Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis (SIAGLA)

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

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.

Study Overview

• Status: Completed
• Conditions: Lithiasis

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• France
  • Moselle
    • Metz, Moselle, France, 57085
      • CHR Metz Thionville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with submandibular sialolithiasis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of symptom	Absence or presence of symptoms associated to lithiasis	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of clinical signs	number of clinical signs of the clinical suspicion	Day 1
Number of intraoperative complications	number of intraoperative complications	Day 1
Number of post-operative complications	Number of post-operative complications	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): March 25, 2021
• Study Completion (ACTUAL): March 25, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (ACTUAL): May 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: classification; submandibular gland; sialendoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Salivary Gland Diseases; Calculi; Salivary Calculi; Lithiasis; Salivary Gland Calculi
• Other Study ID Numbers: 2021-01Obs-CHRMT

Drug and device information, study documents

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