Management of Warthin Tumor of Parotid Gland.

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05221736
Collaborator
(none)
20
1
1
18
1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound-Guided Ethanol Sclerotherapy (UGES)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & Surgical Excision in Management of Warthin Tumor of Parotid Gland.
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Primary (main): [1 year]

      Rate of curability in each group

    Secondary Outcome Measures

    1. Secondary (subsidiary): [1 week]

      Rate of facial nerve injury in each group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Hamdan S. Abbas, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    kerolos nashaat hosny, assistant lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05221736
    Other Study ID Numbers:
    • Warthin tumor of parotid gland
    First Posted:
    Feb 3, 2022
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2022