Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis

Completed

• Conditions: Lithiasis

• Registration Number: NCT04886440
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-14
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of symptom	Month 6	Absence or presence of symptoms associated to lithiasis

Secondary Outcome Measures

Name	Time	Method
Number of intraoperative complications	Day 1	number of intraoperative complications
Number of clinical signs	Day 1	number of clinical signs of the clinical suspicion
Number of post-operative complications	Day 1	Number of post-operative complications

Trial Locations

Locations (1)

CHR Metz Thionville; 🇫🇷 Metz, Moselle, France