Management of Warthin Tumor of Parotid Gland.

Comparison Between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & Surgical Excision in Management of Warthin Tumor of Parotid Gland.

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

Study Overview

• Status: Recruiting
• Conditions: Warthin's Tumor of Parotid Gland
• Intervention / Treatment: Procedure: Ultrasound-Guided Ethanol Sclerotherapy (UGES)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerolos N. Hosny; Phone Number: +201033216963; Email: kerolosnashaat93@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warthin tumor in parotid tumor; Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & surgical excision in management of warthin tumor of parotid gland.	Procedure: Ultrasound-Guided Ethanol Sclerotherapy (UGES); Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & surgical excision in management of warthin tumor of parotid gland.; Other Names: Surgical excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary (main):	Rate of curability in each group	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary (subsidiary):	Rate of facial nerve injury in each group	1 week

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Hamdan S. Abbas, Assiut university

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Neoplasms, Complex and Mixed; Salivary Gland Diseases; Mouth Neoplasms; Parotid Diseases; Salivary Gland Neoplasms; Parotid Neoplasms; Adenolymphoma; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: Warthin tumor of parotid gland

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: age, sex , clinical diagnosis
• IPD Sharing Time Frame: 3 years
• IPD Sharing Access Criteria: age, sex , clinical diagnosis
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No