Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis

Lithiasis Clinical Trial

— SIAGLA  

Official title:

Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886440
• Other study ID #: 2021-01Obs-CHRMT
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: March 25, 2021

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lithiasis

Locations

Country	Name	City	State
France	CHR Metz Thionville	Metz	Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of symptom	Absence or presence of symptoms associated to lithiasis	Month 6
Secondary	Number of clinical signs	number of clinical signs of the clinical suspicion	Day 1
Secondary	Number of intraoperative complications	number of intraoperative complications	Day 1
Secondary	Number of post-operative complications	Number of post-operative complications	Day 1