and frequent salivary gland neoplasm. It represents about 2% to 15% of all primary epithelial tumors of the parotid gland. Warthin tumor is histologically characterized by a dense lymphoid stroma and a double layer of oncocytic epithelium with a papillary and cystic architectural pattern. Its etiology: remains controversial. Incidence: It is the second most frequent benign neoplasm of the salivary glands after pleomorphic adenoma. Pathophysiology: Initially, Hildebrand proposed that the lesion may be remnants of the branchial pouches and a variant of the lateral cervical cyst. Later, Albrech and Artz proposed the heterotropic origin of Warthin tumor from the neoplastic proliferation of salivary gland ducts present within intra- or para-parotid nodes. Histopathology: Grossly, Warthin tumor is a well-circumscribed spherical to oval mass. On cut section, there are solid areas and multiple cysts with papillary projections. Cytology: Smears characteristically show oncocytic epithelial cells without atypia admixed with polymorphous lymphocytes and cellular debris. Microscopic Findings: Warthin tumors are composed of varying proportions of papillary- cystic structures lined by oncocytic epithelial cells and a lymphoid stroma with germinal centers. Clinically, Warthin tumor presents as a rounded or an ovoid nodular painless, slow-growing, fluctuant to firm at palpation. It can be unilateral, bilateral, or multicentric and is asymptomatic in 90% of cases. Prognosis: Warthin's tumor has a favorable prognosis and almost never recurs. Malignant degeneration of Warthin tumor is very rare. Complications: Local Recurrence; The local recurrence rate is low; when recurrence does occur, it is probably due to multifocal tumors or inadequate excision. Malignant Transformation; Malignant transformation in a Warthin tumor is extremely rare. The most frequent histological types of malignant transformation in a Warthin tumor are mucoepidermoid carcinoma, squamous cell carcinoma, undifferentiated carcinoma, oncocytic adenocarcinoma, and adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warthin's Tumor of Parotid Gland

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Warthin tumor in parotid tumor
Arm Type
Experimental
Arm Description
Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & surgical excision in management of warthin tumor of parotid gland.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-Guided Ethanol Sclerotherapy (UGES)
Other Intervention Name(s)
Surgical excision
Intervention Description
Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & surgical excision in management of warthin tumor of parotid gland.
Primary Outcome Measure Information:
Title
Primary (main):
Description
Rate of curability in each group
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Secondary (subsidiary):
Description
Rate of facial nerve injury in each group
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All new cases presented with benign parotid cyst and diagnosed as Warthin tumour in the parotid gland. Exclusion Criteria: Other Parotid gland tumours e.g. solid tumours, malignant tumours and other suspicious tumours.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerolos N. Hosny
Phone
+201033216963
Email
kerolosnashaat93@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamdan S. Abbas
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
age, sex , clinical diagnosis
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
age, sex , clinical diagnosis

Learn more about this trial

Management of Warthin Tumor of Parotid Gland.

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