Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis

NCT ID: NCT04886440

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-03-25

Brief Summary

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Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.

The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.

Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.

Detailed Description

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Conditions

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Lithiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patient
* Patient treated in CHR Metz-Thionville between 2013 and 2020
* With a pathological impairment (suspected or confirmed) of a salivary gland
* With sialendoscopy indication for diagnosis and/or treatment

Exclusion Criteria

* Opposed to use data
* Without sialendoscopy indication
* Without lithiasis salivary gland disorder
* With parotid gland lithiasis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHR Metz Thionville

Metz, Moselle, France

Site Status

Countries

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France

Other Identifiers

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2021-01Obs-CHRMT

Identifier Type: -

Identifier Source: org_study_id

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